TOPIC Trial for COPD

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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).

Key facts

Study ID

NCT02135432

Run by

University of Alabama at Birmingham

People needed

12

Starts

2015-05-01

Expected to finish

2015-11-01

Last updated by the study team

2017-02-24

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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