NCT02867761

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 780 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

RETHINC is a 12-week multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily in symptomatic current and former smokers with respiratory symptoms despite preserved spirometry as defined by CAT ≥ 10 and post-bronchodilator FEV1/FVC ratio ≥0.70, respectively.

Conditions

• COPD (Chronic Obstructive Pulmonary Disease)

Interventions

Type	Name	Description
DRUG	Indacaterol/Glycopyrrolate	27.5/15.6 mcg active indacaterol/glycopyrrolate
DRUG	Placebo	27.5/15.6 mcg placebo

Timeline

• Start date: 2017-08-29
• Primary completion: 2021-07-07
• Completion: 2021-07-07
• First posted: 2016-08-16
• Last updated: 2023-04-13
• Results posted: 2022-08-30

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study