The objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC \[2.5/ 5µg and 5/ 5µg\] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC \[250/50µg and 500/50µg\] delivered by the Accuhaler® after 6 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
229
FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 12hours post-dose (AUC 0-12h) \[L\] after 6 weeks of treatment. Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
Time frame: Baseline and 6 weeks.
FEV1 AUC (0-24h) Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 24 hours post-dose (AUC 0-24h) \[L\] after 6 weeks of treatment. Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
Time frame: Baseline and 6 weeks.
Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Trough Forced Expiratory Volume in one second (FEV1) after 6 weeks of treatment. Trough FEV1 was defined as the mean of the 23h and 23h 50min (minutes) post-dose FEV1 measurements. Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
Time frame: Baseline and 6 weeks.
FEV1 AUC (12-24h) Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 12 to 24 hours post-dose (AUC 12-24h) \[L\] after 6 weeks of treatment. Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
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placebo/dummy for blinding purposes
tiotropium high dose
placebo/dummy for blinding purposes
placebo/dummy for blinding purposes
tiotropium low dose
low dose
1237.11.32002 Boehringer Ingelheim Investigational Site
Genk, Belgium
1237.11.32001 Boehringer Ingelheim Investigational Site
Ghent, Belgium
1237.11.42003 Boehringer Ingelheim Investigational Site
Kyjov, Czechia
1237.11.42004 Boehringer Ingelheim Investigational Site
Rokycany, Czechia
1237.11.42002 Boehringer Ingelheim Investigational Site
Tábor, Czechia
1237.11.42001 Boehringer Ingelheim Investigational Site
Třebíč, Czechia
1237.11.45002 Boehringer Ingelheim Investigational Site
Hvidovre, Denmark
1237.11.45004 Boehringer Ingelheim Investigational Site
Kolding, Denmark
1237.11.45001 Boehringer Ingelheim Investigational Site
Odense C, Denmark
1237.11.45003 Boehringer Ingelheim Investigational Site
Silkeborg, Denmark
...and 19 more locations
Time frame: Baseline and 6 weeks.
FEV1 Peak (0-3h) Change From Patient Baseline After 6 Weeks of Treatment
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) peak (0-3 hours) after 6 weeks of treatment. FEV1 peak (0-3 hours) was defined as the maximum FEV1 value measured within the first three hours post dosing. Measured values presented are actually adjusted means.
Time frame: Baseline and 6 weeks.