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
Public ClinicalTrials.gov record NCT01397162. 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, Placebo-controlled, Parallel-group Study to Assess and Compare Efficacy and Safety of an 8-week Treatment With BI 54903 at Doses of 22.7, 45.5 and 90.9 Doses b.i.d. Administered Via Respimat® Inhaler and Fluticasone Propionate HFA MDI 88 mcg b.i.d. in Patients With Asthma Inadequately Controlled on SABA 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 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
Study identification
- NCT ID
- NCT01397162
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 29 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 20, 2011
- Primary completion
- Dec 22, 2011
- Completion
- Dec 22, 2011
- Last update posted
- Jun 22, 2022
2011
United States locations
- U.S. sites
- 41
- U.S. states
- 22
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1248.5.01047 Boehringer Ingelheim Investigational Site | Fountain Valley | California | — | — |
| 1248.5.01041 Boehringer Ingelheim Investigational Site | Huntington Beach | California | — | — |
| 1248.5.01038 Boehringer Ingelheim Investigational Site | Long Beach | California | — | — |
| 1248.5.01004 Boehringer Ingelheim Investigational Site | Mission Viejo | California | — | — |
| 1248.5.01028 Boehringer Ingelheim Investigational Site | Palmdale | California | — | — |
| 1248.5.01014 Boehringer Ingelheim Investigational Site | Rancho Mirage | California | — | — |
| 1248.5.01044 Boehringer Ingelheim Investigational Site | Stockton | California | — | — |
| 1248.5.01015 Boehringer Ingelheim Investigational Site | Centennial | Colorado | — | — |
| 1248.5.01022 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1248.5.01042 Boehringer Ingelheim Investigational Site | Sarasota | Florida | — | — |
| 1248.5.01051 Boehringer Ingelheim Investigational Site | Columbus | Georgia | — | — |
| 1248.5.01052 Boehringer Ingelheim Investigational Site | Savannah | Georgia | — | — |
| 1248.5.01011 Boehringer Ingelheim Investigational Site | Eagle | Idaho | — | — |
| 1248.5.01055 Boehringer Ingelheim Investigational Site | Oak Lawn | Illinois | — | — |
| 1248.5.01019 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | — | — |
| 1248.5.01039 Boehringer Ingelheim Investigational Site | North Dartmouth | Massachusetts | — | — |
| 1248.5.01037 Boehringer Ingelheim Investigational Site | Ypsilanti | Michigan | — | — |
| 1248.5.01056 Boehringer Ingelheim Investigational Site | Rolla | Missouri | — | — |
| 1248.5.01036 Boehringer Ingelheim Investigational Site | Warrensburg | Missouri | — | — |
| 1248.5.01020 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | — | — |
| 1248.5.01049 Boehringer Ingelheim Investigational Site | Berlin | New Jersey | — | — |
| 1248.5.01054 Boehringer Ingelheim Investigational Site | Trenton | New Jersey | — | — |
| 1248.5.01010 Boehringer Ingelheim Investigational Site | Verona | New Jersey | — | — |
| 1248.5.01006 Boehringer Ingelheim Investigational Site | Rochester | New York | — | — |
| 1248.5.01031 Boehringer Ingelheim Investigational Site | High Point | North Carolina | — | — |
| 1248.5.01045 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1248.5.01005 Boehringer Ingelheim Investigational Site | Gresham | Oregon | — | — |
| 1248.5.01021 Boehringer Ingelheim Investigational Site | Portland | Oregon | — | — |
| 1248.5.01013 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | — | — |
| 1248.5.01040 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | — | — |
| 1248.5.01012 Boehringer Ingelheim Investigational Site | Upland | Pennsylvania | — | — |
| 1248.5.01048 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | — | — |
| 1248.5.01050 Boehringer Ingelheim Investigational Site | Austin | Texas | — | — |
| 1248.5.01002 Boehringer Ingelheim Investigational Site | Live Oak | Texas | — | — |
| 1248.5.01032 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1248.5.01046 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1248.5.01001 Boehringer Ingelheim Investigational Site | Waco | Texas | — | — |
| 1248.5.01007 Boehringer Ingelheim Investigational Site | Waco | Texas | — | — |
| 1248.5.01025 Boehringer Ingelheim Investigational Site | Murray | Utah | — | — |
| 1248.5.01053 Boehringer Ingelheim Investigational Site | Alexandria | Virginia | — | — |
| 1248.5.01030 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 NCT01397162, 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 Jun 22, 2022 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01397162 live on ClinicalTrials.gov.