NCT04441788

A Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Participants With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis (CB)

A Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Patients With Mild to Moderate COPD With Chronic Bronchitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the effect of ION-827359 on forced expiratory volume in 1 second (FEV1) in participants with mild to moderate COPD with CB.

Detailed description

This was a multi-center, double-blind, placebo-controlled, randomized, Phase 2a study of ION-827359 in up to 180 participants. The participants were randomized to receive oral inhalation of either ION-827359 or placebo for up to 13 weeks. At the end of 13 weeks, participants entered a 10-week post-treatment evaluation period.

Conditions

• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	ION-827359	ION-827359 administered by oral inhalation
DRUG	Placebo	Placebo administered by oral inhalation
DRUG	ION-827359	ION-827359 administered by oral inhalation

Timeline

• Start date: 2020-12-22
• Primary completion: 2021-04-27
• Completion: 2021-08-09
• First posted: 2020-06-22
• Last updated: 2022-12-20
• Results posted: 2022-12-20

Locations

15 sites across 4 countries: Czechia, Germany, Hungary, United Kingdom

Regulatory

• FDA-regulated drug study