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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?

University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,280,004 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,310,595 Total Patients Enrolled
Vertex Pharmaceuticals IncorporatedIndustry Sponsor
243 Previous Clinical Trials
32,347 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to partake in this research endeavor?

"Applicants for this clinical trial should suffer from chronic bronchitis, and be within the 40-80 year old range. Approximately 40 individuals will receive admission to the study."

Answered by AI

In what circumstances is Ivacaftor typically administered?

"Ivacaftor has been formulated to treat an ivacaftor-responsive cftr mutation, homozygous for f508del mutation in the cftr gene and cystic fibrosis (cf)."

Answered by AI

Does this research project offer any innovative insights?

"Since it's inception in 2015, Ivacaftor has been subject to multiple clinical trials. The initial research was conducted by Vertex Pharmaceuticals Incorporated and involved 1044 participants. On the back of positive Phase 3 results, there are now 21 ongoing studies being run across 23 countries and 109 cities worldwide."

Answered by AI

Can you summarize the primary aims of this investigation?

"This study will assess the safety of ivacaftor by examining abnormal serum chemistry from Screening to Day 98 as its primary objective. Secondary objectives include measuring respiratory function with post-bronchodilator spirometry and assessing patient wellbeing through San Diego Shortness of Breath Questionnaire (SOBQ) and St. George Respiratory Questionnaire (SGRQ), both of which have a Minimum Clinically Important Difference (MCID) score of 5 and 4 respectively."

Answered by AI

Is there still availability for participants in this trial?

"According to the information hosted online at clinicaltrials.gov, this trial is actively seeking participants that meet its criteria. It was first posted on March 16th 2017 and most recently modified on March 24th 2022."

Answered by AI

Could you provide information regarding any other investigations conducted with Ivacaftor?

"At present, 21 medical studies are underway to assess Ivacaftor's efficacy. Of those trials, 14 occupy Phase 3 while the remainder of investigations occur at 1015 sites across Bochum and California."

Answered by AI

Does this research encompass geriatric participants?

"This trial includes individuals aged 40 or older, but not exceeding 80 years in age."

Answered by AI

Has the FDA sanctioned Ivacaftor for medical use?

"Ivacaftor is believed to be relatively safe but efficacy has not been fully explored, so it scored a 2 on Power's scale of 1-3."

Answered by AI

How many individuals are currently eligible for this experiment?

"Affirmative, information from clinicaltrials.gov reveals that the clinical trial is still enrolling participants. First posted on March 16th 2017 and most recently updated on March 24th 2022, this medical experiment requires 40 individuals to be recruited at a single site."

Answered by AI
~5 spots leftby Apr 2025