BI 671800 ED in Steroid-naive Asthmatic Patients
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01092143
First received: March 19, 2010
Last updated: August 23, 2011
Last verified: August 2011
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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 Pharmaceuticals:
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:
- Signed informed consent consistent with ICH-GCP
- Three month history of reversible (12% with 200 mL) asthma (according to GINA) with following spirometry at randomization: FEV1 60%-85%.
- No ICS previous 3 months prior to screening.
- Diagnosis of asthma prior to 40 years.
- ACQ at least 1.5 at randomization.
- Male or female, 18 to 65 years.
- Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen.
- Able to perform PFT
Exclusion criteria:
- Significant diseases other than asthma or allergic rhinitis.
- Hepatic transaminases or total bilirubin greater than 1.5 ULN.
- Hospitalizations for asthma or asthma related intubation within 3 months.
- Uncontrolled asthma.
- Respiratory tract infection or exacerbation within 4 weeks.
- FEV1 less than 40%, more than 12 puffs of SABA on more than two consecutive days or asthma exacerbation during the run-in period.
- Participation in another interventional study.
- Pregnant or nursing women.
- 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
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| 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 Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
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 May 16, 2013