Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids
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
1 other identifier
interventional
108
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Mar 2010
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 18, 2010
CompletedFirst Posted
Study publicly available on registry
March 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2011
CompletedResults Posted
Study results publicly available
May 11, 2022
CompletedMay 11, 2022
May 1, 2022
11 months
March 18, 2010
April 7, 2022
May 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline of Trough Forced Expiratory Volume in One Second (FEV1) Percent Predicted After 4 Weeks of Treatment
Trough FEV1 percent (%) predicted was defined as the mean of the morning and the evening FEV1 % predicted daily trough value at the end of the dosing interval. For the morning (evening) measurements, when FEV1 % predicted was available at both 25 minutes and 10 minutes prior to morning (evening) test-drug inhalation, morning (evening) trough FEV1 % predicted was the mean of these two morning (evening) pre-inhalation measurements. Trough FEV1 % predicted change from baseline after 4 weeks of treatment was defined as the change from baseline in the mean of the morning and the evening trough FEV1 % predicted.
At baseline and 4 weeks
Secondary Outcomes (1)
Change From Baseline in Asthma Control Questionnaire (ACQ) Mean Score After Four Weeks of Treatment
At baseline and 4 weeks
Study Arms (4)
BI 671800 AM and PM
EXPERIMENTALPatients receiving two capsules twice daily
BI 671800 AM
EXPERIMENTALPatients receiving four capsules in the morning
BI 671800 PM
EXPERIMENTALPatients receiving four capsules in the evening
Placebo
PLACEBO COMPARATORPatients receiving four capsules twice a day
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent consistent with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) (ICH-GCP)
- 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%.
- Stable inhaled corticosteroid (ICS) dose 3 months prior to screening.
- Diagnosis of asthma prior to 40 years.
- Asthma Control Questionnaire (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 pulmonary function test (PFT).
You may not qualify if:
- Significant diseases other than asthma or allergic rhinitis.
- Hepatic transaminases or total bilirubin greater than 1.5 upper limit of normal (ULN).
- Hospitalizations for asthma or asthma related intubation within 3 months.
- Uncontrolled asthma on ICS + another controller.
- Respiratory tract infection or exacerbation within 4 weeks.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
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
1268.53.01009 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado, United States
1268.53.01011 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
1268.53.01001 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts, United States
1268.53.01005 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
1268.53.01006 Boehringer Ingelheim Investigational Site
St Louis, Missouri, United States
1268.53.01007 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, United States
1268.53.01010 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
1268.53.01003 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
1268.53.01008 Boehringer Ingelheim Investigational Site
El Paso, Texas, United States
1268.53.01012 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1268.53.01015 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2010
First Posted
March 19, 2010
Study Start
March 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 18, 2011
Last Updated
May 11, 2022
Results First Posted
May 11, 2022
Record last verified: 2022-05