BI 671800 ED in Steroid-naive Asthmatic Patients
Completed · Phase 2 · Has a placebo group
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT01092143
- Run by
- Boehringer Ingelheim
- People needed
- 389
- Starts
- 2010-03-18
- Expected to finish
- 2011-03-26
- Last updated by the study team
- 2022-05-31
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- 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
- 1268.17.01045 Boehringer Ingelheim Investigational Site — DeLand, Florida, United States
- 1268.17.01036 Boehringer Ingelheim Investigational Site — Normal, Illinois, United States
- 1268.17.01025 Boehringer Ingelheim Investigational Site — South Bend, Indiana, United States
- 1268.17.01005 Boehringer Ingelheim Investigational Site — Iowa City, Iowa, United States
- 1268.17.01034 Boehringer Ingelheim Investigational Site — Baltimore, Maryland, United States
- 1268.17.01014 Boehringer Ingelheim Investigational Site — North Dartmouth, Massachusetts, United States
- 1268.17.01030 Boehringer Ingelheim Investigational Site — North Dartmouth, Massachusetts, United States
- 1268.17.01027 Boehringer Ingelheim Investigational Site — Novi, Michigan, United States
- 1268.17.01032 Boehringer Ingelheim Investigational Site — Minneapolis, Minnesota, United States
- 1268.17.01010 Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
- 1268.17.01037 Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
- 1268.17.01022 Boehringer Ingelheim Investigational Site — Bozeman, Montana, United States
- 1268.17.01008 Boehringer Ingelheim Investigational Site — Bellevue, Nebraska, United States
- 1268.17.01011 Boehringer Ingelheim Investigational Site — Raleigh, North Carolina, United States
- 1268.17.01004 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
- 1268.17.01043 Boehringer Ingelheim Investigational Site — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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