Clinical trial NCT01092143: BI 671800 ED in Steroid-naive Asthmatic Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-03-24
Enrollment: 389
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment
timeFrame: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.
Secondary outcomes:
measure: Asthma Control Questionnaire (ACQ) Mean Score Change From Baseline After Six Weeks of Treatment
timeFrame: Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: 1268.17.01043 Boehringer Ingelheim Investigational Site
state: Arizona
city: Cypress
country: United States
facility: 1268.17.01009 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1268.17.01006 Boehringer Ingelheim Investigational Site
state: California
city: Palmdale
country: United States
facility: 1268.17.01040 Boehringer Ingelheim Investigational Site
state: California
city: San Jose
country: United States
facility: 1268.17.01024 Boehringer Ingelheim Investigational Site
state: California
city: Stockton
country: United States
facility: 1268.17.01003 Boehringer Ingelheim Investigational Site
state: California
city: Colorado Springs
country: United States
facility: 1268.17.01015 Boehringer Ingelheim Investigational Site
state: Colorado
city: Denver
country: United States
facility: 1268.17.01001 Boehringer Ingelheim Investigational Site
state: Colorado
city: Lakewood
country: United States
facility: 1268.17.01016 Boehringer Ingelheim Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: 1268.17.01033 Boehringer Ingelheim Investigational Site
state: Colorado
city: DeLand
country: United States
facility: 1268.17.01045 Boehringer Ingelheim Investigational Site
state: Florida
city: Normal
country: United States
facility: 1268.17.01036 Boehringer Ingelheim Investigational Site
state: Illinois
city: South Bend
country: United States
facility: 1268.17.01025 Boehringer Ingelheim Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: 1268.17.01005 Boehringer Ingelheim Investigational Site
state: Iowa
city: Baltimore
country: United States
facility: 1268.17.01034 Boehringer Ingelheim Investigational Site
state: Maryland
city: North Dartmouth
country: United States
facility: 1268.17.01014 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: North Dartmouth
country: United States
facility: 1268.17.01030 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Novi
country: United States
facility: 1268.17.01027 Boehringer Ingelheim Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: 1268.17.01032 Boehringer Ingelheim Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: 1268.17.01010 Boehringer Ingelheim Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: 1268.17.01037 Boehringer Ingelheim Investigational Site
state: Missouri
city: Bozeman
country: United States
facility: 1268.17.01022 Boehringer Ingelheim Investigational Site
state: Montana
city: Bellevue
country: United States
facility: 1268.17.01008 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Raleigh
country: United States
facility: 1268.17.01011 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 1268.17.01004 Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: 1268.17.01038 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: 1268.17.01042 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: 1268.17.01007 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Easley
country: United States
facility: 1268.17.01031 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Fort Mill
country: United States
facility: 1268.17.01039 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 1268.17.01026 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 1268.17.01029 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: 1268.17.01049 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: 1268.17.01019 Boehringer Ingelheim Investigational Site
state: Texas
city: El Paso
country: United States
facility: 1268.17.01012 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1268.17.01023 Boehringer Ingelheim Investigational Site
state: Texas
city: Killeen
country: United States
facility: 1268.17.01048 Boehringer Ingelheim Investigational Site
state: Texas
city: New Braunfels
country: United States
facility: 1268.17.01028 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1268.17.01035 Boehringer Ingelheim Investigational Site
state: Texas
city: Tacoma
country: United States
facility: 1268.17.01047 Boehringer Ingelheim Investigational Site
state: Washington
city: Adelaide
country: Australia
facility: 1268.17.61001 Boehringer Ingelheim Investigational Site
state: South Australia
city: Hawkesbury
country: Canada
facility: 1268.17.02012 Boehringer Ingelheim Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: 1268.17.02010 Boehringer Ingelheim Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: 1268.17.02014 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: 1268.17.02015 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1268.17.02003 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1268.17.02013 Boehringer Ingelheim Investigational Site
state: Ontario
city: Quebec
country: Canada
facility: 1268.17.02001 Boehringer Ingelheim Investigational Site
city: Quebec
country: Canada
facility: 1268.17.02004 Boehringer Ingelheim Investigational Site
city: Bogotá
country: Colombia
facility: 1268.17.57003 Boehringer Ingelheim Investigational Site
city: Bogotá
country: Colombia
facility: 1268.17.57004 Boehringer Ingelheim Investigational Site
city: Medellín
country: Colombia
facility: 1268.17.57002 Boehringer Ingelheim Investigational Site
city: Cheongju
country: Korea, Republic of
facility: 1268.17.82007 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1268.17.82001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1268.17.82002 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1268.17.82004 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1268.17.82005 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1268.17.82006 Boehringer Ingelheim Investigational Site
city: Suwon
country: Korea, Republic of
facility: 1268.17.82003 Boehringer Ingelheim Investigational Site
city: Wonju
country: Korea, Republic of
facility: 1268.17.82008 Boehringer Ingelheim Investigational Site
city: Cuernavaca
country: Mexico
facility: 1268.17.52002 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1268.17.52001 Boehringer Ingelheim Investigational Site
city: Toriello Guerra
country: Mexico
facility: 1268.17.52004 Boehringer Ingelheim Investigational Site
city: Zona Río
country: Mexico
facility: 1268.17.52003 Boehringer Ingelheim Investigational Site
city: Christchurch
country: New Zealand
facility: 1268.17.64001 Boehringer Ingelheim Investigational Site
city: Greenlane East Auckland
country: New Zealand
facility: 1268.17.64003 Boehringer Ingelheim Investigational Site
city: Newtown Wellington NZ
country: New Zealand
facility: 1268.17.64002 Boehringer Ingelheim Investigational Site
city: Jesús María
country: Peru
facility: 1268.17.51003 Boehringer Ingelheim Investigational Site
city: Lima
country: Peru
facility: 1268.17.51002 Boehringer Ingelheim Investigational Site
city: San Borja
country: Peru
facility: 1268.17.51006 Boehringer Ingelheim Investigational Site
city: San Isidro.
country: Peru
facility: 1268.17.51004 Boehringer Ingelheim Investigational Site
city: Santiago de Surco
country: Peru
facility: 1268.17.51005 Boehringer Ingelheim Investigational Site
city: Urb. Ingeniería
country: Peru
facility: 1268.17.51001 Boehringer Ingelheim Investigational Site
city: Caloocan City
country: Philippines
facility: 1268.17.63007 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1268.17.63002 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1268.17.63001 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1268.17.63003 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1268.17.63004 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1268.17.63005 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1268.17.63006 Boehringer Ingelheim Investigational Site
city: Chiayi City
country: Taiwan
facility: 1268.17.86210 Boehringer Ingelheim Investigational Site
city: Kaohsiung City
country: Taiwan
facility: 1268.17.86211 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 1268.17.86207 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 1268.17.86208 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 1268.17.86209 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1268.17.86201 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1268.17.86202 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1268.17.86203 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1268.17.86204 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1268.17.86205 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1268.17.86206 Boehringer Ingelheim Investigational Site
city: Taoyuan County
country: Taiwan
facility: 1268.17.86200 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: