- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02135432
TOPIC Trial for COPD
A Randomized, Double-Blind, Placebo Controlled Pilot Study to Determine the Safety and Efficacy of Ivacaftor (VX-770) for the Treatment of Chronic Obstructive Pulmonary Disease (The TOPIC Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 < 50 estimated by Cockcroft-Gault
- Any illness of abnormal lab finding that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug to the subject.
- Pregnant or Breastfeeding
- Subjects taking any inhibitors or inducers of CYP3A4, including certain herbal medications and grapefruit/grapefruit juice.
- Uncontrolled Diabetes
- Excluded medications and foods include the drugs and foods provided in the appendix document.
- Clinically significant arrhythmias or conduction abnormalities that in the opinion of the investigator affect patient safety have been added as exclusion criteria and criteria for withdrawal.
Patients who have not been stable or have been hospitalized in the past 3 months with any clinically significant cardiac conditions.
Subjects with history of cancer (current or past, unless remote (>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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
matching placebo
|
|
Experimental: Ivacaftor (VX-770)
twice a day administration of Ivacaftor: 150mg
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in COPD as Measured by the Sweat Analysis in Each Group
Time Frame: baseline to 2 weeks
|
sweat analysis is measured by performing a sweat test in each participant.
The primary analysis will compare the within group change in sweat chloride before (day 1) and after (day 14) ivacaftor or placebo administration and will be used to test the null hypothesis of no change in sweat chloride using a paired t-test unless the distributions are notably skewed, in which case the non-parametric Wilcoxon signed-rank test will be implemented due to small sample size.
|
baseline to 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in COPD as Measured by Nasal Potential Difference
Time Frame: baseline to 2 weeks
|
Evaluate the efficacy of ivacaftor treatment in patients with COPD including measures of CFTR activity and clinical outcome as measured by change in nasal potential difference measurement in each group.
These data will be used to test the null hypothesis of no change in nasal potential difference (ΔLow Chloride plus isoproterenol) using a paired t-test unless the distributions are notably skewed, in which case the non-parametric Wilcoxon signed-rank test will be implemented due to small sample size.
|
baseline to 2 weeks
|
Number of Adverse Events Experienced by the Ivacaftor Subjects and Placebo Subjects.
Time Frame: baseline to 2 weeks
|
Number of adverse events per subject in each the Ivacaftor subjects and placebo subjects
|
baseline to 2 weeks
|
Change in COPD as Measured by Change in Percentage of FEV1 as Measured in Each Group
Time Frame: baseline to 2 weeks
|
Spirometry will be analyzed by ATS criteria, and the best of three reproducible efforts will be used to calculate FEV1 in comparison to Hankinson standards.
The primary analysis will be the change in FEV1% from day 0 to day 14 within subject, and will be tested against the null hypothesis that no change occurs using a paired t-test unless the distributions are notably skewed, in which case the non-parametric Wilcoxon signed-rank test will be implemented due to small sample size.
|
baseline to 2 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics as Described by AUC12 of Subjects Receiving Ivacaftor
Time Frame: baseline to 2 weeks
|
baseline to 2 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F140319002
- TOPIC Trial (Other Identifier: UAB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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