Trials / Terminated
TerminatedNCT04059094
A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1
A Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Evaluate Efficacy and Safety of Twice Daily Inhaled Doses of BI 1265162 Delivered by Respimat® Inhaler as add-on Therapy to Standard of Care Over 4 Weeks in Patients With Cystic Fibrosis - BALANCE - CF™ 1
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this trial is to assess the efficacy, safety and pharmacokinetics of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler versus placebo in adolescents and adult patients with cystic fibrosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 1265162 | Inhalation solution |
| DRUG | Placebo | Inhalation solution |
Timeline
- Start date
- 2019-09-16
- Primary completion
- 2020-04-16
- Completion
- 2020-04-24
- First posted
- 2019-08-16
- Last updated
- 2021-06-04
- Results posted
- 2021-06-04
Locations
26 sites across 8 countries: United States, Belgium, Canada, France, Germany, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04059094. Inclusion in this directory is not an endorsement.