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
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: BI 671800
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

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 response after 4 weeks of treatment. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Asthma Control Questionnaire (ACQ) total score change from baseline after four weeks of treatment. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: March 2010
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 671800 AM and PM
Patients receiving two capsules twice daily
Drug: BI 671800
Double blind randomised cross-over study to assess efficacy, safety and tolerability
Experimental: BI 671800 AM
Patients receiving four capsules in the morning
Drug: BI 671800
Double blind randomised cross-over study to assess efficacy, safety and tolerability
Experimental: BI 671800 PM
Patients receiving four capsules in the evening
Drug: BI 671800
Double blind randomised cross-over study to assess efficacy, safety and tolerability
Placebo Comparator: Placebo
Patients receiving four capsules twice a day
Drug: Placebo
Patients receive placebo capsules

  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 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.
  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: NCT01090024

Locations
United States, California
1268.53.01013 Boehringer Ingelheim Investigational Site
Huntington Beach, California, United States
1268.53.01014 Boehringer Ingelheim Investigational Site
Mission Viejo, California, United States
1268.53.01002 Boehringer Ingelheim Investigational Site
Stockton, California, United States
United States, Colorado
1268.53.01009 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado, United States
1268.53.01011 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
United States, Massachusetts
1268.53.01001 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts, United States
United States, Minnesota
1268.53.01005 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
United States, Missouri
1268.53.01006 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
United States, North Carolina
1268.53.01007 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, United States
United States, Oregon
1268.53.01010 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, South Carolina
1268.53.01003 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
United States, Texas
1268.53.01008 Boehringer Ingelheim Investigational Site
El Paso, Texas, United States
1268.53.01012 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
United States, Virginia
1268.53.01015 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
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: NCT01090024     History of Changes
Other Study ID Numbers: 1268.53
Study First Received: March 18, 2010
Last Updated: April 30, 2014
Health Authority: 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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 19, 2014