Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: BI 671800; Drug: Placebo

• Registration Number: NCT01090024
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-03-01
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-18
• Study First Posted: 2010-03-19
• Primary Completion: 2011-02-01
• Study Completion: 2011-02-18
• 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: 2022-05-10
• Last Update Submitted: 2022-05-10
• Results First Posted: 2022-05-11
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BI 671800 AM and PM	BI 671800	Patients receiving two capsules twice daily
BI 671800 AM	BI 671800	Patients receiving four capsules in the morning
BI 671800 PM	BI 671800	Patients receiving four capsules in the evening
Placebo	Placebo	Patients receiving four capsules twice a day

Primary Outcome Measures

Name	Time	Method
Change From Baseline of Trough Forced Expiratory Volume in One Second (FEV1) Percent Predicted After 4 Weeks of Treatment	At baseline and 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Asthma Control Questionnaire (ACQ) Mean Score After Four Weeks of Treatment	At baseline and 4 weeks	The Asthma Control Questionnaire (ACQ) consists of 6 patient self-evaluated questions and 1 by clinical staff with each question in 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of less than or equal to 0.75 indicate well-controlled asthma, scores between 0.76 and less than 1.5 indicate partly controlled asthma, and a score greater than or equal to 1.5 indicates uncontrolled asthma.

Trial Locations

Locations (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

1268.53.01001 Boehringer Ingelheim Investigational Site; 🇺🇸 North Dartmouth, Massachusetts, 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

1268.53.01007 Boehringer Ingelheim Investigational Site; 🇺🇸 Raleigh, North Carolina, United States

1268.53.01005 Boehringer Ingelheim Investigational Site; 🇺🇸 Minneapolis, Minnesota, United States

1268.53.01006 Boehringer Ingelheim Investigational Site; 🇺🇸 Saint Louis, Missouri, 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

1268.53.01012 Boehringer Ingelheim Investigational Site; 🇺🇸 San Antonio, Texas, United States

1268.53.01011 Boehringer Ingelheim Investigational Site; 🇺🇸 Denver, Colorado, United States

1268.53.01015 Boehringer Ingelheim Investigational Site; 🇺🇸 Richmond, Virginia, United States

1268.53.01008 Boehringer Ingelheim Investigational Site; 🇺🇸 El Paso, Texas, United States