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NCT01397162 · ClinicalTrials.gov registry record · Phase 2
Dose Finding Study on BI54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat® Inhaler in Asthmatic Patients Inadequately Controlled on Short-acting-beta-agonist (SABA) Therapy
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT01397162 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 29 participants.
The verdict
NCT01397162, a Phase 2 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 29 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.) and fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI) at a dose of 88 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 short-acting-beta-agonist (SABA) prn therapy only as demonstrated by a decrease in forced expiratory volume in one second (FEV1) range10 to 25% and an asthma control questionnaire (ACQ-6) equal or greater than 1.5 at time of randomization
Interventions
- DRUG Placebo
- DRUG Fluticasone propionate
- DRUG BI 54903
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2011-07-21 |
| Est. Completion | 2011-12-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01397162
The ClinicalTrials.gov registry entry for NCT01397162 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 29 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.
NCT01397162 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01397162 about?
NCT01397162 is a clinical study titled "Dose Finding Study on BI54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat® Inhaler in Asthmatic Patients Inadequately Controlled on Short-acting-beta-agonist (SABA) Therapy". The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses twice daily (b.i.d.) and fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI) at a dose of 88 mcg b.i.d and placebo b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 y...
What is the current status of trial NCT01397162?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2011-07-21. Estimated completion is 2011-12-23.
What interventions are being tested in trial NCT01397162?
The interventions under investigation include: Placebo (DRUG), Fluticasone propionate (DRUG), BI 54903 (DRUG).
Who is sponsoring clinical trial NCT01397162?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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