Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT01969721
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 229
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ICS/LABA FDC Dosage 1 fluticasone propionate Low dose T+O FDC dosage 2 placebo High dose T+O FDC dosage 2 olodaterol High dose T+O FDC dosage 1 olodaterol Low dose T+O FDC dosage 1 placebo Low dose ICS/LABA FDC Dosage 1 placebo Low dose T+O FDC dosage 1 tiotropium Low dose T+O FDC dosage 2 tiotropium High dose ICS/LABA FDC Dosage 2 fluticasone propionate High dose ICS/LABA FDC Dosage 2 placebo High dose ICS/LABA FDC Dosage 2 salmeterol High dose ICS/LABA FDC Dosage 1 salmeterol Low dose
- Primary Outcome Measures
Name Time Method FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment Baseline and 6 weeks. 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.
- Secondary Outcome Measures
Name Time Method FEV1 AUC (0-24h) Change From Patient Baseline After 6 Weeks of Treatment Baseline and 6 weeks. 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.Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment Baseline and 6 weeks. 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.FEV1 AUC (12-24h) Change From Patient Baseline After 6 Weeks of Treatment Baseline and 6 weeks. 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.FEV1 Peak (0-3h) Change From Patient Baseline After 6 Weeks of Treatment Baseline and 6 weeks. 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.
Trial Locations
- Locations (29)
1237.11.42004 Boehringer Ingelheim Investigational Site
🇨🇿Rokycany, Czech Republic
1237.11.49003 Boehringer Ingelheim Investigational Site
🇩🇪Großhansdorf, Germany
1237.11.49005 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1237.11.49001 Boehringer Ingelheim Investigational Site
🇩🇪Mannheim, Germany
1237.11.49004 Boehringer Ingelheim Investigational Site
🇩🇪Mönchengladbach, Germany
1237.11.49002 Boehringer Ingelheim Investigational Site
🇩🇪Wiesbaden, Germany
1237.11.31005 Boehringer Ingelheim Investigational Site
🇳🇱Almelo, Netherlands
1237.11.31006 Boehringer Ingelheim Investigational Site
🇳🇱Eindhoven, Netherlands
1237.11.31001 Boehringer Ingelheim Investigational Site
🇳🇱Heerlen, Netherlands
1237.11.31007 Boehringer Ingelheim Investigational Site
🇳🇱Hoorn, Netherlands
1237.11.34001 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1237.11.46001 Boehringer Ingelheim Investigational Site
🇸🇪Lund, Sweden
1237.11.34003 Boehringer Ingelheim Investigational Site
🇪🇸Alicante, Spain
1237.11.34002 Boehringer Ingelheim Investigational Site
🇪🇸Pozuelo de Alarcón, Spain
1237.11.32001 Boehringer Ingelheim Investigational Site
🇧🇪Gent, Belgium
1237.11.42003 Boehringer Ingelheim Investigational Site
🇨🇿Kyjov, Czech Republic
1237.11.36002 Boehringer Ingelheim Investigational Site
🇭🇺Szombathely, Hungary
1237.11.42001 Boehringer Ingelheim Investigational Site
🇨🇿Trebic, Czech Republic
1237.11.36003 Boehringer Ingelheim Investigational Site
🇭🇺Szeged, Hungary
1237.11.36004 Boehringer Ingelheim Investigational Site
🇭🇺Pecs, Hungary
1237.11.31002 Boehringer Ingelheim Investigational Site
🇳🇱Breda, Netherlands
1237.11.42002 Boehringer Ingelheim Investigational Site
🇨🇿Tabor, Czech Republic
1237.11.36001 Boehringer Ingelheim Investigational Site
🇭🇺Debrecen, Hungary
1237.11.31003 Boehringer Ingelheim Investigational Site
🇳🇱Zutphen, Netherlands
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
1237.11.45002 Boehringer Ingelheim Investigational Site
🇩🇰Hvidovre, Denmark
1237.11.32002 Boehringer Ingelheim Investigational Site
🇧🇪Genk, Belgium