BI 671800 ED in Steroid-naive Asthmatic Patients

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: BI 671800; Drug: Fluticasone propionate; Drug: Fluticasone propionate placebo; Drug: BI 671800 Placebo

• Registration Number: NCT01092143
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-18
• Study First Submitted: 2010-03-19
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Primary Completion: 2011-03-26
• Study Completion: 2011-03-26
• Disposition First Submitted: 2014-04-30
• Disposition First Submitted QC: 2014-04-30
• Disposition First Posted: 2014-05-16
• Results First Submitted: 2022-04-07
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-27
• Last Update Submitted: 2022-05-27
• Results First Posted: 2022-05-31
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 671800 (low dose)	BI 671800	Patients receive BI 671800 (low dose) capsules twice daily
BI 671800 (low dose)	Fluticasone propionate placebo	Patients receive BI 671800 (low dose) capsules twice daily
Fluticasone propionate	BI 671800 Placebo	Patients inhale from Fluticasone propionate metered dose inhaler (MDI) twice daily
Placebo	BI 671800 Placebo	Patients receive placebo capsules twice daily
BI 671800 (medium dose)	BI 671800	Patients receive BI 671800 (medium dose) capsules twice daily
BI 671800 (medium dose)	Fluticasone propionate placebo	Patients receive BI 671800 (medium dose) capsules twice daily
BI 671800 (high dose)	BI 671800	Patients receive BI 671800 (high dose) capsules twice daily
BI 671800 (high dose)	Fluticasone propionate placebo	Patients receive BI 671800 (high dose) capsules twice daily
Placebo	Fluticasone propionate placebo	Patients receive placebo capsules twice daily
Fluticasone propionate	Fluticasone propionate	Patients inhale from Fluticasone propionate metered dose inhaler (MDI) twice daily

Primary Outcome Measures

Name	Time	Method
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	Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.	Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit.; MMRM in the statistical test comments is mixed effects model with repeated measures.

Secondary Outcome Measures

Name	Time	Method
Asthma Control Questionnaire (ACQ) Mean Score Change From Baseline After Six Weeks of Treatment	Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.	Asthma Control Questionnaire (ACQ) mean score change from baseline (mean ACQ score obtained at Week 0) after six weeks of treatment.; The Asthma Control Questionnaire (ACQ) is a patient-reported outcome questionnaire containing 7 items. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore between 0 (well controlled) and 6 (extremely poorly controlled) These questions based on recall of the previous 7 days comprise breathlessness, nocturnal waking, symptoms on waking, activity limitation, wheeze, frequency of short-acting beta-adrenergic (SABA) use, and categorized pre-bronchodilator FEV1% predicted.

Trial Locations

Locations (92)

1268.17.02003 Boehringer Ingelheim Investigational Site; 🇨🇦 Toronto, Ontario, Canada

1268.17.01034 Boehringer Ingelheim Investigational Site; 🇺🇸 Baltimore, Maryland, United States

1268.17.01027 Boehringer Ingelheim Investigational Site; 🇺🇸 Novi, Michigan, United States

1268.17.01011 Boehringer Ingelheim Investigational Site; 🇺🇸 Raleigh, North Carolina, United States

1268.17.01006 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1268.17.01031 Boehringer Ingelheim Investigational Site; 🇺🇸 Easley, South Carolina, United States

1268.17.01004 Boehringer Ingelheim Investigational Site; 🇺🇸 Cincinnati, Ohio, United States

1268.17.01035 Boehringer Ingelheim Investigational Site; 🇺🇸 San Antonio, Texas, United States

1268.17.01025 Boehringer Ingelheim Investigational Site; 🇺🇸 South Bend, Indiana, United States

1268.17.61001 Boehringer Ingelheim Investigational Site; 🇦🇺 Adelaide, South Australia, Australia

1268.17.01026 Boehringer Ingelheim Investigational Site; 🇺🇸 Greenville, South Carolina, United States

1268.17.01012 Boehringer Ingelheim Investigational Site; 🇺🇸 El Paso, Texas, United States

1268.17.01039 Boehringer Ingelheim Investigational Site; 🇺🇸 Fort Mill, South Carolina, United States

1268.17.02010 Boehringer Ingelheim Investigational Site; 🇨🇦 Mississauga, Ontario, Canada

1268.17.01023 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

1268.17.01016 Boehringer Ingelheim Investigational Site; 🇺🇸 Lakewood, Colorado, United States

1268.17.01032 Boehringer Ingelheim Investigational Site; 🇺🇸 Minneapolis, Minnesota, United States

1268.17.01036 Boehringer Ingelheim Investigational Site; 🇺🇸 Normal, Illinois, United States

1268.17.01005 Boehringer Ingelheim Investigational Site; 🇺🇸 Iowa City, Iowa, United States

1268.17.01037 Boehringer Ingelheim Investigational Site; 🇺🇸 Saint Louis, Missouri, United States

1268.17.01028 Boehringer Ingelheim Investigational Site; 🇺🇸 New Braunfels, Texas, United States

1268.17.01042 Boehringer Ingelheim Investigational Site; 🇺🇸 Philadelphia, Pennsylvania, United States

1268.17.02001 Boehringer Ingelheim Investigational Site; 🇨🇦 Quebec, Canada

1268.17.82007 Boehringer Ingelheim Investigational Site; 🇰🇷 Cheongju, Korea, Republic of

1268.17.01049 Boehringer Ingelheim Investigational Site; 🇺🇸 Spartanburg, South Carolina, United States

1268.17.01048 Boehringer Ingelheim Investigational Site; 🇺🇸 Killeen, Texas, United States

1268.17.64002 Boehringer Ingelheim Investigational Site; 🇳🇿 Newtown Wellington NZ, New Zealand

1268.17.82001 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1268.17.64001 Boehringer Ingelheim Investigational Site; 🇳🇿 Christchurch, New Zealand

1268.17.51003 Boehringer Ingelheim Investigational Site; 🇵🇪 Jesús María, Peru

1268.17.86208 Boehringer Ingelheim Investigational Site; 🇨🇳 Taichung, Taiwan

1268.17.02004 Boehringer Ingelheim Investigational Site; 🇨🇦 Quebec, Canada

1268.17.82006 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1268.17.64003 Boehringer Ingelheim Investigational Site; 🇳🇿 Greenlane East Auckland, New Zealand

1268.17.51005 Boehringer Ingelheim Investigational Site; 🇵🇪 Santiago de Surco, Peru

1268.17.86201 Boehringer Ingelheim Investigational Site; 🇨🇳 Taipei, Taiwan

1268.17.86206 Boehringer Ingelheim Investigational Site; 🇨🇳 Taipei, Taiwan

1268.17.01001 Boehringer Ingelheim Investigational Site; 🇺🇸 Denver, Colorado, United States

1268.17.01038 Boehringer Ingelheim Investigational Site; 🇺🇸 Oklahoma City, Oklahoma, United States

1268.17.52002 Boehringer Ingelheim Investigational Site; 🇲🇽 Cuernavaca, Mexico

1268.17.63002 Boehringer Ingelheim Investigational Site; 🇵🇭 Manila, Philippines

1268.17.63004 Boehringer Ingelheim Investigational Site; 🇵🇭 Quezon City, Philippines

1268.17.86210 Boehringer Ingelheim Investigational Site; 🇨🇳 Chiayi City, Taiwan

1268.17.86207 Boehringer Ingelheim Investigational Site; 🇨🇳 Taichung, Taiwan

1268.17.51004 Boehringer Ingelheim Investigational Site; 🇵🇪 San Isidro., Peru

1268.17.63007 Boehringer Ingelheim Investigational Site; 🇵🇭 Caloocan City, Philippines

1268.17.86209 Boehringer Ingelheim Investigational Site; 🇨🇳 Taichung, Taiwan

1268.17.01022 Boehringer Ingelheim Investigational Site; 🇺🇸 Bozeman, Montana, United States

1268.17.86205 Boehringer Ingelheim Investigational Site; 🇨🇳 Taipei, Taiwan

1268.17.86200 Boehringer Ingelheim Investigational Site; 🇨🇳 Taoyuan County, Taiwan

1268.17.86202 Boehringer Ingelheim Investigational Site; 🇨🇳 Taipei, Taiwan

1268.17.57004 Boehringer Ingelheim Investigational Site; 🇨🇴 Bogotá, Colombia

1268.17.52001 Boehringer Ingelheim Investigational Site; 🇲🇽 Monterrey, Mexico

1268.17.51002 Boehringer Ingelheim Investigational Site; 🇵🇪 Lima, Peru

1268.17.63003 Boehringer Ingelheim Investigational Site; 🇵🇭 Quezon City, Philippines

1268.17.86211 Boehringer Ingelheim Investigational Site; 🇨🇳 Kaohsiung City, Taiwan

1268.17.86203 Boehringer Ingelheim Investigational Site; 🇨🇳 Taipei, Taiwan

1268.17.86204 Boehringer Ingelheim Investigational Site; 🇨🇳 Taipei, Taiwan

1268.17.02012 Boehringer Ingelheim Investigational Site; 🇨🇦 Hawkesbury, Ontario, Canada

1268.17.82003 Boehringer Ingelheim Investigational Site; 🇰🇷 Suwon, Korea, Republic of

1268.17.01010 Boehringer Ingelheim Investigational Site; 🇺🇸 Saint Louis, Missouri, United States

1268.17.01029 Boehringer Ingelheim Investigational Site; 🇺🇸 Greenville, South Carolina, United States

1268.17.82002 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1268.17.01019 Boehringer Ingelheim Investigational Site; 🇺🇸 Dallas, Texas, United States

1268.17.82004 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1268.17.82005 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1268.17.01043 Boehringer Ingelheim Investigational Site; 🇺🇸 Tucson, Arizona, United States

1268.17.01009 Boehringer Ingelheim Investigational Site; 🇺🇸 Cypress, California, United States

1268.17.01033 Boehringer Ingelheim Investigational Site; 🇺🇸 Wheat Ridge, Colorado, 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

1268.17.01045 Boehringer Ingelheim Investigational Site; 🇺🇸 DeLand, Florida, United States

1268.17.01015 Boehringer Ingelheim Investigational Site; 🇺🇸 Colorado Springs, Colorado, United States

1268.17.01003 Boehringer Ingelheim Investigational Site; 🇺🇸 Stockton, California, United States

1268.17.01030 Boehringer Ingelheim Investigational Site; 🇺🇸 North Dartmouth, Massachusetts, United States

1268.17.01008 Boehringer Ingelheim Investigational Site; 🇺🇸 Bellevue, Nebraska, United States

1268.17.01014 Boehringer Ingelheim Investigational Site; 🇺🇸 North Dartmouth, Massachusetts, United States

1268.17.01007 Boehringer Ingelheim Investigational Site; 🇺🇸 Charleston, South Carolina, United States

1268.17.01047 Boehringer Ingelheim Investigational Site; 🇺🇸 Tacoma, Washington, United States

1268.17.02013 Boehringer Ingelheim Investigational Site; 🇨🇦 Toronto, Ontario, Canada

1268.17.02014 Boehringer Ingelheim Investigational Site; 🇨🇦 Newmarket, Ontario, Canada

1268.17.57002 Boehringer Ingelheim Investigational Site; 🇨🇴 Medellín, Colombia

1268.17.02015 Boehringer Ingelheim Investigational Site; 🇨🇦 Sudbury, Ontario, Canada

1268.17.57003 Boehringer Ingelheim Investigational Site; 🇨🇴 Bogotá, Colombia

1268.17.82008 Boehringer Ingelheim Investigational Site; 🇰🇷 Wonju, Korea, Republic of

1268.17.52004 Boehringer Ingelheim Investigational Site; 🇲🇽 Toriello Guerra, Mexico

1268.17.52003 Boehringer Ingelheim Investigational Site; 🇲🇽 Zona Río, Mexico

1268.17.51001 Boehringer Ingelheim Investigational Site; 🇵🇪 Urb. Ingeniería, Peru

1268.17.51006 Boehringer Ingelheim Investigational Site; 🇵🇪 San Borja, Peru

1268.17.63001 Boehringer Ingelheim Investigational Site; 🇵🇭 Quezon City, Philippines

1268.17.63005 Boehringer Ingelheim Investigational Site; 🇵🇭 Quezon City, Philippines

1268.17.63006 Boehringer Ingelheim Investigational Site; 🇵🇭 Quezon City, Philippines