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NCT01396278 · 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 Medium Dose Inhaled Corticosteroid (ICS).
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT01396278 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 9 participants.
The verdict
NCT01396278, a Phase 2 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
The aim of the study is to assess and compare efficacy and safety of BI 54903 at three different dosages (b.i.d)., fluticasone propionate hydrofluoroalkane (HFA) metered dose inhaler (MDI) at a dose of 440 mcg b.i.d and low dose fluticasone propionate 88 mcg b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled medium dose ICS therapy as demonstrated by a decrease in forced expiratory volume in one second (FEV1) range 10 to 25 % and an asthma control questionnaire-6 (ACQ-6) equal or greater than 1.5 at time of randomisation.
Interventions
- DRUG Placebo
- DRUG Fluticasone propionate
- DRUG BI 54903
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-07-01 |
| Est. Completion | 2011-12-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01396278
The ClinicalTrials.gov registry entry for NCT01396278 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 9 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.
NCT01396278 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01396278 about?
NCT01396278 is a clinical study titled "Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Medium Dose Inhaled Corticosteroid (ICS).". The aim of the study is to assess and compare efficacy and safety of BI 54903 at three different dosages (b.i.d)., fluticasone propionate hydrofluoroalkane (HFA) metered dose inhaler (MDI) at a dose of 440 mcg b.i.d and low dose fluticasone propionate 88 mcg b.i.d. over an 8-week treatment period in...
What is the current status of trial NCT01396278?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2011-07-01. Estimated completion is 2011-12-14.
What interventions are being tested in trial NCT01396278?
The interventions under investigation include: Placebo (DRUG), Fluticasone propionate (DRUG), BI 54903 (DRUG).
Who is sponsoring clinical trial NCT01396278?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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