BI 671800 ED in Steroid-naive Asthmatic Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: BI 671800
* Drug: Fluticasone propionate placebo
* Drug: Fluticasone propionate
* Drug: BI 671800 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Signed informed consent consistent with ICH-GCP Three month history of reversible (12% with 200 mL) asthma (according to GINA) with following spirometry at randomization: FEV1 60%-85%. No ICS previous 3 months prior to screening. Diagnosis of asthma prior to 40 years. 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 PFT Exclusion criteria: Significant diseases other than asthma or allergic rhinitis. Hepatic transaminases or total bilirubin greater than 1.5 ULN. Hospitalizations for asthma or asthma related intubation within 3 months. Uncontrolled asthma. Respiratory tract infection or exacerbation within 4 weeks. FEV1 less than 40%, more than 12 puffs of 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 671800 (low dose)<br>Patients receive BI 671800 (low dose) capsules twice daily | Drug: BI 671800<br>* BI 671800<br>Drug: Fluticasone propionate placebo<br>* Placebo matching Fluticasone propionate<br>|
| Active Comparator: Fluticasone propionate<br>Patients inhale from Fluticasone propionate metered dose inhaler (MDI) twice daily | Drug: Fluticasone propionate<br>* Fluticasone propionate<br>Drug: BI 671800 Placebo<br>* Placebo matching BI 671800<br>|
| Placebo Comparator: Placebo<br>Patients receive placebo capsules twice daily | Drug: Fluticasone propionate placebo<br>* Placebo matching Fluticasone propionate<br>Drug: BI 671800 Placebo<br>* Placebo matching BI 671800<br>|
| Experimental: BI 671800 (medium dose)<br>Patients receive BI 671800 (medium dose) capsules twice daily | Drug: BI 671800<br>* BI 671800<br>Drug: Fluticasone propionate placebo<br>* Placebo matching Fluticasone propionate<br>|
| Experimental: BI 671800 (high dose)<br>Patients receive BI 671800 (high dose) capsules twice daily | Drug: BI 671800<br>* BI 671800<br>Drug: Fluticasone propionate placebo<br>* Placebo matching Fluticasone propionate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Questionnaire (ACQ) Mean Score Change From Baseline After Six Weeks 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. | Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment. |