Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03085485 · ClinicalTrials.gov registry record · Phase 2

The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftor

A Phase 2 study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT03085485 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 40 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03085485, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

The study is a Phase 2 Study to establish the safety and efficacy of a drug called Ivacaftor (VX-770) in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis, and acquired CFTR dysfunction as detected by sweat chloride analysis. The design is a pilot, randomized (3:1, active:placebo), double-blind, placebo-controlled study. Approximately 40 subjects with COPD will be randomized.

Interventions

  • DRUG Placebo
  • DRUG Ivacaftor 150 MG

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2017-03-16
Est. Completion 2022-09-30
Phase Phase 2

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT03085485

The ClinicalTrials.gov registry entry for NCT03085485 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03085485 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03085485 about?

NCT03085485 is a clinical study titled "The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftor". The study is a Phase 2 Study to establish the safety and efficacy of a drug called Ivacaftor (VX-770) in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis, and acquired CFTR dysfunction as detected by sweat chloride analysis. The design is a pilot, randomized (3:1, activ...

What is the current status of trial NCT03085485?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2017-03-16. Estimated completion is 2022-09-30.

What interventions are being tested in trial NCT03085485?

The interventions under investigation include: Placebo (DRUG), Ivacaftor 150 MG (DRUG).

Who is sponsoring clinical trial NCT03085485?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.