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TOPIC Trial for COPD

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ClinicalTrials.gov Identifier: NCT02135432
Recruitment Status : Completed
First Posted : May 12, 2014
Results First Posted : February 24, 2017
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Steven M Rowe, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE April 15, 2014
First Posted Date  ICMJE May 12, 2014
Results First Submitted Date  ICMJE May 25, 2016
Results First Posted Date  ICMJE February 24, 2017
Last Update Posted Date February 24, 2017
Study Start Date  ICMJE May 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • Change in COPD as measured by lung function [ Time Frame: baseline to 6 months ]
    Evaluate the efficacy of ivacaftor treatment in patients with COPD including measures of CFTR activity and clinical outcome as measured by change in lung function
  • Change in COPD as measured bysweat analysis [ Time Frame: baseline and 6 months ]
    Evaluate the efficacy of ivacaftor treatment in patients with COPD including measures of CFTR activity and clinical outcome as measured by change sweat analysis.
  • change in COPD as measured by nasal potential difference measurements [ Time Frame: baseline to 6 months ]
    Evaluate the efficacy of ivacaftor treatment in patients with COPD including measures of CFTR activity and clinical outcome as measured by change nasal potential difference measurements
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
Mean number of adverse events experienced by the Ivacaftor subjects and placebo subjects. [ Time Frame: baseline through 6 months (visit 5) ]
mean number of adverse events per subject in each the Ivacaftor subjects and placebo subjects
Current Other Pre-specified Outcome Measures
 (submitted: January 5, 2017)
Pharmacokinetics as Described by AUC12 of Subjects Receiving Ivacaftor [ Time Frame: baseline to 2 weeks ]
Original Other Pre-specified Outcome Measures
 (submitted: May 8, 2014)
Pharmacokinetics as described by AUC12 of subjects receiving ivacaftor [ Time Frame: at 6 months post baseline ]
 
Descriptive Information
Brief Title  ICMJE TOPIC Trial for COPD
Official Title  ICMJE 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)
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: Ivacaftor
    Other Name: Kalydeco
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Ivacaftor (VX-770)
    twice a day administration of Ivacaftor: 150mg
    Intervention: Drug: Ivacaftor
  • Placebo Comparator: Placebo
    matching placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2014)
12
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2014)
9
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135432
Other Study ID Numbers  ICMJE F140319002
TOPIC Trial ( Other Identifier: UAB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Steven M Rowe, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alabama at Birmingham
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP