Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease II
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT00796653
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 937
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olodaterol (BI 1744) Low Olodaterol (BI 1744) Low dose inhaled orally once daily from the Respimat inhaler Olodaterol (BI 1744) High Olodaterol (BI 1744) High dose inhaled orally once daily from the Respimat inhaler Formoterol 12mcg Formoterol 12mcg inhaled twice daily from the Aerolizer inhaler Placebo Placebo Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler and/or Formoterol placebo inhaled twice daily from the Aerolizer inhaler
- Primary Outcome Measures
Name Time Method Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis Baseline, Week 24 This outcome measure describes the combined analysis of the trials NCT00793624 and NCT00796653. Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24 Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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 litres.
Trough FEV1 Response at Week 24 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24. Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Mahler Transitional Dyspnea Index Focal Score at 24 Weeks Baseline, Week 24 Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
- Secondary Outcome Measures
Name Time Method Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48 Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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 litres.
Trough FEV1 Response at Week 12 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12. Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Trough FEV1 Response at Week 18 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18. Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis Baseline, Week 24 Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations). This is a combined analysis of the data from NCT00793624 and NCT00796653 showing adjusted values using a MMRM model.
Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2 Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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 litres.
Trough FEV1 Response at Week 6 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6. Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Trough FVC Response at Week 48 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48. Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Peak FVC (0-3h) Response After 12 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Patient's Global Rating (PGR) at 12 Weeks Week 12 Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).
Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks Baseline, Week 24 Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).
Trough FVC Response at Week 12 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12. Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Trough FVC Response at Week 18 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18. Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Peak FVC (0-3h) Response After 2 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks Baseline, Week 12 Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).
Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6 Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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 litres.
Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12 Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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 litres.
Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks Baseline, Week 48 Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).
Trough FEV1 Response at Week 2 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2. Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2 Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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 litres.
Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6 Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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 litres.
Trough FEV1 Response at Week 32 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32. Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Trough FEV1 Response at Week 40 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40. Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Trough FEV1 Response at Week 48 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48. Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Peak FEV1 (0-3h) Response After 2 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Peak FEV1 (0-3h) Response After 6 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Peak FEV1 (0-3h) Response After 12 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Peak FEV1 (0-3h) Response After 24 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Peak FEV1 (0-3h) Response After 48 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12 Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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 litres.
Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24 Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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 litres.
Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48 Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. 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 litres.
Trough FVC Response at Week 2 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2. Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Mahler Transitional Dyspnea Index Focal Score at 18 Weeks Baseline, Week 18 Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Mahler Transitional Dyspnea Index Focal Score at 32 Weeks Baseline, Week 32 Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Trough FVC Response at Week 6 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6. Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Trough FVC Response at Week 24 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24. Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Trough FVC Response at Week 32 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32. Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Trough FVC Response at Week 40 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40. Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Peak FVC (0-3h) Response After 6 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Peak FVC (0-3h) Response After 48 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Peak Expiratory Flow Rate (PEFR) at Week 24 Week 24 Weekly mean pre-dose morning and evening PEFR. Results are from non-MMRM ANCOVA models by week, with Last observation carried forward (LOCF) up to each week. Fixed effects include treatment, tiotropium, strata and baseline.
Use of Rescue Medication at Week 24 Week 24 Mean number of puffs of rescue medication used per day (daytime/nighttime/total)
Mahler Transitional Dyspnea Index Focal Score at 6 Weeks Baseline, Week 6 Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Peak FVC (0-3h) Response After 24 Weeks 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Patient's Global Rating (PGR) at 6 Weeks Week 6 Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).
Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization Baseline to end of study at 48 weeks. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.
Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Baseline to end of study at 48 weeks. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.
Patient's Global Rating (PGR) at 24 Weeks Week 24 Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).
Patient's Global Rating (PGR) at 48 Weeks Week 48 Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).
Mahler Transitional Dyspnea Index Focal Score at 12 Weeks Baseline, Week 12 Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Mahler Transitional Dyspnea Index Focal Score at 40 Weeks Baseline, Week 40 Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Mahler Transitional Dyspnea Index Focal Score at 48 Weeks Baseline, Week 48 Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Number of COPD Exacerbations Requiring Hospitalization Baseline to end of study at week 48 visit Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.
Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Baseline to end of study at 48 weeks. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.
Number of COPD Exacerbations Baseline to end of study at week 48 visit Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.
Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations Baseline to end of study at 48 weeks. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.
Changes in Safety Parameters Related to Treatment 48 weeks Occurence of cardiac disorders and investigations related to treatment.
Absolute Plasma Concentrations within 2 hours before first study drug administration and 10 minutes post-dose at week 6, 12 and 18 Absolute plasma concentrations of Olodaterol. Values presented are across visits and summarised into geometric means.
Trial Locations
- Locations (98)
1222.14.4007 Boehringer Ingelheim Investigational Site
🇨🇦Newmarket, Ontario, Canada
1222.14.4103 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt, Germany
1222.14.4301 Boehringer Ingelheim Investigational Site
🇮🇹Cassano Delle Murge (ba), Italy
1222.14.5106 Boehringer Ingelheim Investigational Site
🇧🇷Florianopolis, Brazil
1222.14.4108 Boehringer Ingelheim Investigational Site
🇩🇪Gelnhausen, Germany
1222.14.5004 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
1222.14.4112 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1222.14.4109 Boehringer Ingelheim Investigational Site
🇩🇪Mönchengladbach, Germany
1222.14.5002 Boehringer Ingelheim Investigational Site
🇦🇷Quilmes, Argentina
1222.14.5101 Boehringer Ingelheim Investigational Site
🇧🇷Porto Alegre, Brazil
1222.14.4107 Boehringer Ingelheim Investigational Site
🇩🇪Kelkheim, Germany
1222.14.4005 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1222.14.4304 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1222.14.4602 Boehringer Ingelheim Investigational Site
🇩🇰Helsingør, Denmark
1222.14.4111 Boehringer Ingelheim Investigational Site
🇩🇪Mainz, Germany
1222.14.4013 Boehringer Ingelheim Investigational Site
🇨🇦Ottawa, Ontario, Canada
1222.14.5001 Boehringer Ingelheim Investigational Site
🇦🇷Mendoza, Argentina
1222.14.5005 Boehringer Ingelheim Investigational Site
🇦🇷Florencio Varela, Argentina
1222.14.4104 Boehringer Ingelheim Investigational Site
🇩🇪Rodgau-Dudenhofen, Germany
1222.14.4302 Boehringer Ingelheim Investigational Site
🇮🇹Genova, Italy
1222.14.5304 Boehringer Ingelheim Investigational Site
🇰🇷Uijeongbu, Korea, Republic of
1222.14.4001 Boehringer Ingelheim Investigational Site
🇨🇦Scarborough, Ontario, Canada
1222.14.4110 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt, Germany
1222.14.4106 Boehringer Ingelheim Investigational Site
🇩🇪Aschaffenburg, Germany
1222.14.4305 Boehringer Ingelheim Investigational Site
🇮🇹Parma, Italy
1222.14.4503 Boehringer Ingelheim Investigational Site
🇸🇪Göteboerg, Sweden
1222.14.5301 Boehringer Ingelheim Investigational Site
🇰🇷Bucheon, Korea, Republic of
1222.14.5306 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1222.14.5303 Boehringer Ingelheim Investigational Site
🇰🇷Wonju, Korea, Republic of
1222.14.4501 Boehringer Ingelheim Investigational Site
🇸🇪Boden, Sweden
1222.14.4502 Boehringer Ingelheim Investigational Site
🇸🇪Lund, Sweden
1222.14.4303 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1222.14.4401 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1222.14.4902 Boehringer Ingelheim Investigational Site
🇿🇦Cape Town, South Africa
1222.14.4405 Boehringer Ingelheim Investigational Site
🇪🇸Mérida, Spain
1222.14.6202 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1222.14.5803 Boehringer Ingelheim Investigational Site
🇵🇭Iloilo City, Philippines
1222.14.4407 Boehringer Ingelheim Investigational Site
🇪🇸Terrassa (Barcelona), Spain
1222.14.4403 Boehringer Ingelheim Investigational Site
🇪🇸Palma de Mallorca, Spain
1222.14.4406 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1222.14.5305 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1222.14.4402 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1222.14.6201 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1222.14.6002 Boehringer Ingelheim Investigational Site
🇨🇿Kyjov, Czech Republic
1222.14.6001 Boehringer Ingelheim Investigational Site
🇨🇿Znojmo, Czech Republic
1222.14.5412 Boehringer Ingelheim Investigational Site
🇮🇳Coimbatore, India
1222.14.5405 Boehringer Ingelheim Investigational Site
🇮🇳Jaipur, India
1222.14.5404 Boehringer Ingelheim Investigational Site
🇮🇳Nagpur, India
1222.14.4802 Boehringer Ingelheim Investigational Site
🇳🇴Fredrikstad, Norway
1222.14.5902 Boehringer Ingelheim Investigational Site
🇹🇭Songkla, Thailand
1222.14.4011 Boehringer Ingelheim Investigational Site
🇨🇦Saskatoon, Saskatchewan, Canada
1222.14.4002 Boehringer Ingelheim Investigational Site
🇨🇦Kelowna, British Columbia, Canada
1222.14.6004 Boehringer Ingelheim Investigational Site
🇨🇿Brno, Czech Republic
1222.14.5407 Boehringer Ingelheim Investigational Site
🇮🇳Mysore, India
1222.14.5401 Boehringer Ingelheim Investigational Site
🇮🇳Pune, India
1222.14.5408 Boehringer Ingelheim Investigational Site
🇮🇳Noida, India
1222.14.5410 Boehringer Ingelheim Investigational Site
🇮🇳Vellore, India
1222.14.5701 Boehringer Ingelheim Investigational Site
🇲🇾Georgetown, Pulau Pinang, Malaysia
1222.14.5901 Boehringer Ingelheim Investigational Site
🇹🇭Khon Kaen, Thailand
1222.14.4702 Boehringer Ingelheim Investigational Site
🇫🇮Espoo, Finland
1222.14.5402 Boehringer Ingelheim Investigational Site
🇮🇳Indore, India
1222.14.4004 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1222.14.5409 Boehringer Ingelheim Investigational Site
🇮🇳Jaipur, India
1222.14.4701 Boehringer Ingelheim Investigational Site
🇫🇮HUS, Finland
1222.14.5703 Boehringer Ingelheim Investigational Site
🇲🇾Kuala Lumpur, Malaysia
1222.14.5702 Boehringer Ingelheim Investigational Site
🇲🇾Kuching, Sarawak, Malaysia
1222.14.5802 Boehringer Ingelheim Investigational Site
🇵🇭Iloilo City, Philippines
1222.14.4010 Boehringer Ingelheim Investigational Site
🇨🇦St. John's, Newfoundland and Labrador, Canada
1222.14.4801 Boehringer Ingelheim Investigational Site
🇳🇴SKI, Norway
1222.14.6103 Boehringer Ingelheim Investigational Site
🇷🇴Brasov, Romania
1222.14.6102 Boehringer Ingelheim Investigational Site
🇷🇴Constanta, Romania
1222.14.6101 Boehringer Ingelheim Investigational Site
🇷🇴Iasi, Romania
1222.14.5904 Boehringer Ingelheim Investigational Site
🇹🇭Bangkok, Thailand
1222.14.4603 Boehringer Ingelheim Investigational Site
🇩🇰Roskilde, Denmark
1222.14.4008 Boehringer Ingelheim Investigational Site
🇨🇦Grimsby, Ontario, Canada
1222.14.4012 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1222.14.4015 Boehringer Ingelheim Investigational Site
🇨🇦Sherbrooke, Quebec, Canada
1222.14.5103 Boehringer Ingelheim Investigational Site
🇧🇷Porto Alegre, Brazil
1222.14.5003 Boehringer Ingelheim Investigational Site
🇦🇷Mar del Plata, Argentina
1222.14.5105 Boehringer Ingelheim Investigational Site
🇧🇷Sao Paulo, Brazil
1222.14.5102 Boehringer Ingelheim Investigational Site
🇧🇷Recife, Brazil
1222.14.5104 Boehringer Ingelheim Investigational Site
🇧🇷Porto Alegre, Brazil
1222.14.4014 Boehringer Ingelheim Investigational Site
🇨🇦Mississauga, Ontario, Canada
1222.14.6003 Boehringer Ingelheim Investigational Site
🇨🇿Hradec Kralove, Czech Republic
1222.14.4006 Boehringer Ingelheim Investigational Site
🇨🇦Quebec, Canada
1222.14.4703 Boehringer Ingelheim Investigational Site
🇫🇮Lohja, Finland
1222.14.4601 Boehringer Ingelheim Investigational Site
🇩🇰Hillerød, Denmark
1222.14.4113 Boehringer Ingelheim Investigational Site
🇩🇪Minden, Germany
1222.14.5406 Boehringer Ingelheim Investigational Site
🇮🇳Hyderabad, India
1222.14.5403 Boehringer Ingelheim Investigational Site
🇮🇳Mangalore, India
1222.14.5801 Boehringer Ingelheim Investigational Site
🇵🇭Manila, Philippines
1222.14.4901 Boehringer Ingelheim Investigational Site
🇿🇦Cape Town, South Africa
1222.14.4114 Boehringer Ingelheim Investigational Site
🇩🇪Lübeck, Germany
1222.14.5302 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1222.14.6203 Boehringer Ingelheim Investigational Site
🇷🇺Petrozavodsk, Russian Federation
1222.14.4105 Boehringer Ingelheim Investigational Site
🇩🇪Wiesloch, Germany
1222.14.4009 Boehringer Ingelheim Investigational Site
🇨🇦Moncton, New Brunswick, Canada
1222.14.5501 Boehringer Ingelheim Investigational Site
🇭🇰Hong Kong, Hong Kong