Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01090024
First received: March 18, 2010
Last updated: April 30, 2014
Last verified: April 2014

March 18, 2010
April 30, 2014
March 2010
February 2011   (final data collection date for primary outcome measure)
Forced expiratory volume in one second (FEV1) % predicted trough response after 4 weeks of treatment. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01090024 on ClinicalTrials.gov Archive Site
Asthma Control Questionnaire (ACQ) total score change from baseline after four weeks of treatment. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids
A Randomised, Double-blind, Placebo-controlled, Efficacy and Safety Cross-over Study of 4 Weeks of Oral BI 671800 ED 200 mg Twice Daily or 400 mg Once Daily Administered in the Morning (AM) or Evening (PM), in Symptomatic Asthma Patients on Inhaled Fluticasone Propionate MDI

To investigate the effectiveness and safety of BI 671800 given in the morning (AM), evening (PM) or twice daily (b.i.d.) compared too placebo as add on therapy to inhaled corticosteroid in symptomatic asthma patients.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
  • Drug: BI 671800
    Double blind randomised cross-over study to assess efficacy, safety and tolerability
  • Drug: Placebo
    Patients receive placebo capsules
  • Experimental: BI 671800 AM and PM
    Patients receiving two capsules twice daily
    Intervention: Drug: BI 671800
  • Experimental: BI 671800 AM
    Patients receiving four capsules in the morning
    Intervention: Drug: BI 671800
  • Experimental: BI 671800 PM
    Patients receiving four capsules in the evening
    Intervention: Drug: BI 671800
  • Placebo Comparator: Placebo
    Patients receiving four capsules twice a day
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
Not Provided
February 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Signed informed consent consistent with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) (ICH-GCP)
  2. Three month history of reversible (12% with 200 mL) asthma according to [Global Initiative for Asthma (GINA)] with following spirometry at randomization:forced expiratory volume in 1 second (FEV1) 60%-85%.
  3. Stable inhaled corticosteroid (ICS) dose 3 months prior to screening.
  4. Diagnosis of asthma prior to 40 years.
  5. Asthma Control Questionnaire (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 pulmonary function test (PFT).

Exclusion criteria:

  1. Significant diseases other than asthma or allergic rhinitis.
  2. Hepatic transaminases or total bilirubin greater than 1.5 upper limit of normal (ULN).
  3. Hospitalizations for asthma or asthma related intubation within 3 months.
  4. Uncontrolled asthma on ICS + another controller.
  5. Respiratory tract infection or exacerbation within 4 weeks.
  6. FEV1 less than 40%, more than 12 puffs of short acting beta agonists (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
 
NCT01090024
1268.53
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