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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Placebo device for comparison
Olodaterol comparison of low, medium low, medium high and high doses
Olodaterol comparison of low, medium low, medium high and high doses
1222.4.103 UBC - Respiratory Medicine
Vancouver, British Columbia, Canada
1222.4.104 Department of Medicine, Health Sciences Centre
Hamilton, Ontario, Canada
1222.4.101 2725 Chemin Ste Foy
Sainte-Foy, Quebec, Canada
1222.4.102
Saskatoon, Saskatchewan, Canada
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours
Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours
Time frame: 24 hours post dose
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes
Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes
Time frame: 30 minutes post dose
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours
Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours
Time frame: 4 hours post dose
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours
Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours
Time frame: 8 hours post dose
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours
Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours
Time frame: 32 hours post dose
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
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).
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Olodaterol comparison of low, medium low, medium high and high doses
Olodaterol comparison of low, medium low, medium high and high doses
Time frame: 5 days
Laboratory Testing: Average Change From Baseline of Potassium and Calcium
Laboratory testing: Average change from baseline of potassium and calcium measured on test-days
Time frame: Baseline to Visit 6