Randomised, Double-Blind, Placebo-Controlled, 5-Way Cross-Over Study to Assess the Efficacy (Bronchoprotection) and Safety of a Single Dose of Orally Inhaled BI 1744 CL (2, 5, 10 and 20ug) in Patients With Intermittent Asthma
Overview
- Phase
- Phase 2
- Intervention
- Olodaterol (BI1744CL)
- Conditions
- Asthma
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 32
- Locations
- 4
- Primary Endpoint
- Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Olodaterol (BI1744) Low
Single dosing of low dose Olodaterol inhaled orally from Respimat Device
Intervention: Olodaterol (BI1744CL)
Olodaterol (BI1744) Medium Low
Single dosing of medium low dose Olodaterol inhaled orally from Respimat Device
Intervention: Olodaterol (BI1744CL)
Olodaterol (BI1744) Medium High
Single dosing of medium high dose Olodaterol inhaled orally from Respimat Device
Intervention: Olodaterol (BI1744CL)
Olodaterol (BI 1744) High
Single dosing of high dose Olodaterol inhaled orally from Respimat Device
Intervention: Olodaterol (BI1744CL)
Placebo
Single dosing of Olodaterol placebo inhaled orally from Respimat Device
Intervention: Placebo
Outcomes
Primary Outcomes
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours
Time Frame: 24 hours post dose
Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours
Secondary Outcomes
- Laboratory Testing: Average Change From Baseline of Potassium and Calcium(Baseline to Visit 6)
- Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes(30 minutes post dose)
- Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours(4 hours post dose)
- Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours(8 hours post dose)
- Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours(32 hours post dose)
- Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG(5 days)