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NCT04059094 · ClinicalTrials.gov registry record · Phase 2
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 Phase 2 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT04059094: Clinical Trial Phase 2 study, sponsored by Boehringer Ingelheim.
NCT04059094 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04059094, a Phase 2 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study 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.
Primary Outcome
Trough FEV1 was measured within 30 minutes prior to dosing of study medication.
Interventions
- DRUG Placebo
- DRUG BI 1265162
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2020-04-24 |
| Phase | Phase 2 |
Why NCT04059094 stopped before completion
NCT04059094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04059094 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04059094 about?
NCT04059094 is a clinical study titled "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". 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.
What is the current status of trial NCT04059094?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2019-09-16. Estimated completion is 2020-04-24.
What interventions are being tested in trial NCT04059094?
The interventions under investigation include: Placebo (DRUG), BI 1265162 (DRUG).
Who is sponsoring clinical trial NCT04059094?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04059094's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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