Study on BI 54903 (Inhaled Corticosteroid) Administered Once Daily or Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Short Acting Beta-2 Agonist (SABA) Therapy Alone

Phase 2

Withdrawn

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

• Registration Number: NCT01458886
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The aim of this study is to assess and compare efficacy and safety of BI 54903 at doses of very low dose twice daily (b.i.d) and low dose once daily (evening dosing) and placebo over an 12-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on short acting beta-2 agonist (SABA) therapy alone as demonstrated by a decrease in forced expiratory volume in 1 second (FEV1) (not less than 10 %, and equal to or less than 25%) and an Asthma Control Questionnaire (ACQ-6) 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
• Study Start: 2011-11
• Primary Completion: 2013-05
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31

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• Status: WITHDRAWN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 LD b.i.d.	BI 54903	Patients receive 2 puffs b.i.d. via Respimat inhaler
BI 54903 MD q.d.	BI 54903 MD	Patients receive 2 puffs q.d. via Respimat inhaler (p.m.) combined with 2 puffs placebo (a.m.)
BI 54903 MD q.d.	Placebo matching Respimat	Patients receive 2 puffs q.d. via Respimat inhaler (p.m.) combined with 2 puffs placebo (a.m.)
Placebo	Placebo matching Respimat	Patients receive 2 puffs 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
Daytime 12-h FEV1 profiles after 12-week treatment period (FEV1 AUC0-12h)	12 weeks
Asthma control questionnaire (ACQ-6)	12 weeks
Mean change from randomisation baseline in morning and evening trough (pre-dose and pre-rescue bronchodilator) FEF25-75 after 2, 4, 8 and 12 week treatment periods	2, 4, 8 and 12 weeks
Asthma quality of life questionnaire (AQLQ(S)+12)	12 weeks
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) 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) PEF as assessed via 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
Time to withdrawal due to first asthma exacerbation	12weeks