Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-02-25 @ 4:39 PM
Study NCT ID:
NCT06350461
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2024-04-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'margaret.kloster@seattlechildrens.org', 'phone': '206-884-7862', 'title': 'Margaret Kloster', 'organization': "Seattle Children's"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From randomization (Week 0) up to last study visit (Week 6), i.e., 6 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.', 'otherNumAtRisk': 184, 'deathsNumAtRisk': 184, 'otherNumAffected': 5, 'seriousNumAtRisk': 184, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%.", 'otherNumAtRisk': 186, 'deathsNumAtRisk': 186, 'otherNumAffected': 10, 'seriousNumAtRisk': 186, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change in FEV1 % Predicted From Week 0 to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.'}, {'id': 'OG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '3.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.324', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.6', 'pValueComment': 'One-sided test for non-inferiority', 'estimateComment': 'Direction of difference is Discontinue - Continue.', 'groupDescription': 'The non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Adjusted for four dichotomous randomization strata.', 'nonInferiorityComment': 'The non-inferiority margin is -3.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the absolute change in FEV1 % predicted from Week 0 to Week 6.', 'unitOfMeasure': 'FEV1 % predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in LCI 2.5 From Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.'}, {'id': 'OG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%."}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.733', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'estimateComment': 'Direction of difference is Discontinue - Continue', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for four dichotomous randomization strata.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0 or Week -2) to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the absolute change in LCI 2.5 (Lung Clearance Index) from Baseline (Week 0, if available, or else Week -2) to Week 6. LCI 2.5 is the number of times the volume in the lungs needs to turn over to expel an inert gas. A higher value of LCI 2.5 indicates poorer lung function.', 'unitOfMeasure': 'number of lung volume turnovers', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the per-protocol (PP) population with an acceptable LCI 2.5 measurement at baseline and at Week 6.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) From Week 0 to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.'}, {'id': 'OG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '11.02', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '9.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.226', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.52', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '0.9', 'estimateComment': 'Direction of difference is Discontinue - Continue.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for four dichotomous randomization strata.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 6', 'description': "Difference between study arms (discontinue - continue) in the absolute change in respiratory symptoms, as measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) from Week 0 to Week 6. The Cystic Fibrosis Respiratory Symptoms Daily Diary (CFRSD) asks a participant to state the extent of their 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms. Calculation of a score requires responses for at least 7 out of 8 symptoms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the per-protocol (PP) population with a CRISS score at Week 0 and Week 6'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Respiratory Symptoms, as Measured by CFQ-R Respiratory Domain From Week 0 to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.'}, {'id': 'OG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%."}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '9.56', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '6.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.857', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '2.1', 'estimateComment': 'Direction of the difference is Discontinue - Continue', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for four dichotomous randomization strata'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the absolute change in respiratory symptoms, as measured by the Cystic Fibrosis Questionnaire-Revised Respiratory Domain Score from Week 0 to Week 6. The Cystic Fibrosis Questionnaire - Revised asks participants 6 questions related to respiratory symptoms which are each assigned a score 1-4. The Respiratory Domain Scaled Score is calculated as follows: 100\\*\\[{sum of responses}/{number of responses}-1\\]/3 only if number of responses ≥ 3; otherwise the score is set to missing. The scaled score ranges from 0 to 100 where higher scores indicate improvement of symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the per-protocol (PP) population with a score at Week 0 and at Week 6'}, {'type': 'SECONDARY', 'title': 'Absolute Change in FEV1 % Predicted From Week -2 to Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.'}, {'id': 'OG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%."}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '3.63', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '3.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '1.54', 'estimateComment': 'Direction of the difference is Discontinue - Continue', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week -2 to Week 0', 'description': 'Difference between study arms (discontinue - continue) in the absolute change in FEV1 % predicted from Week -2 to Week 0.', 'unitOfMeasure': '% predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol (PP) population'}, {'type': 'SECONDARY', 'title': 'Absolute Change in FEV1 % Predicted From Week 0 to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.'}, {'id': 'OG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%."}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '3.66', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '0.57', 'estimateComment': 'Direction of the difference is Discontinue - Continue', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 2', 'description': 'Difference between study arms (discontinue - continue) in the absolute change in FEV1 % predicted from Week 0 to Week 2.', 'unitOfMeasure': '% predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the per-protocol (PP) population with FEV1 measurements at Week 0 and at Week 2'}, {'type': 'SECONDARY', 'title': 'Number and Percent of Participants Initiating Acute Antibiotics From Week 0 to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.'}, {'id': 'OG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%."}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.653', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in % Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '6.1', 'estimateComment': 'Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.', 'groupDescription': 'Null hypothesis: proportion of participants initiating acute antibiotics is the same in the Discontinue and Continue arms', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the percent of subjects initiating acute oral, inhaled or intravenous antibiotics from Week 0 to Week 6. Includes antibiotics initiated for respiratory indications; excludes those taken as part of a chronic cycled regimen or for a UTI, skin infection, etc.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population of all randomized participants'}, {'type': 'SECONDARY', 'title': 'Number and Percent of Participants Hospitalized From Week 0 to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.'}, {'id': 'OG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%."}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.622', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in % Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '3.4', 'estimateComment': 'Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.', 'groupDescription': 'Null hypothesis: proportion of participants with at least one hospitalization is the same in Discontinue and Continue arms.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the percent of subjects hospitalized from Week 0 to Week 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population of all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number and Percent of Participants Experiencing Pulmonary Exacerbations From Week 0 to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.'}, {'id': 'OG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%."}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.623', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in % Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '1.6', 'estimateComment': 'Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.', 'groupDescription': 'Null hypothesis: proportion of participants with at least one protocol-defined pulmonary exacerbation is the same in Discontinue and Continue arms.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the percent of subjects experiencing a pulmonary exacerbation from Week 0 to Week 6. Pulmonary exacerbations defined using Fuchs criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population of all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number and Percent of Participants Experiencing Adverse Events (AEs) From Week 0 to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.'}, {'id': 'OG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%."}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0165', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in % Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.7', 'ciLowerLimit': '2.4', 'ciUpperLimit': '20.7', 'estimateComment': 'Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.', 'groupDescription': 'Null hypothesis: proportion of participants with at least one AE is the same in Discontinue and Continue arms.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the percent of participants with at least one AE from Week 0 to Week 6. Includes serious and non-serious AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population of all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Rate of Adverse Events (AEs) From Week 0 to Week 6 Therapy Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.'}, {'id': 'OG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%."}], 'classes': [{'categories': [{'measurements': [{'value': '0.086', 'groupId': 'OG000'}, {'value': '0.067', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0958', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.74', 'groupDescription': 'Rate ratio, confidence interval, and p-value calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the HS-discontinue and HS-continue arms are 1135.7 and 1163.9 weeks, respectively. Ratio is Discontinue / Continue.', 'statisticalMethod': 'Poisson Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 6', 'description': 'Comparison of study arms (discontinue/continue) in the rate of AE occurrence (number of events divided by total follow-up weeks in each arm) from Week 0 to Week 6. Includes serious and non-serious AEs.', 'unitOfMeasure': 'events per week', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population of all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number and Percent of Participants With Temporary or Permanent Changes From Assigned Therapy Regimen Due to Adverse Event From Week 0 to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.'}, {'id': 'OG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%."}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1215', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in % Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.17', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '5.7', 'estimateComment': 'Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.', 'groupDescription': 'Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the percent of subjects temporarily or permanently changing their assigned therapy regimen due to an adverse event Week 0 to Week 6', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population of all randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.'}, {'id': 'FG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '186'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '183'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy\n\nDiscontinuation of hypertonic saline (HS): Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.'}, {'id': 'BG001', 'title': 'HS-Continue', 'description': "Continuation of current hypertonic saline (HS) therapy\n\nContinuation of hypertonic saline (HS): Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.8', 'spread': '11.06', 'groupId': 'BG000'}, {'value': '23.5', 'spread': '11.34', 'groupId': 'BG001'}, {'value': '22.7', 'spread': '11.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age Distribution (years)', 'categories': [{'title': '>=12 to 18', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}, {'title': '>=18 to <24', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': '>=24 to <30', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': '>=30', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaskan Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Other, More than one Race, or Unknown/Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cystic Fibrosis (CF) Genotype', 'classes': [{'categories': [{'title': 'F508 Homozygous', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}, {'title': 'F508 Heterozygous', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Other or Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Forced Expiratory Volume in 1 second (FEV1)', 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.91', 'groupId': 'BG000'}, {'value': '3.4', 'spread': '0.89', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '0.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Liters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1 (% Predicted) Distribution', 'classes': [{'categories': [{'title': '<60', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=60 to <70', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=70 to <90', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': '>=90 to <100', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': '>=100', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'FEV1 % predicted is calculated using the Global Lung Initiative multi-ethnic reference equations for ages 3-95.', 'unitOfMeasure': 'Participants'}, {'title': 'FEV1 (% Predicted)', 'classes': [{'categories': [{'measurements': [{'value': '97.6', 'spread': '17.55', 'groupId': 'BG000'}, {'value': '96.8', 'spread': '17.30', 'groupId': 'BG001'}, {'value': '97.2', 'spread': '17.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'FEV1 % predicted is calculated using the Global Lung Initiative multi-ethnic reference equations for ages 3-95.', 'unitOfMeasure': 'Percent of Predicted', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Current Dornase Alfa Use', 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Use as reported at screening prior to randomization', 'unitOfMeasure': 'Participants'}, {'title': 'Current Airway Clearance Use', 'classes': [{'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Includes airway clearance by route chest PT/vest.', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Enrollment in SIMPLIFY-DA Study', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Primary analyses were done on the per-protocol (PP) population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-14', 'size': 1258036, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-20T17:53', 'hasProtocol': True}, {'date': '2020-07-06', 'size': 1132069, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-20T17:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 370}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2024-04-01', 'resultsFirstSubmitDate': '2024-05-21', 'studyFirstSubmitQcDate': '2024-04-01', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-21', 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change in FEV1 % Predicted From Week 0 to Week 6', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the absolute change in FEV1 % predicted from Week 0 to Week 6.'}], 'secondaryOutcomes': [{'measure': 'Absolute Change in LCI 2.5 From Baseline to Week 6', 'timeFrame': 'Baseline (Week 0 or Week -2) to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the absolute change in LCI 2.5 (Lung Clearance Index) from Baseline (Week 0, if available, or else Week -2) to Week 6. LCI 2.5 is the number of times the volume in the lungs needs to turn over to expel an inert gas. A higher value of LCI 2.5 indicates poorer lung function.'}, {'measure': 'Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) From Week 0 to Week 6', 'timeFrame': 'Week 0 to Week 6', 'description': "Difference between study arms (discontinue - continue) in the absolute change in respiratory symptoms, as measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) from Week 0 to Week 6. The Cystic Fibrosis Respiratory Symptoms Daily Diary (CFRSD) asks a participant to state the extent of their 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms. Calculation of a score requires responses for at least 7 out of 8 symptoms."}, {'measure': 'Absolute Change in Respiratory Symptoms, as Measured by CFQ-R Respiratory Domain From Week 0 to Week 6', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the absolute change in respiratory symptoms, as measured by the Cystic Fibrosis Questionnaire-Revised Respiratory Domain Score from Week 0 to Week 6. The Cystic Fibrosis Questionnaire - Revised asks participants 6 questions related to respiratory symptoms which are each assigned a score 1-4. The Respiratory Domain Scaled Score is calculated as follows: 100\\*\\[{sum of responses}/{number of responses}-1\\]/3 only if number of responses ≥ 3; otherwise the score is set to missing. The scaled score ranges from 0 to 100 where higher scores indicate improvement of symptoms.'}, {'measure': 'Absolute Change in FEV1 % Predicted From Week -2 to Week 0', 'timeFrame': 'Week -2 to Week 0', 'description': 'Difference between study arms (discontinue - continue) in the absolute change in FEV1 % predicted from Week -2 to Week 0.'}, {'measure': 'Absolute Change in FEV1 % Predicted From Week 0 to Week 2', 'timeFrame': 'Week 0 to Week 2', 'description': 'Difference between study arms (discontinue - continue) in the absolute change in FEV1 % predicted from Week 0 to Week 2.'}, {'measure': 'Number and Percent of Participants Initiating Acute Antibiotics From Week 0 to Week 6', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the percent of subjects initiating acute oral, inhaled or intravenous antibiotics from Week 0 to Week 6. Includes antibiotics initiated for respiratory indications; excludes those taken as part of a chronic cycled regimen or for a UTI, skin infection, etc.'}, {'measure': 'Number and Percent of Participants Hospitalized From Week 0 to Week 6', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the percent of subjects hospitalized from Week 0 to Week 6.'}, {'measure': 'Number and Percent of Participants Experiencing Pulmonary Exacerbations From Week 0 to Week 6', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the percent of subjects experiencing a pulmonary exacerbation from Week 0 to Week 6. Pulmonary exacerbations defined using Fuchs criteria.'}, {'measure': 'Number and Percent of Participants Experiencing Adverse Events (AEs) From Week 0 to Week 6', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the percent of participants with at least one AE from Week 0 to Week 6. Includes serious and non-serious AEs.'}, {'measure': 'Rate of Adverse Events (AEs) From Week 0 to Week 6 Therapy Arms', 'timeFrame': 'Week 0 to Week 6', 'description': 'Comparison of study arms (discontinue/continue) in the rate of AE occurrence (number of events divided by total follow-up weeks in each arm) from Week 0 to Week 6. Includes serious and non-serious AEs.'}, {'measure': 'Number and Percent of Participants With Temporary or Permanent Changes From Assigned Therapy Regimen Due to Adverse Event From Week 0 to Week 6', 'timeFrame': 'Week 0 to Week 6', 'description': 'Difference between study arms (discontinue - continue) in the percent of subjects temporarily or permanently changing their assigned therapy regimen due to an adverse event Week 0 to Week 6'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystic Fibrosis', 'CF', 'Withdrawal', 'ETI', 'hypertonic saline', 'discontinue'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline in those people that are also taking elexacaftor/tezacaftor/ivacaftor (ETI).\n\nETI is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up ETI work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function.\n\nInhaled hypertonic saline (HS) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. HS is considered to be relatively burdensome and it is not known whether HS can improve or maintain lung function above what is already gained through ETI use.\n\nThe goal of this SIMPLIFY sub-study is to get information about whether or not it is safe to stop hypertonic saline by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking HS as compared to those who are assigned to keep taking HS while continuing to take ETI.\n\nThis is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153.\n\nThe sub study investigating the impact of discontinuing and continuing dornase alfa is registered under NCTXXXXXXX (will add once available).', 'detailedDescription': "This SIMPLIFY sub-study (Hypertonic Saline (HS) Trial) is designed to evaluate the effects of discontinuing HS in people with cystic fibrosis (CF) age 12 and older currently taking the highly effective modulator elexacaftor/tezacaftor/ivacaftor (ETI). This is an open label two-arm randomized non-inferiority trial consisting of a 2-week screening period, randomization to continue or discontinue hypertonic saline, followed by a 6-week study period. Participants at trial entry will be randomized 1:1 to either continue or discontinue their HS therapy.\n\nClinical outcomes (forced expiratory volume in 1 second \\[FEV1\\], antibiotic use, pulmonary exacerbations, and patient reported outcomes), safety (adverse events) and patient reported outcomes to evaluate respiratory symptoms and the participant's perception of how stopping HS would impact their daily life will be evaluated in all subjects. Additionally, a subset of participants at selected study sites will participate in Multiple Breath Washout (MBW) to evaluate changes in lung clearance index (LCI)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of CF.\n* Age ≥ 12 years at the Screening Visit.\n* Forced expiratory volume in 1 second (FEV1) ≥ 70 % predicted at the Screening Visit if \\< 18 years old, and ≥ 60 % predicted at Screening Visit if ≥ 18 years old.\n* Clinically stable with no significant changes in health status within the 7 days prior to and including the Screening Visit.\n* Current treatment with elexacaftor/tezacaftor/ivacaftor (ETI) for at least the 90 days prior to and including the Screening Visit and willing to continue daily use for the duration of the study.\n* Currently taking hypertonic saline (at least 3%) for at least the 90 days prior to and including the Screening Visit and willing to continue daily use for the 2-week screening period.\n\nExclusion Criteria:\n\n* Active smoking or vaping.\n* Use of an investigational drug within 28 days prior to and including the Screening Visit.\n* Changes to chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, aztreonam lysine) within 28 days prior to and including the Screening Visit. This includes new airway clearance routines.\n* Acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 7 days prior to and including the Screening Visit.\n* Chronic use of systemic corticosteroids at a dose equivalent to ≥ 10mg per day of prednisone within 28 days prior to and including the Screening Visit.\n* Antibiotic treatment for nontuberculous mycobacteria (NTM) within 28 days prior to and including the Screening Visit.'}, 'identificationModule': {'nctId': 'NCT06350461', 'acronym': 'SIMPLIFY-HS', 'briefTitle': 'Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-Study', 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': 'A Master Protocol to Test the Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy - Hypertonic Saline', 'orgStudyIdInfo': {'id': 'SIMPLIFY-IP-19 HS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HS-Discontinue', 'description': 'Discontinuation of current hypertonic saline (HS) therapy', 'interventionNames': ['Other: Discontinuation of hypertonic saline (HS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HS-Continue', 'description': 'Continuation of current hypertonic saline (HS) therapy', 'interventionNames': ['Other: Continuation of hypertonic saline (HS)']}], 'interventions': [{'name': 'Discontinuation of hypertonic saline (HS)', 'type': 'OTHER', 'description': 'Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.', 'armGroupLabels': ['HS-Discontinue']}, {'name': 'Continuation of hypertonic saline (HS)', 'type': 'OTHER', 'description': "Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%.", 'armGroupLabels': ['HS-Continue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Providence Alaska Medical Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Cystic Fibrosis Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90806', 'city': 'Long Beach', 'state': 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[{'name': 'Cystic Fibrosis Foundation', 'class': 'OTHER'}, {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics, Division of Pulmonary and Sleep Medicine, University of Washington School of Medicine Adjunct Professor, Biostatistics, University of Washington School of Medicine Co-Executive Director, Cystic Fibrosis Therapeutics Development', 'investigatorFullName': 'Nicole Hamblett', 'investigatorAffiliation': "Seattle Children's Hospital"}}}}