Trials / Completed
CompletedNCT02676076
TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA
A 52 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 2-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 100/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 100/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) IN PATIENTS WITH ASTHMA UNCONTROLLED ON MEDIUM DOSES OF INHALED CORTICOSTEROIDS IN COMBINATION WITH LONG ACTING ß2 AGONISTS
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,153 (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 CHF 5993 100/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronum bromide) versus CHF 1535 100/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate), in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CHF 5993 100/6/12.5 µg | |
| DRUG | CHF 1535 100/6 µg |
Timeline
- Start date
- 2016-02-17
- Primary completion
- 2018-05-17
- Completion
- 2018-05-17
- First posted
- 2016-02-08
- Last updated
- 2021-04-08
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02676076. Inclusion in this directory is not an endorsement.