TOPIC Trial for COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135432
• Other study ID #: F140319002
• Secondary ID: TOPIC Trial
• Status: Completed
• Phase: Phase 0
• First received: April 15, 2014
• Last updated: November 30, 2015
• Start date: May 2015
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Ivacaftor

• Placebo

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetics as described by AUC12 of subjects receiving ivacaftor		baseline to 2 weeks	Yes
Primary	Change in COPD as measured by Nasal potential difference	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	baseline to 2 weeks	No
Secondary	Mean number of adverse events experienced by the Ivacaftor subjects and placebo subjects.	mean number of adverse events per subject in each the Ivacaftor subjects and placebo subjects	baseline to two weeks	No
Secondary	Change in COPD as measured by sweat analysis		baseline to 2 weeks	No
Secondary	change in COPD as measured by lung function		baseline to 2 weeks	No