Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-04-11 @ 11:58 PM
Study NCT ID:
NCT00562120
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2007-11-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093230', 'term': 'fexofenadine'}, {'id': 'C569672', 'term': 'N-ethyl-3-fluoro-3-(3-fluoro-4-(pyrrolidinylmethyl)phenyl)cyclobutanecarboxamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-03654746 10 mg', 'description': 'PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.', 'otherNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PF-03654746 1 mg', 'description': 'PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.', 'otherNumAtRisk': 19, 'otherNumAffected': 2, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Allegra-D', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.', 'otherNumAtRisk': 19, 'otherNumAffected': 2, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03654746 10 mg', 'description': 'PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG001', 'title': 'PF-03654746 1 mg', 'description': 'PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG002', 'title': 'Allegra-D', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.760', 'spread': '0.1504', 'groupId': 'OG000'}, {'value': '0.742', 'spread': '0.2552', 'groupId': 'OG001'}, {'value': '0.717', 'spread': '0.1935', 'groupId': 'OG002'}, {'value': '0.795', 'spread': '0.3044', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.302', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.134', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.229', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.544', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.710', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.816', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period', 'description': "Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hours (hrs) 10 minutes (min), 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin 'post-allergen challenge' measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single 'post-allergen challenge' value. Amin proportion was defined as ratio of 'post-allergen challenge' value and 'Baseline/pre-allergen challenge value'. Diluent used was saline and allergen was short ragweed extract.", 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.'}, {'type': 'PRIMARY', 'title': 'Nasal Volume Proportion Measured Using Acoustic Rhinometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03654746 10 mg', 'description': 'PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG001', 'title': 'PF-03654746 1 mg', 'description': 'PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG002', 'title': 'Allegra-D', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.800', 'spread': '0.1825', 'groupId': 'OG000'}, {'value': '0.796', 'spread': '0.2641', 'groupId': 'OG001'}, {'value': '0.744', 'spread': '0.1594', 'groupId': 'OG002'}, {'value': '0.856', 'spread': '0.3859', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.269', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.097', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.252', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.479', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.521', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.952', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period', 'description': "Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Nasal volume at Baseline was defined as mean of 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume 'post-allergen challenge' measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single 'post-allergen challenge' value. Nasal volume proportion was defined as ratio of 'post-allergen challenge' value and 'Baseline/pre-allergen challenge value'. Diluent used was saline and allergen was short ragweed extract.", 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.'}, {'type': 'SECONDARY', 'title': 'Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03654746 10 mg', 'description': 'PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG001', 'title': 'PF-03654746 1 mg', 'description': 'PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG002', 'title': 'Allegra-D', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.155', 'spread': '0.0876', 'groupId': 'OG000'}, {'value': '0.157', 'spread': '0.1159', 'groupId': 'OG001'}, {'value': '0.204', 'spread': '0.0951', 'groupId': 'OG002'}, {'value': '0.190', 'spread': '0.1510', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.130', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.663', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.138', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.124', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.134', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.978', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period', 'description': "Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of the 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin 'post-allergen challenge' measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall in Amin was calculated as baseline measure minus smallest 'post-allergen challenge' Amin measurement of the 3 measures.", 'unitOfMeasure': 'square centimeter (cm^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.'}, {'type': 'SECONDARY', 'title': 'Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03654746 10 mg', 'description': 'PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG001', 'title': 'PF-03654746 1 mg', 'description': 'PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG002', 'title': 'Allegra-D', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.132', 'spread': '2.4120', 'groupId': 'OG000'}, {'value': '3.244', 'spread': '2.3676', 'groupId': 'OG001'}, {'value': '4.443', 'spread': '2.9502', 'groupId': 'OG002'}, {'value': '3.275', 'spread': '2.7001', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.357', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.952', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.480', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.043', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.087', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.753', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period', 'description': "Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Nasal volume at Baseline was defined as mean of the 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume 'post-allergen challenge' measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall for nasal volume was calculated as baseline measure minus smallest 'post-allergen challenge' nasal volume measurement among the 3 measures.", 'unitOfMeasure': 'cubic centimeter (cm^3)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.'}, {'type': 'SECONDARY', 'title': 'Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03654746 10 mg', 'description': 'PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG001', 'title': 'PF-03654746 1 mg', 'description': 'PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG002', 'title': 'Allegra-D', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}], 'classes': [{'title': 'Nasal congestion: Pre-allergen challenge', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.57', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.59', 'groupId': 'OG003'}]}]}, {'title': 'Nasal congestion: Post-allergen challenge', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.30', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.42', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '1.48', 'groupId': 'OG003'}]}]}, {'title': 'Nasal congestion: Post-oxymetazoline', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.85', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '1.20', 'groupId': 'OG003'}]}]}, {'title': 'Nasal Itching: Pre-allergen challenge', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.08', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.31', 'groupId': 'OG003'}]}]}, {'title': 'Nasal Itching: Post-allergen challenge', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.12', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '1.43', 'groupId': 'OG003'}]}]}, {'title': 'Rhinorrhea: Pre-allergen challenge', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.33', 'groupId': 'OG003'}]}]}, {'title': 'Rhinorrhea: Post-allergen challenge', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.48', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.30', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '1.42', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.127', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.103', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.218', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.905', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.273', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.055', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.012', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.048', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.496', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.190', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.061', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.778', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.102', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Pre-allergen challenge); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose (Post-allergen challenge); 3 hrs 40 min post dose (Post-oxymetazoline) on Day 1 of each intervention period', 'description': "Nasal symptoms included; nasal congestion: participants rated sensation of nasal blockage on 0 (no blockage) to 5 (total blockage) scale, nasal itching: participants rated sensation of nasal itch on 0 (no itch) to 5 (very itchy) scale, rhinorrhea: participants rated sensation of runny nose on 0 (no running) to 5 (very runny) scale. Symptom scores were assessed as mean of each intervention period at specified time-points for 'post-diluent, pre-allergen challenge' measure and 'post-challenge' measure. Post-diluent, pre-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and post-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period and (for congestion only) 3 hrs 40 min post PF-03654746/placebo dose (Post-oxymetazoline) at each intervention period.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.'}, {'type': 'SECONDARY', 'title': 'Nasal Symptom Scores: Sneezing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03654746 10 mg', 'description': 'PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG001', 'title': 'PF-03654746 1 mg', 'description': 'PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG002', 'title': 'Allegra-D', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}], 'classes': [{'title': 'Sneezing: Pre-allergen challenge', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.17', 'groupId': 'OG003'}]}]}, {'title': 'Sneezing: Post-allergen challenge', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.92', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.94', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '3.24', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.000', 'groupIds': ['OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.000', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on a one-sided test. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.217', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.156', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.848', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.', 'groupDescription': 'An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period', 'description': "The absolute number of sneezes was recorded by the participants under supervision of study personnel. Nasal symptom score for sneezing was assessed as the total number of sneezes of each intervention period at specified time-points for the post-diluent and post-challenge and post where 'post-diluent, pre-allergen challenge' included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and 'post-allergen challenge' included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period.", 'unitOfMeasure': 'sneezes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Serum PF-03654746 Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-03654746 10 mg', 'description': 'PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}, {'id': 'OG001', 'title': 'PF-03654746 1 mg', 'description': 'PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.16', 'spread': '17.85', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '1.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hr 30 min post dose on Day 1 of each intervention period', 'description': 'Only participants receiving PF-03654746 were analyzed for this outcome measure. Mean serum concentration of PF-03654746 was calculated of each intervention period.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-03654746 10 mg, Placebo, PF-03654746 1 mg, Allegra-D', 'description': 'PF-03654746 10 milligram (mg) capsule and Allegra (fexofenadine 60 mg) tablet-in-capsule along with placebo matched to Allegra-D (fexofenadine 60 mg in combination with pseudoephedrine 120 mg) tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.'}, {'id': 'FG001', 'title': 'PF-03654746 1 mg, PF-03654746 10 mg, Allegra-D, Placebo', 'description': 'PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule and Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.'}, {'id': 'FG002', 'title': 'Allegra-D, PF-03654746 1 mg, Placebo, PF-03654746 10 mg', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.'}, {'id': 'FG003', 'title': 'Placebo, Allegra-D, PF-03654746 10 mg, PF-03654746 1 mg', 'description': 'Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.'}], 'periods': [{'title': 'First Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized but not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 1 (At Least 14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 2 (At Least 14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 3 (At Least 14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Fourth Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'All participants randomized to any treatment (PF-03654746 10 mg capsule first, PF-03654746 1 mg capsule first, Allegra-D tablet-in-capsule first and placebo first).'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 44 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': '45 to 64 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'dispFirstSubmitDate': '2009-03-24', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-10', 'studyFirstSubmitDate': '2007-11-19', 'dispFirstSubmitQcDate': '2010-11-12', 'resultsFirstSubmitDate': '2014-03-10', 'studyFirstSubmitQcDate': '2007-11-19', 'dispFirstPostDateStruct': {'date': '2010-11-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-10', 'studyFirstPostDateStruct': {'date': '2007-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum PF-03654746 Concentration', 'timeFrame': '1 hr 30 min post dose on Day 1 of each intervention period', 'description': 'Only participants receiving PF-03654746 were analyzed for this outcome measure. Mean serum concentration of PF-03654746 was calculated of each intervention period.'}], 'primaryOutcomes': [{'measure': 'Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry', 'timeFrame': '2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period', 'description': "Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hours (hrs) 10 minutes (min), 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin 'post-allergen challenge' measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single 'post-allergen challenge' value. Amin proportion was defined as ratio of 'post-allergen challenge' value and 'Baseline/pre-allergen challenge value'. Diluent used was saline and allergen was short ragweed extract."}, {'measure': 'Nasal Volume Proportion Measured Using Acoustic Rhinometry', 'timeFrame': '2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period', 'description': "Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Nasal volume at Baseline was defined as mean of 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume 'post-allergen challenge' measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single 'post-allergen challenge' value. Nasal volume proportion was defined as ratio of 'post-allergen challenge' value and 'Baseline/pre-allergen challenge value'. Diluent used was saline and allergen was short ragweed extract."}], 'secondaryOutcomes': [{'measure': 'Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry', 'timeFrame': '2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period', 'description': "Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of the 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin 'post-allergen challenge' measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall in Amin was calculated as baseline measure minus smallest 'post-allergen challenge' Amin measurement of the 3 measures."}, {'measure': 'Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry', 'timeFrame': '2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period', 'description': "Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Nasal volume at Baseline was defined as mean of the 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume 'post-allergen challenge' measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall for nasal volume was calculated as baseline measure minus smallest 'post-allergen challenge' nasal volume measurement among the 3 measures."}, {'measure': 'Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea', 'timeFrame': '2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Pre-allergen challenge); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose (Post-allergen challenge); 3 hrs 40 min post dose (Post-oxymetazoline) on Day 1 of each intervention period', 'description': "Nasal symptoms included; nasal congestion: participants rated sensation of nasal blockage on 0 (no blockage) to 5 (total blockage) scale, nasal itching: participants rated sensation of nasal itch on 0 (no itch) to 5 (very itchy) scale, rhinorrhea: participants rated sensation of runny nose on 0 (no running) to 5 (very runny) scale. Symptom scores were assessed as mean of each intervention period at specified time-points for 'post-diluent, pre-allergen challenge' measure and 'post-challenge' measure. Post-diluent, pre-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and post-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period and (for congestion only) 3 hrs 40 min post PF-03654746/placebo dose (Post-oxymetazoline) at each intervention period."}, {'measure': 'Nasal Symptom Scores: Sneezing', 'timeFrame': '2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period', 'description': "The absolute number of sneezes was recorded by the participants under supervision of study personnel. Nasal symptom score for sneezing was assessed as the total number of sneezes of each intervention period at specified time-points for the post-diluent and post-challenge and post where 'post-diluent, pre-allergen challenge' included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and 'post-allergen challenge' included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8801003&StudyName=A%20study%20to%20test%20a%20new%20decongestant%20in%20patients%20with%20allergic%20rhinitis%20following%20a%20nasal%20allergen%20challenge', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic rhinometry will be used to measure the congestion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects 19-55 years with allergic rhinitis requiring treatment within the previous 2 years.\n* Subjects that respond to a ragweed nasal allergen challenge at screening.\n\nExclusion Criteria:\n\n* History of asthma or FEV1 \\< 80% predicted.\n* Significant concomitant disease or medications.\n* Symptoms of allergic rhinitis within 2 weeks prior to screening.'}, 'identificationModule': {'nctId': 'NCT00562120', 'briefTitle': 'A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Double Blind, Double Dummy, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of An H3 Receptor Antagonist (PF-03654746) On Congestion Following A Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis.', 'orgStudyIdInfo': {'id': 'A8801003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Allegra', 'interventionNames': ['Drug: Allegra']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Allegra-D', 'interventionNames': ['Drug: Allegra-D']}, {'type': 'EXPERIMENTAL', 'label': 'PF-03654746', 'interventionNames': ['Drug: PF-03654746']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'A single oral dose of Placebo is dosed during the study in order to ascertain the effect of placebo on measures and in order to maintain the blind of the other drugs.', 'armGroupLabels': ['Placebo']}, {'name': 'Allegra', 'type': 'DRUG', 'description': 'A single oral dose of Allegra is dosed to subjects in combination with PF-03654746.', 'armGroupLabels': ['Allegra']}, {'name': 'Allegra-D', 'type': 'DRUG', 'description': 'A single oral dose of Allegra-D is dosed to subjects as an active comparator.', 'armGroupLabels': ['Allegra-D']}, {'name': 'PF-03654746', 'type': 'DRUG', 'description': 'A single oral dose of PF-03654746 is the investigational drug being studied.', 'armGroupLabels': ['PF-03654746']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}