A Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess and Compare Efficacy and Safety of a 12-week Treatment With BI 54903 at Doses of 181.8 Mcg b.i.d. and 363.6 Mcg q.d. (p.m. Dosing) Administered Via Respimat® Inhaler in Patients With Asthma Inadequately Controlled on Low Dose ICS Therapy
Overview
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Boehringer Ingelheim
- Primary Endpoint
- Mean change from randomisation baseline to the end of the 12-week treatment period in evening trough (pre-dose and pre-rescue bronchodilator) FEV1
Overview
Brief Summary
The aim of this study is to assess and compare efficacy and safety of BI 54903 at medium doses twice daily and high doses once daily (evening dosing) and placebo over an 12-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on low dose inhaled corticosteroid (ICS) therapy as demonstrated by a decrease in Forced Expiratory Volume in one second (FEV1) (not less than 10 %, and equal to or less than 25%) and an Asthma Control Questionnaire (ACQ)-6 score of not less than 1.5 at time of randomisation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 12 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 54903 HD q.d.
Patients receive 2 puffs BI 54903 HD q.d. via Respimat inhaler (p.m.) combined with 2 puffs placebo (a.m.)
Intervention: Placebo matching Respimat (Drug)
BI 54903 HD q.d.
Patients receive 2 puffs BI 54903 HD q.d. via Respimat inhaler (p.m.) combined with 2 puffs placebo (a.m.)
Intervention: BI 54903 HD (Drug)
Placebo
Patients receive 2 puffs Placebo b.i.d. via Respimat inhaler
Intervention: Placebo matching Respimat (Drug)
BI 54903 MD b.i.d.
Patients receive 2 puffs BI 54903 MD b.i.d.via Respimat inhaler
Intervention: BI 54903 MD (Drug)
Outcomes
Primary Outcomes
Mean change from randomisation baseline to the end of the 12-week treatment period in evening trough (pre-dose and pre-rescue bronchodilator) FEV1
Time Frame: 12 weeks
Secondary Outcomes
- Mean change from randomisation baseline to the end of the 12-week treatment period in morning and evening trough (pre-dose and pre-rescue bronchodilator) Forced Vital Capacity (FVC)(12 weeks)
- Mean change from randomisation baseline in morning and evening trough (pre-dose and pre-rescue bronchodilator) FEV1 and FVC after 2, 4 and 8-week treatment periods, and in morning trough FEV1 after 12 week treatment period(12 weeks)
- Mean pre-dose (and pre-rescue) Peak Expiratory Flow (PEF) as assessed via Asthma Monitor2+ (AM2+) device (in the morning and evening) of the last week of the 12-week treatment period(12 weeks)
- Mean rescue medication use (daytime and night-time) as assessed via AM2+ device (in the morning and evening) of the last week of the 12-week treatment period(12 weeks)
- Asthma control questionnaire (ACQ-6).(12 weeks)
- Asthma quality of life questionnaire (AQLQ(S)+12)(12 weeks)
- Time to withdrawal due to first asthma exacerbation(12 weeks)
- Daytime 12-h FEV1 profiles after 12-week treatment period (FEV1 Area Under Curve (AUC) 0-12h)(12 weeks)