Trials / Completed
CompletedNCT02296411
Efficacy of LAMA Added to ICS in Treatment of Asthma
A Multicentre, Randomised, Double-blind, Placebo-controlled, 2-way Cross-over Study to Evaluate the Efficacy and Safety of CHF 5259 (Glycopyrrolate Bromide) pMDI on Top of QVAR® pMDI for the Treatment of Patients With Uncontrolled Asthma on Low-Medium Dose of Inhaled Corticosteroids
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 98 (actual)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the superiority of the glycopyrrolate bromide (CHF 5259 pMDI) versus placebo on top of QVAR® pMDI, in terms of lung functions parameters, as well as to assess its safety.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CHF 5259 12.5 µg | comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks |
| DRUG | CHF 5259 placebo | comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2014-11-20
- Last updated
- 2021-04-08
Locations
28 sites across 5 countries: Bulgaria, Germany, Italy, Netherlands, Poland
Source: ClinicalTrials.gov record NCT02296411. Inclusion in this directory is not an endorsement.