Efficacy (Bronchoprotection) and Safety of Orally Inhaled BI 1744 CL in Patients With Intermittent Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Olodaterol (BI1744CL); Drug: Placebo

• Registration Number: NCT00928668
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this study is to assess the efficacy (bronchoprotection) and safety of single doses of BI 1744 CL inhalation solution (2, 5, 10 and 20 mcg) delivered via the Respimat® inhaler, in patients with intermittent asthma.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2006-10
• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Results First Submitted: 2014-03-28
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-29
• Last Update Submitted: 2014-05-29
• Results First Posted: 2014-07-01
• Last Update Posted: 2014-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Olodaterol (BI1744) Low	Olodaterol (BI1744CL)	Single dosing of low dose Olodaterol inhaled orally from Respimat Device
Olodaterol (BI1744) Medium Low	Olodaterol (BI1744CL)	Single dosing of medium low dose Olodaterol inhaled orally from Respimat Device
Olodaterol (BI1744) Medium High	Olodaterol (BI1744CL)	Single dosing of medium high dose Olodaterol inhaled orally from Respimat Device
Olodaterol (BI 1744) High	Olodaterol (BI1744CL)	Single dosing of high dose Olodaterol inhaled orally from Respimat Device
Placebo	Placebo	Single dosing of Olodaterol placebo inhaled orally from Respimat Device

Primary Outcome Measures

Name	Time	Method
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours	24 hours post dose	Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours

Secondary Outcome Measures

Name	Time	Method
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes	30 minutes post dose	Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours	4 hours post dose	Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours	8 hours post dose	Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG	5 days	Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours	32 hours post dose	Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours
Laboratory Testing: Average Change From Baseline of Potassium and Calcium	Baseline to Visit 6	Laboratory testing: Average change from baseline of potassium and calcium measured on test-days

Trial Locations

Locations (4)

1222.4.103 UBC - Respiratory Medicine; 🇨🇦 Vancouver, British Columbia, Canada

1222.4.102; 🇨🇦 Saskatoon, Saskatchewan, Canada

1222.4.104 Department of Medicine, Health Sciences Centre; 🇨🇦 Hamilton, Ontario, Canada

1222.4.101 2725 Chemin Ste Foy; 🇨🇦 Sainte-Foy, Quebec, Canada