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CFTR Potentiator

Ivacaftor for Chronic Obstructive Pulmonary Disease

Phase 2
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from d1 to day 84
Awards & highlights

Study Summary

This trial is testing a drug called Ivacaftor to see if it is safe and effective for treating COPD, chronic bronchitis, and other CFTR-related disorders. The study is small, with only 40 patients, and is double-blind, meaning that neither the patients nor the doctors will know who is receiving the drug or the placebo.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Chronic Bronchitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from d1 to day 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and from d1 to day 84 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of Ivacaftor - Number of Participants With Abnormal ECG (Prolonged QT Intervals)
Safety of Ivacaftor - Number of Participants With Abnormal Hematology
Safety of Ivacaftor - Number of Participants With Abnormal Serum Chemistry
+1 more
Secondary outcome measures
Breathlessness, Cough, and Sputum Scale (BCSS)
COPD Assessment Test (CAT)
Central CFTR Activity Measured by Mucociliary Clearance (MCC) Percentage Clearance at 60 Mins
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: IvacaftorActive Control1 Intervention
Ivacaftor, 150 mg PO every 12 hrs for 84 days
Group II: PlaceboPlacebo Group1 Intervention
matching placebo

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedIndustry Sponsor
246 Previous Clinical Trials
32,542 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,594 Previous Clinical Trials
2,282,429 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,818,196 Total Patients Enrolled
~5 spots leftby May 2025
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