A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD

Official title

A Phase III, 52-week, Multinational, Multicenter, Randomized, Double-blind, 2-arm Parallel Group Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide (CHF 5993) With the Fixed Dose Dual Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate (CHF 1535), Both Administered Via pMDI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Study identification

NCT ID

NCT04320342

Recruitment status

Completed

Study type

Interventional

Phase

Phase 3

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Enrollment

3,406 participants

Conditions and interventions

Eligibility (public fields only)

Age range

40 Years and older

Sex

All

Healthy volunteers

Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date

Apr 27, 2022 (Actual)

Primary completion

Jan 12, 2026 (Actual)

Completion

Jan 12, 2026 (Actual)

Last update posted

Sep 21, 2026

2022 – 2026

United States locations

U.S. sites

276

U.S. states

36

U.S. cities

181

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 160 non-U.S. sites.