BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

Study Overview
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Brief Summary
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This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main objective is to assess the effect on lung function. The study will also provide data on the pharmacokinetics of BI 671800.

Official Title
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Randomised, Double Blind, Double Dummy, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 6 Weeks of Oral BI 671800 ED Twice Daily (b.i.d.), Montelukast Once Daily (q.d.) or Placebo in Symptomatic Asthmatic Patients on Low Dose Fluticasone Propionate MDI (Metered Dose Inhaler)

Conditions
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Asthma

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


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% and 200 mL in forced expiratory volume in one second - FEV1) asthma (according to GINA) with following spirometry at randomisation: FEV1 60%- 85%. Stable inhaled corticosteroids (iCS) dose 3 months prior to screening. Diagnosis of asthma prior to 40 years. Asthma Control Questionnaire (ACQ) at least 1.5 at randomisation. Male or female 18 to 65 years. Non-smokers or ex-smokers (less than 10 pack years history) with negative cotinine screen. Able to perform pulmonary function testing. Exclusion criteria: Significant diseases other than asthma or allergic rhinitis. Hepatic transaminases or total bilirubin greater than 1.5 ULN. Hospitalisation for asthma exacerbation or asthma related intubation within 3 months. Uncontrolled asthma on iCS + other controller. Respiratory tract infection or exacerbation within 4 weeks. FEV1 less than 40%, more than 12 puffs rescue salbutamol on more than two consecutive days, or asthma exacerbation during run-in period. Participation in another interventional study. Pregnant or nursing women. Women of child bearing potential not using appropriate methods of birth control as defined by the study 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<br>Patients receive BI 671800 capsules twice daily | Drug: BI 671800<br>* Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma<br>|
| Active Comparator: Montelukast<br>Patients receive Montelukast encapsulated tablets once daily | Drug: Montelukast<br>* Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma<br>|
| Placebo Comparator: Placebo<br>Patients receive placebo capsules and/or encapsulated placebo tablets | Drug: Placebo<br>* Patients receive placebo capsules and/or encapsulated tablets<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 Change in Score on a Scale 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. |