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

March 19, 2010
April 30, 2014
March 2010
April 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01092143 on ClinicalTrials.gov Archive Site
Asthma Control Questionnaire (ACQ) total score change from baseline after six weeks of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
BI 671800 ED in Steroid-naive Asthmatic Patients
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
  • Drug: BI671800
    double blind randomized parallel group study
  • Drug: BI 671800
    double blind randomized parallel
  • Drug: Fluticasone placebo
    double blind randomized parallel
  • Drug: Fluticasone
    double blind randomized parallel
  • Drug: BI 671800 Placebo
    double blind randomized parallel
  • Experimental: BI671800 (low dose)
    Patients receive BI671800 (low dose) capsules twice daily
    Interventions:
    • Drug: BI 671800
    • Drug: Fluticasone placebo
  • Active Comparator: Fluticasone
    Patients inhale from Fluticasone MDI twice daily
    Interventions:
    • Drug: Fluticasone
    • Drug: BI 671800 Placebo
  • Placebo Comparator: placebo
    Patients receive placebo capsules twice daily
    Interventions:
    • Drug: Fluticasone placebo
    • Drug: BI 671800 Placebo
  • Experimental: BI671800 (medium dose)
    Patients receive BI671800 (medium dose) capsules twice daily
    Interventions:
    • Drug: BI671800
    • Drug: Fluticasone placebo
  • Experimental: BI671800 (high dose)
    Patients receive BI671800 (high dose) capsules twice daily
    Interventions:
    • Drug: BI671800
    • Drug: Fluticasone placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
389
Not Provided
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Colombia,   Korea, Republic of,   Mexico,   New Zealand,   Peru,   Philippines,   Taiwan
 
NCT01092143
1268.17
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP