Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT01033669
Status:
COMPLETED
Last Update Posted:
2010-03-17
First Post:
2009-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment Of The Inhalation Profiles Of Four Dry Powder Inhalers In Patients With Variable Degrees Of Lung Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-15', 'studyFirstSubmitDate': '2009-09-24', 'studyFirstSubmitQcDate': '2009-12-15', 'lastUpdatePostDateStruct': {'date': '2010-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Inspiratory Flow Rate', 'timeFrame': 'Day 3-10'}], 'secondaryOutcomes': [{'measure': 'Pressure Slope', 'timeFrame': 'Day 3-10'}, {'measure': 'Peak Pressure Drop', 'timeFrame': 'Day 3-10'}, {'measure': 'Time to Peak Pressure Drop', 'timeFrame': 'Day 3-10'}, {'measure': 'Inhaled Volume', 'timeFrame': 'Day 3-10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inhalation profiles', 'asthma', 'COPD'], 'conditions': ['Asthma', 'Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9011071&StudyName=Assessment%20Of%20The%20Inhalation%20Profiles%20Of%20Four%20Dry%20Powder%20Inhalers%20In%20Patients%20With%20Variable%20Degrees%20Of%20Lung%20Obstruction', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction', 'detailedDescription': 'Randomized to device sequence'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Asthma and COPD patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with a physician documented history or diagnosis of asthma for at least 6 months\n* Reversibility, defined as an increase in FEV1 at the Screening visit of greater than or equal to 12% and 200 mL\n* Subjects with a physician documented history or diagnosis of mild or severe Chronic Obstructive Pulmonary Disease\n\nExclusion Criteria:\n\n* Female subjects who are pregnant\n* Subjects who have a history of life-threatening asthma/COPD or who have experienced two or more exacerbations requiring hospitalization in the 12 months prior to screening\n* Evidence of lower respiratory tract infection\n* Subjects diagnosed with pulmonary fibrosis, bronchiectasis, pneumoconiosis, sarcoidosis or tuberculosis'}, 'identificationModule': {'nctId': 'NCT01033669', 'briefTitle': 'Assessment Of The Inhalation Profiles Of Four Dry Powder Inhalers In Patients With Variable Degrees Of Lung Obstruction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized Cross-Over Study Investigating The Inhalation Profiles Of Four Dry Powder Inhalation Devices In Subjects With Asthma And Chronic Obstructive Pulmonary Disease.', 'orgStudyIdInfo': {'id': 'A9011071'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dry Powder Inhalers', 'interventionNames': ['Device: CRC-749', 'Device: Diskus', 'Device: Twisthaler', 'Device: Miat Monohaler']}], 'interventions': [{'name': 'CRC-749', 'type': 'DEVICE', 'description': 'There is no drug being used. This is a device.', 'armGroupLabels': ['Dry Powder Inhalers']}, {'name': 'Diskus', 'type': 'DEVICE', 'description': 'There is no drug being used. This is a device.', 'armGroupLabels': ['Dry Powder Inhalers']}, {'name': 'Twisthaler', 'type': 'DEVICE', 'description': 'There is no drug being used. This is a device.', 'armGroupLabels': ['Dry Powder Inhalers']}, {'name': 'Miat Monohaler', 'type': 'DEVICE', 'description': 'There is no drug being used. This is a device.', 'armGroupLabels': ['Dry Powder Inhalers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}