Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Medium Dose Inhaled Corticosteroid (ICS).
Public ClinicalTrials.gov record NCT01396278. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomised, Double-blind, Double-dummy, Active-controlled, Parallel-group Study to Assess and Compare Efficacy and Safety of an 8-week Treatment With BI 54903 at Doses of 90.9, 181.8 and 363.6 µg b.i.d. Administered Via Respimat® Inhaler and Fluticasone Propionate HFA MDI 440 µg b.i.d. in Patients With Asthma Inadequately Controlled on Medium Dose ICS Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01396278
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 9 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 1, 2011 (Actual)
- Primary completion
- Dec 1, 2011 (Actual)
- Completion
- Dec 14, 2011 (Actual)
- Last update posted
- Feb 7, 2025
2011
United States locations
- U.S. sites
- 37
- U.S. states
- 21
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1248.7.01047 Boehringer Ingelheim Investigational Site | Fountain Valley | California | — | — |
| 1248.7.01023 Boehringer Ingelheim Investigational Site | Fullerton | California | — | — |
| 1248.7.01038 Boehringer Ingelheim Investigational Site | Long Beach | California | — | — |
| 1248.7.01004 Boehringer Ingelheim Investigational Site | Mission Viejo | California | — | — |
| 1248.7.01028 Boehringer Ingelheim Investigational Site | Palmdale | California | — | — |
| 1248.7.01044 Boehringer Ingelheim Investigational Site | Stockton | California | — | — |
| 1248.7.01015 Boehringer Ingelheim Investigational Site | Centennial | Colorado | — | — |
| 1248.7.01035 Boehringer Ingelheim Investigational Site | Aventura | Florida | — | — |
| 1248.7.01022 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1248.7.01051 Boehringer Ingelheim Investigational Site | Columbus | Georgia | — | — |
| 1248.7.01052 Boehringer Ingelheim Investigational Site | Savannah | Georgia | — | — |
| 1248.7.01011 Boehringer Ingelheim Investigational Site | Eagle | Idaho | — | — |
| 1248.7.01055 Boehringer Ingelheim Investigational Site | Oak Lawn | Illinois | — | — |
| 1248.7.01019 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | — | — |
| 1248.7.01039 Boehringer Ingelheim Investigational Site | North Dartmouth | Massachusetts | — | — |
| 1248.7.01037 Boehringer Ingelheim Investigational Site | Ypsilanti | Michigan | — | — |
| 1248.7.01056 Boehringer Ingelheim Investigational Site | Rolla | Missouri | — | — |
| 1248.7.01036 Boehringer Ingelheim Investigational Site | Warrensburg | Missouri | — | — |
| 1248.7.01020 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | — | — |
| 1248.7.01049 Boehringer Ingelheim Investigational Site | Berlin | New Jersey | — | — |
| 1248.7.01026 Boehringer Ingelheim Investigational Site | Ocean City | New Jersey | — | — |
| 1248.7.01054 Boehringer Ingelheim Investigational Site | Trenton | New Jersey | — | — |
| 1248.7.01031 Boehringer Ingelheim Investigational Site | High Point | North Carolina | — | — |
| 1248.7.01045 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1248.7.01021 Boehringer Ingelheim Investigational Site | Portland | Oregon | — | — |
| 1248.7.01013 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | — | — |
| 1248.7.01040 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | — | — |
| 1248.7.01012 Boehringer Ingelheim Investigational Site | Upland | Pennsylvania | — | — |
| 1248.7.01048 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | — | — |
| 1248.7.01050 Boehringer Ingelheim Investigational Site | Austin | Texas | — | — |
| 1248.7.01002 Boehringer Ingelheim Investigational Site | Live Oak | Texas | — | — |
| 1248.7.01032 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1248.7.01046 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1248.7.01001 Boehringer Ingelheim Investigational Site | Waco | Texas | — | — |
| 1248.7.01025 Boehringer Ingelheim Investigational Site | Murray | Utah | — | — |
| 1248.7.01053 Boehringer Ingelheim Investigational Site | Alexandria | Virginia | — | — |
| 1248.7.01030 Boehringer Ingelheim Investigational Site | Tacoma | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01396278, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 7, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01396278 live on ClinicalTrials.gov.