BI 671800 ED in Steroid-naive Asthmatic Patients
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01092143
First received: March 19, 2010
Last updated: August 23, 2011
Last verified: August 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: BI671800 Drug: BI 671800 Drug: Fluticasone placebo Drug: Fluticasone Drug: BI 671800 Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double Blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of 6-week Treatment With Oral Doses of 50 mg b.i.d., 200 mg b.i.d., and 400 mg b.i.d. BI 671800 ED in Steroid-naïve Patients With Persistent Asthma |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Forced expiratory volume in one second (FEV1) % predicted trough change from baseline after six weeks of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Asthma Control Questionnaire (ACQ) total score change from baseline after six weeks of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 389 |
| Study Start Date: | March 2010 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BI671800 (low dose)
Patients receive BI671800 (low dose) capsules twice daily
|
Drug: BI 671800
double blind randomized parallel
Drug: Fluticasone placebo
double blind randomized parallel
|
|
Active Comparator: Fluticasone
Patients inhale from Fluticasone MDI twice daily
|
Drug: Fluticasone
double blind randomized parallel
Drug: BI 671800 Placebo
double blind randomized parallel
|
|
Placebo Comparator: placebo
Patients receive placebo capsules twice daily
|
Drug: Fluticasone placebo
double blind randomized parallel
Drug: BI 671800 Placebo
double blind randomized parallel
|
|
Experimental: BI671800 (medium dose)
Patients receive BI671800 (medium dose) capsules twice daily
|
Drug: BI671800
double blind randomized parallel group study
Drug: Fluticasone placebo
double blind randomized parallel
|
|
Experimental: BI671800 (high dose)
Patients receive BI671800 (high dose) capsules twice daily
|
Drug: BI671800
double blind randomized parallel group study
Drug: Fluticasone placebo
double blind randomized parallel
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Signed informed consent consistent with ICH-GCP
- Three month history of reversible (12% with 200 mL) asthma (according to GINA) with following spirometry at randomization: FEV1 60%-85%.
- No ICS previous 3 months prior to screening.
- Diagnosis of asthma prior to 40 years.
- ACQ at least 1.5 at randomization.
- Male or female, 18 to 65 years.
- Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen.
- Able to perform PFT
Exclusion criteria:
- Significant diseases other than asthma or allergic rhinitis.
- Hepatic transaminases or total bilirubin greater than 1.5 ULN.
- Hospitalizations for asthma or asthma related intubation within 3 months.
- Uncontrolled asthma.
- Respiratory tract infection or exacerbation within 4 weeks.
- FEV1 less than 40%, more than 12 puffs of SABA on more than two consecutive days or asthma exacerbation during the run-in period.
- Participation in another interventional study.
- Pregnant or nursing women.
- Women of child bearing potential nor using appropriate methods of birth control as defined by protocol
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092143
Show 92 Study Locations
Show 92 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01092143 History of Changes |
| Other Study ID Numbers: | 1268.17 |
| Study First Received: | March 19, 2010 |
| Last Updated: | August 23, 2011 |
| Health Authority: | Australia: Dept of Health and Ageing Therapeutic Goods Admin Canada: Health Canada Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos Korea: Food and Drug Administration Mexico: Federal Commission for Sanitary Risks Protection New Zealand: Multi-Regional Ethics Committee Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Philippines: Bureau of Food and Drugs Taiwan: Department of Health United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013