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: August 23, 2011
Last verified: August 2011
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092143

  Hide Study Locations
Locations
United States, Arizona
1268.17.01043 Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
United States, California
1268.17.01009 Boehringer Ingelheim Investigational Site
Cypress, California, United States
1268.17.01006 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1268.17.01040 Boehringer Ingelheim Investigational Site
Palmdale, California, United States
1268.17.01024 Boehringer Ingelheim Investigational Site
San Jose, California, United States
1268.17.01003 Boehringer Ingelheim Investigational Site
Stockton, California, United States
United States, Colorado
1268.17.01015 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado, United States
1268.17.01001 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
1268.17.01016 Boehringer Ingelheim Investigational Site
Lakewood, Colorado, United States
1268.17.01033 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
United States, Florida
1268.17.01045 Boehringer Ingelheim Investigational Site
Deland, Florida, United States
United States, Illinois
1268.17.01036 Boehringer Ingelheim Investigational Site
Normal, Illinois, United States
United States, Indiana
1268.17.01025 Boehringer Ingelheim Investigational Site
South Bend, Indiana, United States
United States, Iowa
1268.17.01005 Boehringer Ingelheim Investigational Site
Iowa City, Iowa, United States
United States, Maryland
1268.17.01034 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
United States, Massachusetts
1268.17.01030 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts, United States
1268.17.01014 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts, United States
United States, Michigan
1268.17.01027 Boehringer Ingelheim Investigational Site
Novi, Michigan, United States
United States, Minnesota
1268.17.01032 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
United States, Missouri
1268.17.01037 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
1268.17.01010 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
United States, Montana
1268.17.01022 Boehringer Ingelheim Investigational Site
Bozeman, Montana, United States
United States, Nebraska
1268.17.01008 Boehringer Ingelheim Investigational Site
Bellevue, Nebraska, United States
United States, North Carolina
1268.17.01011 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, United States
United States, Ohio
1268.17.01004 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
United States, Oklahoma
1268.17.01038 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
1268.17.01042 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, South Carolina
1268.17.01007 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
1268.17.01031 Boehringer Ingelheim Investigational Site
Easley, South Carolina, United States
1268.17.01039 Boehringer Ingelheim Investigational Site
Fort Mill, South Carolina, United States
1268.17.01029 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1268.17.01026 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1268.17.01049 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
United States, Texas
1268.17.01019 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1268.17.01012 Boehringer Ingelheim Investigational Site
El Paso, Texas, United States
1268.17.01023 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1268.17.01048 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States
1268.17.01028 Boehringer Ingelheim Investigational Site
New Braunfels, Texas, United States
1268.17.01035 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
United States, Washington
1268.17.01047 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
Australia, South Australia
1268.17.61001 Boehringer Ingelheim Investigational Site
Adelaide, South Australia, Australia
Canada, Ontario
1268.17.02012 Boehringer Ingelheim Investigational Site
Hawkesbury, Ontario, Canada
1268.17.02010 Boehringer Ingelheim Investigational Site
Mississauga, Ontario, Canada
1268.17.02014 Boehringer Ingelheim Investigational Site
Newmarket, Ontario, Canada
1268.17.02015 Boehringer Ingelheim Investigational Site
Sudbury, Ontario, Canada
1268.17.02013 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1268.17.02003 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada
1268.17.02004 Boehringer Ingelheim Investigational Site
Quebec, Canada
1268.17.02001 Boehringer Ingelheim Investigational Site
Quebec, Canada
Colombia
1268.17.57004 Boehringer Ingelheim Investigational Site
Bogotá, Colombia
1268.17.57003 Boehringer Ingelheim Investigational Site
Bogotá, Colombia
1268.17.57002 Boehringer Ingelheim Investigational Site
Medellín, Colombia
Korea, Republic of
1268.17.82007 Boehringer Ingelheim Investigational Site
Cheongju, Korea, Republic of
1268.17.82002 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1268.17.82006 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1268.17.82005 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1268.17.82004 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1268.17.82001 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1268.17.82003 Boehringer Ingelheim Investigational Site
Suwon, Korea, Republic of
1268.17.82008 Boehringer Ingelheim Investigational Site
Wonju, Korea, Republic of
Mexico
1268.17.52002 Boehringer Ingelheim Investigational Site
Cuernavaca, Mexico
1268.17.52001 Boehringer Ingelheim Investigational Site
Monterrey, Mexico
1268.17.52004 Boehringer Ingelheim Investigational Site
Toriello Guerra, Mexico
1268.17.52003 Boehringer Ingelheim Investigational Site
Zona Río, Mexico
New Zealand
1268.17.64001 Boehringer Ingelheim Investigational Site
Christchurch, New Zealand
1268.17.64003 Boehringer Ingelheim Investigational Site
Greenlane East Auckland, New Zealand
1268.17.64002 Boehringer Ingelheim Investigational Site
Newtown Wellington NZ, New Zealand
Peru
1268.17.51003 Boehringer Ingelheim Investigational Site
Jesús María, Peru
1268.17.51002 Boehringer Ingelheim Investigational Site
Lima, Peru
1268.17.51006 Boehringer Ingelheim Investigational Site
San Borja, Peru
1268.17.51004 Boehringer Ingelheim Investigational Site
San Isidro., Peru
1268.17.51005 Boehringer Ingelheim Investigational Site
Santiago de Surco, Peru
1268.17.51001 Boehringer Ingelheim Investigational Site
Urb. Ingeniería, Peru
Philippines
1268.17.63007 Boehringer Ingelheim Investigational Site
Caloocan City, Philippines
1268.17.63002 Boehringer Ingelheim Investigational Site
Manila, Philippines
1268.17.63001 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
1268.17.63005 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
1268.17.63004 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
1268.17.63003 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
1268.17.63006 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
Taiwan
1268.17.86210 Boehringer Ingelheim Investigational Site
Chiayi City, Taiwan
1268.17.86211 Boehringer Ingelheim Investigational Site
Kaohsiung City, Taiwan
1268.17.86209 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
1268.17.86208 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
1268.17.86207 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
1268.17.86206 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1268.17.86205 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1268.17.86204 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1268.17.86203 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1268.17.86202 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1268.17.86201 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1268.17.86200 Boehringer Ingelheim Investigational Site
Taoyuan County, Taiwan
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: 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 April 23, 2014