Early Phase 1
Completed N=12
TOPIC Trial for COPD
Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT02135432 ↗
Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Feb 2017
Primary outcomePrimary: Change in COPD as Measured by the Sweat Analysis in Each Group — -8.0; 2.0 mmol/L
Summary
The study is a randomized, double-blind, placebo-controlled, multiple-dose, pilot study of orally-administered ivacaftor in subjects with chronic obstructive pulmonary disease. Subjects will be administered the study drug ivacaftor 150 mg (or placebo) twice daily (BID).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in COPD as Measured by the Sweat Analysis in Each Group |
-8.0; 2.0 | — |
| SECONDARY Change in COPD as Measured by Nasal Potential Difference |
-4.9; 1.0 | — |
| SECONDARY Number of Adverse Events Experienced by the Ivacaftor Subjects and Placebo Subjects. |
22; 14 | — |
| SECONDARY Change in COPD as Measured by Change in Percentage of FEV1 as Measured in Each Group |
-2.3; 1.8 | — |
Eligibility Criteria
Inclusion Criteria
- Male or Female age 40-65
- A clinical diagnosis of COPD as defined by GOLD
- At Least a 10 pack year smoking history
- Exhibit symptoms of chronic bronchitis defined by MRC
- FEV1% predicted ≥ 35% and ≤70% Post Bronchodilator
- Clinically stable in the last 4 weeks with no evidence of COPD exacerbation
- Weight of 40 kg-120 kg
- Willingness to use at least one form of acceptable birth control including abstinence, condom with spermicide, or hormonal contraceptives
- Willing to monitor blood glucose if known history of diabetes mellitus requiring insulin or medical therapy
Exclusion Criteria
- Current Diagnosis of Asthma
- Daytime use of Oxygen Therapy
- Documented history of drug abuse within the last year
- Subjects should not have a pulmonary exacerbation or changes in therapy for pulmonary disease within 28 days before receiving the first dose of study drug.
- Cirrhosis or elevated liver transaminases > 3X ULN
- GFR 5years))except for localized non-melanomatous skin cancers History of Stroke/CVA History of myocardial infarction/acute coronary syndrome Cardiac Failure NYHC grade III-IV Diabetes Type I Uncontrolled Hypertension Primary or secondary pulmonary hypertension
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Data sourced from ClinicalTrials.gov (NCT02135432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.