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RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative

NCT02867761 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2023-04-13

Study results available
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Summary

The study hypothesis is that symptomatic current and former smokers with spirometric values within the normal range (post-bronchodilator FEV1/FVC≥0.70 and post-BD FVC ≥ 70% predicted will still derive symptomatic benefit from long-acting bronchodilator therapy even though they are excluded from current GOLD guideline recommendations.

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)

Interventions

DRUG

Indacaterol/Glycopyrrolate

27.5/15.6 mcg active indacaterol/glycopyrrolate

DRUG

Placebo

27.5/15.6 mcg placebo

Sponsors & Collaborators

Principal Investigators

  • MeiLan Han, MD, MS · University of Michigan

  • Prescott Woodruff, MD, MPH · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-29
Primary Completion
2021-07-07
Completion
2021-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02867761 on ClinicalTrials.gov