BI 671800 ED in Steroid-naive Asthmatic Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01092143
First received: March 19, 2010
Last updated: April 30, 2014
Last verified: April 2014
  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:

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:

  1. Signed informed consent consistent with ICH-GCP
  2. Three month history of reversible (12% with 200 mL) asthma (according to GINA) with following spirometry at randomization: FEV1 60%-85%.
  3. No ICS previous 3 months prior to screening.
  4. Diagnosis of asthma prior to 40 years.
  5. ACQ at least 1.5 at randomization.
  6. Male or female, 18 to 65 years.
  7. Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen.
  8. Able to perform PFT

Exclusion criteria:

  1. Significant diseases other than asthma or allergic rhinitis.
  2. Hepatic transaminases or total bilirubin greater than 1.5 ULN.
  3. Hospitalizations for asthma or asthma related intubation within 3 months.
  4. Uncontrolled asthma.
  5. Respiratory tract infection or exacerbation within 4 weeks.
  6. FEV1 less than 40%, more than 12 puffs of SABA on more than two consecutive days or asthma exacerbation during the run-in period.
  7. Participation in another interventional study.
  8. Pregnant or nursing women.
  9. Women of child bearing potential nor using appropriate methods of birth control as defined by protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092143

  Show 92 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  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: April 30, 2014
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 July 26, 2014