CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 750 enrolled
Drug / intervention
CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo +1 moredrug
Likely dose
CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebofrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03888131
NCT03888131Phase 3Completed
CompareCT.gov

A 24-week, Double Blind, Double Dummy, Randomized, Multicentre, 2-arm Parallel Group, Active Controlled Clinical Trial of Fixed Combination of Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI (CHF 1535) Versus the Fixed Combination of Budesonide Plus Formoterol Fumarate (Symbicort® Turbohaler®) in Patients With Chronic Obstructive Pulmonary Disease

Chiesi Farmaceutici S.p.A.·interventional·Posted Mar 25, 2019·Updated May 12, 2026

In Brief

A Phase 3 clinical trial evaluating CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo and Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo for Chronic Obstructive Pulmonary Disease. Completed, enrolled 750 participants across 53 sites.

Detailed Summary

Primary Objective To demonstrate that CHF 1535 pMDI is non-inferior to Symbicort® Turbohaler® in terms of pulmonary function (change from baseline in pre-dose morning FEV1 at Week 24) in patients with COPD. Secondary Objectives * To evaluate the effect of CHF 1535 pMDI on other lung function parameters, and patient reported outcomes (PROs); * To assess the safety and the tolerability of the study treatments.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMar 25, 2019
Enrollment StartJul 30, 2018
Primary CompletionMay 6, 2022
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.3 years ago

Interventions

CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebodrug

2 inhalations BID Total Daily Dose = 400/24µg

Symbicort® Turbohaler® plus CHF 1535 pMDI Placebodrug

2 inhalations BID Total Daily Dose = 640/18µg