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
- NCT01092143
- PHASE2
- INTERVENTIONAL
Last updated: 2022-05-31
Purpose of Trial
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.
This study is for people with
Asthma
Interventions being studied
BI 671800
Fluticasone propionate placebo
Fluticasone propionate
BI 671800 Placebo
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
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
40 Locations
Tucson
1268.17.01043 Boehringer Ingelheim Investigational Site
Arizona, United States
Cypress
1268.17.01009 Boehringer Ingelheim Investigational Site
California, United States
Los Angeles
1268.17.01006 Boehringer Ingelheim Investigational Site
California, United States
Palmdale
1268.17.01040 Boehringer Ingelheim Investigational Site
California, United States
San Jose
1268.17.01024 Boehringer Ingelheim Investigational Site
California, United States
Stockton
1268.17.01003 Boehringer Ingelheim Investigational Site
California, United States
Colorado Springs
1268.17.01015 Boehringer Ingelheim Investigational Site
Colorado, United States
Denver
1268.17.01001 Boehringer Ingelheim Investigational Site
Colorado, United States
Lakewood
1268.17.01016 Boehringer Ingelheim Investigational Site
Colorado, United States
Wheat Ridge
1268.17.01033 Boehringer Ingelheim Investigational Site
Colorado, United States
DeLand
1268.17.01045 Boehringer Ingelheim Investigational Site
Florida, United States
Normal
1268.17.01036 Boehringer Ingelheim Investigational Site
Illinois, United States
South Bend
1268.17.01025 Boehringer Ingelheim Investigational Site
Indiana, United States
Iowa City
1268.17.01005 Boehringer Ingelheim Investigational Site
Iowa, United States
Baltimore
1268.17.01034 Boehringer Ingelheim Investigational Site
Maryland, United States
North Dartmouth
1268.17.01014 Boehringer Ingelheim Investigational Site
Massachusetts, United States
North Dartmouth
1268.17.01030 Boehringer Ingelheim Investigational Site
Massachusetts, United States
Novi
1268.17.01027 Boehringer Ingelheim Investigational Site
Michigan, United States
Minneapolis
1268.17.01032 Boehringer Ingelheim Investigational Site
Minnesota, United States
Saint Louis
1268.17.01010 Boehringer Ingelheim Investigational Site
Missouri, United States
Saint Louis
1268.17.01037 Boehringer Ingelheim Investigational Site
Missouri, United States
Bozeman
1268.17.01022 Boehringer Ingelheim Investigational Site
Montana, United States
Bellevue
1268.17.01008 Boehringer Ingelheim Investigational Site
Nebraska, United States
Raleigh
1268.17.01011 Boehringer Ingelheim Investigational Site
North Carolina, United States
Cincinnati
1268.17.01004 Boehringer Ingelheim Investigational Site
Ohio, United States
Oklahoma City
1268.17.01038 Boehringer Ingelheim Investigational Site
Oklahoma, United States
Philadelphia
1268.17.01042 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Charleston
1268.17.01007 Boehringer Ingelheim Investigational Site
South Carolina, United States
Easley
1268.17.01031 Boehringer Ingelheim Investigational Site
South Carolina, United States
Fort Mill
1268.17.01039 Boehringer Ingelheim Investigational Site
South Carolina, United States
Greenville
1268.17.01026 Boehringer Ingelheim Investigational Site
South Carolina, United States
Greenville
1268.17.01029 Boehringer Ingelheim Investigational Site
South Carolina, United States
Spartanburg
1268.17.01049 Boehringer Ingelheim Investigational Site
South Carolina, United States
Dallas
1268.17.01019 Boehringer Ingelheim Investigational Site
Texas, United States
El Paso
1268.17.01012 Boehringer Ingelheim Investigational Site
Texas, United States
Houston
1268.17.01023 Boehringer Ingelheim Investigational Site
Texas, United States
Killeen
1268.17.01048 Boehringer Ingelheim Investigational Site
Texas, United States
New Braunfels
1268.17.01028 Boehringer Ingelheim Investigational Site
Texas, United States
San Antonio
1268.17.01035 Boehringer Ingelheim Investigational Site
Texas, United States
Tacoma
1268.17.01047 Boehringer Ingelheim Investigational Site
Washington, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov