Clinical trial NCT01090024: Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-03-19
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

1. Signed informed consent consistent with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) (ICH-GCP)
2. 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%.
3. Stable inhaled corticosteroid (ICS) dose 3 months prior to screening.
4. Diagnosis of asthma prior to 40 years.
5. Asthma Control Questionnaire (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 pulmonary function test (PFT).

Exclusion criteria:

1. Significant diseases other than asthma or allergic rhinitis.
2. Hepatic transaminases or total bilirubin greater than 1.5 upper limit of normal (ULN).
3. Hospitalizations for asthma or asthma related intubation within 3 months.
4. Uncontrolled asthma on ICS + another controller.
5. Respiratory tract infection or exacerbation within 4 weeks.
6. 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.
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.

Primary outcomes:
measure: Change From Baseline of Trough Forced Expiratory Volume in One Second (FEV1) Percent Predicted After 4 Weeks of Treatment
timeFrame: At baseline and 4 weeks
Secondary outcomes:
measure: Change From Baseline in Asthma Control Questionnaire (ACQ) Mean Score After Four Weeks of Treatment
timeFrame: At baseline and 4 weeks
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: 1268.53.01013 Boehringer Ingelheim Investigational Site
state: California
city: Mission Viejo
country: United States
facility: 1268.53.01014 Boehringer Ingelheim Investigational Site
state: California
city: Stockton
country: United States
facility: 1268.53.01002 Boehringer Ingelheim Investigational Site
state: California
city: Colorado Springs
country: United States
facility: 1268.53.01009 Boehringer Ingelheim Investigational Site
state: Colorado
city: Denver
country: United States
facility: 1268.53.01011 Boehringer Ingelheim Investigational Site
state: Colorado
city: North Dartmouth
country: United States
facility: 1268.53.01001 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: 1268.53.01005 Boehringer Ingelheim Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: 1268.53.01006 Boehringer Ingelheim Investigational Site
state: Missouri
city: Raleigh
country: United States
facility: 1268.53.01007 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Portland
country: United States
facility: 1268.53.01010 Boehringer Ingelheim Investigational Site
state: Oregon
city: Charleston
country: United States
facility: 1268.53.01003 Boehringer Ingelheim Investigational Site
state: South Carolina
city: El Paso
country: United States
facility: 1268.53.01008 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1268.53.01012 Boehringer Ingelheim Investigational Site
state: Texas
city: Richmond
country: United States
facility: 1268.53.01015 Boehringer Ingelheim Investigational Site
state: Virginia
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: