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NCT01397201 · ClinicalTrials.gov registry record · Phase 2
Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Low Dose Inhaled Corticosteroid (ICS)
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01397201: Clinical Trial Phase 2 study, sponsored by Boehringer Ingelheim.
NCT01397201 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01397201, a Phase 2 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses twice daily (b.i.d.), fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI) at a dose of 220 mcg b.i.d. and placebo b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on low dose Inhaled corticosteroid (ICS) as demonstrated by a decrease in forced expiratory volume in one second (FEV1 (range 10-25%) and an asthma control questionnaire (ACQ-6) greater or equal 1.5 at time of randomisation
Primary Outcome
Mean change from randomisation baseline to the end of the 8-week treatment period in trough (pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1).
Interventions
- DRUG Placebo
- DRUG Fluticasone propionate
- DRUG BI 54903
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-07-01 |
| Est. Completion | 2011-12-23 |
| Phase | Phase 2 |
Why NCT01397201 stopped before completion
NCT01397201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01397201 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01397201 about?
NCT01397201 is a clinical study titled "Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Low Dose Inhaled Corticosteroid (ICS)". The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses twice daily (b.i.d.), fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI) at a dose of 220 mcg b.i.d. and placebo b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 ye...
What is the current status of trial NCT01397201?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2011-07-01. Estimated completion is 2011-12-23.
What interventions are being tested in trial NCT01397201?
The interventions under investigation include: Placebo (DRUG), Fluticasone propionate (DRUG), BI 54903 (DRUG).
Who is sponsoring clinical trial NCT01397201?
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 NCT01397201's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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