Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: BI 671800
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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). Exclusion criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 671800 AM and PM<br>Patients receiving two capsules twice daily | Drug: BI 671800<br>* BI 671800<br>|
| Experimental: BI 671800 AM<br>Patients receiving four capsules in the morning | Drug: BI 671800<br>* BI 671800<br>|
| Experimental: BI 671800 PM<br>Patients receiving four capsules in the evening | Drug: BI 671800<br>* BI 671800<br>|
| Placebo Comparator: Placebo<br>Patients receiving four capsules twice a day | Drug: Placebo<br>* Placebo matching BI 671800<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Asthma Control Questionnaire (ACQ) Mean Score After Four Weeks of Treatment | 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. | At baseline and 4 weeks |