The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat inhaler once daily for 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
328
2 puffs of 1 µg/actuation delivered by the Respimat® inhaler
2 puffs of 2.5 µg/actuation delivered by the Respimat® inhaler
2 puffs of 5 µg/actuation delivered by Respimat®
Trough FEV1 Response at Week 4
The change from baseline in trough FEV1 after 4 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline . Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication.
Time frame: baseline and after 4 weeks treatment
Trough FEV1 Response at Week 2
Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication
Time frame: baseline and after 2 weeks treatment
FEV1 AUC(0-3) Response at 4 Weeks
The change from baseline in FEV1 AUC(0-3) after 4 weeks of treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters. Due to normalization the unit is liters.
Time frame: baseline and after 4 weeks treatment
FEV1 Peak(0-3) Response at 4 Weeks
The change from baseline in FEV1 peak(0-3) after 4 weeks of treatment.
Time frame: baseline and after 4 weeks treatment
Trough FVC Response at Week 4
The change from baseline in Trough FVC after 4 weeks of treatment
Time frame: baseline and after 4 weeks treatment
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2 puffs delivered by the Respimat® inhaler
1222.22.048 Boehringer Ingelheim Investigational Site
Asahikawa, Hokkaido, Japan
1222.22.044 Boehringer Ingelheim Investigational Site
Bunkyo-ku, Tokyo, Japan
1222.22.008 Boehringer Ingelheim Investigational Site
Chiba, Chiba, Japan
1222.22.002 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka, Japan
1222.22.041 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka, Japan
1222.22.027 Boehringer Ingelheim Investigational Site
Himeji, Hyogo, Japan
1222.22.028 Boehringer Ingelheim Investigational Site
Himeji, Hyogo, Japan
1222.22.018 Boehringer Ingelheim Investigational Site
Hiroshima, Hiroshima, Japan
1222.22.021 Boehringer Ingelheim Investigational Site
Hitachi, Ibaraki, Japan
1222.22.010 Boehringer Ingelheim Investigational Site
Inashiki-gun, Ibaraki, Japan
...and 38 more locations
FVC AUC(0-3) Response
The change from baseline in FVC AUC(0-3) response after 4 weeks of treatment. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters. Due to normalization the unit is liters.
Time frame: baseline and after 4 weeks treatment
FVC Peak(0-3) Response
The change from baseline in FVC peak(0-3) response after 4 weeks of treatment.
Time frame: baseline and after 4 weeks treatment
Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 0-6h (AUC 0-6h) Response After 4 Weeks
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters.
Time frame: baseline and after 4weeks treatment
Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters.
Time frame: Baseline and after 4weeks treatment
Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks
PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs, Morning measurements were performed immediately upon arising before administration of trial and/or rescue medication.The highest of three readings for each measurement were recorded.
Time frame: Week 4
Weekly Mean Evening PEFR After 4 Weeks
PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs, Evening measurements were performed at bedtime.The highest of three readings for each measurement were recorded.
Time frame: Week 4
Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks
Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol )
Time frame: Week 4
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination
Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical examination. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).
Time frame: 4 weeks
Difference From Baseline in Potassium
Difference from baseline in Potassium (normalized values). Normalization means that the values from different laboratories are transformed in such a way that they are directly comparable.
Time frame: Baseline, Week 4
Cmax (Maximum Measured Concentration of the Analyte in Plasma)
Cmax only calculated if \>1/3 of the patients have available pharmacokinetic parameters,thus not applicable for the Olodaterol 2 mcg
Time frame: after first inhalated administration
Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State)
Cmax,ss only calculated if \>1/3 of the patients have available pharmacokinetic parameters, thus not applicable for the Olodaterol 2 mcg
Time frame: visit at week 4
AUC0-1
Area under the concentration curve from 0 to 1 hour using trapezoid rule, only calculated if \>1/3 of the patients have available pharmacokinetic parameters,thus not applicable for Olodaterol 2mcg group
Time frame: after first inhalated administration
AUC0-1,ss
Area under the concentration curve from 0 to 1 hour at steady state using trapezoid rule, only calculated if \>1/3 of the patients have available pharmacokinetic parameters, thus not applicable for Olodaterol 2mcg group
Time frame: visit at week 4