Trials / Completed
CompletedNCT05097014
CHF5993 and CHF1535 pMDI on Lung Hyperinflation and Exercise Endurance Time in Subjects With COPD
A Double Blind, Multicentre, Randomised, Placebo-Controlled, 3-Way Cross-Over Study To Evaluate The Effect Of A Triple Combination Of Beclometasone Dipropionate And Formoterol Fumarate Plus Glycopyrronium (CHF5993) And A Dual Combination Of Beclometasone Dipropionate Plus Formoterol Fumarate (CHF1535) Both Administered Via pMDI On Lung Hyperinflation And Exercise Endurance Time In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
Double Blind, Multinational, Multicentre, Randomised, Placebo-Controlled, 3-Way Cross-Over Study To Evaluate The Effect Of A Triple Combination Of Beclometasone Dipropionate And Formoterol Fumarate Plus Glycopyrronium (CHF5993) And A Dual Combination Of Beclometasone Dipropionate Plus Formoterol Fumarate (CHF1535) Both Administered Via pMDI On Lung Hyperinflation And Exercise Endurance Time In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CHF5993 | Pressurized metered dose inhaler (pMDI) 2 inhalations bid |
| DRUG | CHF1535 | Pressurized metered dose inhaler (pMDI) 2 inhalations bid |
| OTHER | Matched placebo | Pressurized metered dose inhaler (pMDI) 2 inhalations bid |
Timeline
- Start date
- 2021-10-28
- Primary completion
- 2023-02-24
- Completion
- 2023-02-24
- First posted
- 2021-10-27
- Last updated
- 2023-03-24
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05097014. Inclusion in this directory is not an endorsement.