Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	Safety of Ivacaftor - Number of Participants With Adverse Events	From Screening to Day 98	Safety of ivacaftor will be determined by number of participants with adverse events (including serious adverse events).
Primary	Safety of Ivacaftor - Number of Participants With Abnormal Serum Chemistry	From Screening to Day 98	Number of participants with abnormal serum chemistry values compared to screening values will also be used to determine safety of ivacaftor.
Primary	Safety of Ivacaftor - Number of Participants With Abnormal Hematology	From Screening to Day 98	Safety of ivacaftor will also be determined by number of participants with abnormal changes in their screening hematology values.
Primary	Safety of Ivacaftor - Number of Participants With Abnormal ECG (Prolonged QT Intervals)	From Screening to Day 98	Number of participants with abnormal changes in their screening ECGs is another factor that will be used to evaluate the safety of ivacaftor.
Secondary	Central CFTR Activity Measured by Mucociliary Clearance (MCC) Percentage Clearance at 60 Mins	From Screening to Day 84	Clearance of Tc99 sulfur colloid is a measure of MCC of the lungs, and is calculated by a standard protocol developed by the Cystic Fibrosis Therapeutics Development Network. The method provides a robust measure of MCC, and has been sensitive to the effects of inhaled pharmacologic agents in CF and COPD including improvements of an unprecedentedly large magnitude in CF patients with the G551D-CFTR mutation treated with ivacaftor measured in a multicenter study. The technique allows estimates of MCC in both the small and large airway compartments.
Secondary	Peripheral CFTR Activity Measured by Change in Sweat Chloride	From Screening to Day 84	Sweat chloride abnormality is correlated with COPD severity and symptoms, and is a highly sensitive outcome measure for CFTR-directed therapeutics. We have shown sweat chloride is sensitive to the presence of cigarette smoking and COPD, and the test has been successfully used as an endpoint in multiple CF trials, including studies to detect the efficacy of ivacaftor therapy.
Secondary	Indicators of Respiratory Function and COPD Health : Change in FEV1 Predict %	From Screening to Day 84	Spirometry is a standard outcome measure in COPD and a major indicator of efficacy and safety in COPD clinical trials. Post-bronchodilator spirometry will be performed by ATS criteria. FEV1 will be measured in predict percentage.
Secondary	San Diego Shortness of Breath Questionnaire (SOBQ)	From D1 to Day 84	The SOBQ is a self-reported questionnaire that assesses shortness of breath while performing a variety of activities of daily living. The Minimum Clinically Important Difference (MCID) is 5. The SOBQ includes 24 items, using 6-point scale with 0 = "not at all" to 5 = "maximal or unable to do because of breathlessness". The sum of SOBQ score ranges from 0 to 120, with higher score indicating more breathlessness.
Secondary	Breathlessness, Cough, and Sputum Scale (BCSS)	From D1 to Day 84	The BCSS is a three-item questionnaire rating breathlessness, cough and sputum on a 5-point Likert scale from 0 (no symptoms) to 4 (severe symptoms). The BCSS score ranges from 0 to 12; the higher the score indicates the worse of symptoms.
Secondary	COPD Assessment Test (CAT)	From D1 to Day 84	CAT is a self-reported questionnaire that measures COPD related quality of life. The MCID is 2. CAT composes of 8 questions, and the scores range from 0 - 40. Higher scores denote a more severe impact of COPD on a patient's life.
Secondary	St. George Respiratory Questionnaire (SGRQ)	From D1 to Day 84	The SGRQ is a disease-specific measure of health status for use in COPD with an MCID of 4. The scores range from 0 to 100, with higher scores indicating more limitations.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this list from software.

Twenty rows a page, as JSON. No key.

GET https://conductscience.org/api/trials/v1/NCT03085485/registered

API reference For AI assistants