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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 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 30 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01397201
The ClinicalTrials.gov registry entry for NCT01397201 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01397201 reports 0 study locations.
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.
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