Study on BI 54903 (Inhaled Corticosteroid) Administered Once Daily or Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Low Dose Inhaled Corticosteroids

Phase 2

Withdrawn

• Conditions: Asthma
• Interventions: Drug: Placebo matching Respimat; Drug: BI 54903 MD; Drug: BI 54903 HD

• Registration Number: NCT01458912
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-25
• Status Verified: 2011-11
• Study Start: 2011-11
• Last Update Submitted: 2011-11-21
• Last Update Posted: 2011-11-23
• Primary Completion: 2013-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 54903 HD q.d.	Placebo matching Respimat	Patients receive 2 puffs BI 54903 HD q.d. via Respimat inhaler (p.m.) combined with 2 puffs placebo (a.m.)
BI 54903 HD q.d.	BI 54903 HD	Patients receive 2 puffs BI 54903 HD q.d. via Respimat inhaler (p.m.) combined with 2 puffs placebo (a.m.)
Placebo	Placebo matching Respimat	Patients receive 2 puffs Placebo b.i.d. via Respimat inhaler
BI 54903 MD b.i.d.	BI 54903 MD	Patients receive 2 puffs BI 54903 MD b.i.d.via Respimat inhaler

Primary Outcome Measures

Name	Time	Method
Mean change from randomisation baseline to the end of the 12-week treatment period in evening trough (pre-dose and pre-rescue bronchodilator) FEV1	12 weeks

Secondary Outcome Measures

Name	Time	Method
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