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Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00793624
First received: November 18, 2008
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Olodaterol (BI 1744)
Drug: Formoterol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 µg [2 Actuations of 2.5 ug] and 10 ug [2 Actuations of 5 ug]) Delivered by the Respimat® Inhaler, and 48 Weeks of Twice Daily Foradil® (12 µg) Delivered by the Aerolizer® Inhaler, in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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 24 Weeks for Combined Analysis [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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).

  • Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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).

  • Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
    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).

  • Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 6 Weeks [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 48 Weeks [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 2 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 6 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 12 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 32 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 2 Weeks [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 12 Weeks [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 6 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 12 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 48 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 6 Weeks [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 12 Weeks [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 24 Weeks [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Mean number of puffs of rescue medication used per day (daytime/nighttime/total)

  • Patient's Global Rating (PGR) at 6 Weeks [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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 12 Weeks [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 24 Weeks [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    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 6 Weeks [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    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 12 Weeks [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 18 Weeks [ Time Frame: Baseline, Week 18 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 32 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 40 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
    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).

  • Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation [ Time Frame: Baseline to end of study at 48 weeks. ] [ Designated as safety issue: No ]
    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.

  • Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization [ Time Frame: Baseline to end of study at 48 weeks. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to end of study at 48 weeks. ] [ Designated as safety issue: No ]
    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.

  • Number of COPD Exacerbations [ Time Frame: Baseline to end of study at week 48 visit ] [ Designated as safety issue: No ]
    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 COPD Exacerbations Requiring Hospitalization [ Time Frame: Baseline to end of study at week 48 visit ] [ Designated as safety issue: No ]
    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.

  • Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations [ Time Frame: Baseline to end of study at 48 weeks. ] [ Designated as safety issue: No ]
    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.

  • Absolute Plasma Concentrations [ Time Frame: within 2 hours before first drug administration and 10 minutes post-dose at week 6, 12 and 18 ] [ Designated as safety issue: No ]
    Absolute plasma concentrations of Olodaterol. Values presented are across visits and summarised into geometric means.

  • Changes in Safety Parameters Related to Treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Occurence of cardiac disorders and investigations related to treatment.


Enrollment: 906
Study Start Date: February 2009
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olodaterol (BI 1744) Low
Low dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744)
Comparison of low and high doses on efficacy and safety in COPD patients
Experimental: Olodaterol (BI 1744) High
High dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744)
Comparison of low and high doses on efficacy and safety in COPD patients
Active Comparator: Formoterol 12mcg
12mcg inhaled twice daily from the Aerolizer inhaler
Drug: Formoterol
Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients
Placebo Comparator: Placebo
Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler and/or Formoterol placebo inhaled twice daily from the Aerolizer inhaler
Drug: Placebo
Placebo for comparison with Olodaterol (BI 1744) on safety and efficacy in COPD patients
Drug: Placebo
Placebo for comparison Formoterolon safety and efficacy in COPD patients

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:post-bronchodilator FEV1<80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC <70% at Visit 1
  2. Male or female patients, 40 years of age or older
  3. Patients must be current or ex-smokers with a smoking history of more than 10 pack years:

Exclusion criteria:

  1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN
  2. Patients with a history of asthma and/or total blood eosinophil count greater than 600/mm3
  3. Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute)
  4. Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse
  5. Patients who have undergone thoracotomy with pulmonary resection
  6. Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
  7. Patients who regularly use daytime oxygen therapy for more than one hour per day.
  8. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
  9. Pregnant or nursing women
  10. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793624

  Hide Study Locations
Locations
Argentina
1222.13.2401 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1222.13.2403 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1222.13.2402 Boehringer Ingelheim Investigational Site
Mar del Plata, Argentina
1222.13.2404 Boehringer Ingelheim Investigational Site
Monte Grande, Argentina
Brazil
1222.13.2502 Boehringer Ingelheim Investigational Site
Juiz de Fora, Brazil
1222.13.2503 Boehringer Ingelheim Investigational Site
Rio de Janeiro, Brazil
1222.13.2505 Boehringer Ingelheim Investigational Site
Rio de Janeiro, Brazil
1222.13.2501 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
1222.13.2504 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
Canada, Alberta
1222.13.1408 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
Canada, British Columbia
1222.13.1407 Boehringer Ingelheim Investigational Site
Chilliwack, British Columbia, Canada
Canada, Ontario
1222.13.1403 Boehringer Ingelheim Investigational Site
Downsview, Ontario, Canada
1222.13.1412 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1222.13.1401 Boehringer Ingelheim Investigational Site
Niagara Falls, Ontario, Canada
1222.13.1410 Boehringer Ingelheim Investigational Site
Sarnia, Ontario, Canada
1222.13.1413 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1222.13.1404 Boehringer Ingelheim Investigational Site
La Malbaie, Quebec, Canada
1222.13.1411 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1222.13.1406 Boehringer Ingelheim Investigational Site
Point Claire, Quebec, Canada
Canada, Saskatchewan
1222.13.1402 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
Croatia
1222.13.3502 Boehringer Ingelheim Investigational Site
Dubrovnik, Croatia
1222.13.3503 Boehringer Ingelheim Investigational Site
Rijeka, Croatia
1222.13.3504 Boehringer Ingelheim Investigational Site
Split, Croatia
1222.13.3501 Boehringer Ingelheim Investigational Site
Zagreb, Croatia
Czech Republic
1222.13.3401 Boehringer Ingelheim Investigational Site
Beroun, Czech Republic
1222.13.3403 Boehringer Ingelheim Investigational Site
Cesky Tesin, Czech Republic
1222.13.3402 Boehringer Ingelheim Investigational Site
Tabor, Czech Republic
Denmark
1222.13.2003 Boehringer Ingelheim Investigational Site
Aalborg, Denmark
1222.13.2002 Boehringer Ingelheim Investigational Site
Hvidovre, Denmark
1222.13.2001 Boehringer Ingelheim Investigational Site
Silkeborg, Denmark
Finland
1222.13.2103 Boehringer Ingelheim Investigational Site
Lahti, Finland
1222.13.2101 Boehringer Ingelheim Investigational Site
Tampere, Finland
1222.13.2102 Boehringer Ingelheim Investigational Site
Turku, Finland
Germany
1222.13.1506 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.13.1503 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.13.1502 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.13.1511 Boehringer Ingelheim Investigational Site
Dortmund, Germany
1222.13.1514 Boehringer Ingelheim Investigational Site
Essen, Germany
1222.13.1509 Boehringer Ingelheim Investigational Site
Großhansdorf, Germany
1222.13.1510 Boehringer Ingelheim Investigational Site
Hannover, Germany
1222.13.1508 Boehringer Ingelheim Investigational Site
Hannover, Germany
1222.13.1512 Boehringer Ingelheim Investigational Site
Kiel, Germany
1222.13.1501 Boehringer Ingelheim Investigational Site
Köln, Germany
1222.13.1505 Boehringer Ingelheim Investigational Site
Reinfeld, Germany
1222.13.1507 Boehringer Ingelheim Investigational Site
Schwerin, Germany
Hong Kong
1222.13.2901 Boehringer Ingelheim Investigational Site
Kowloon, Hong Kong
India
1222.13.2804 Boehringer Ingelheim Investigational Site
Bangalore, India
1222.13.2803 Boehringer Ingelheim Investigational Site
Chennai, India
1222.13.2806 Boehringer Ingelheim Investigational Site
Coimbatore-, India
1222.13.2810 Boehringer Ingelheim Investigational Site
Hyderabad, India
1222.13.2801 Boehringer Ingelheim Investigational Site
Indore, India
1222.13.2807 Boehringer Ingelheim Investigational Site
Indore, India
1222.13.2805 Boehringer Ingelheim Investigational Site
Jaipur, India
1222.13.2802 Boehringer Ingelheim Investigational Site
Ludhiana, Punjab, India
1222.13.2812 Boehringer Ingelheim Investigational Site
Mumbai, India
1222.13.2809 Boehringer Ingelheim Investigational Site
Mumbai, India
1222.13.2811 Boehringer Ingelheim Investigational Site
Pune, India
Italy
1222.13.1704 Boehringer Ingelheim Investigational Site
Catania, Italy
1222.13.1702 Boehringer Ingelheim Investigational Site
Genova, Italy
1222.13.1701 Boehringer Ingelheim Investigational Site
Pisa, Italy
1222.13.1705 Boehringer Ingelheim Investigational Site
Siena, Italy
1222.13.1703 Boehringer Ingelheim Investigational Site
Trieste, Italy
Korea, Republic of
1222.13.2701 Boehringer Ingelheim Investigational Site
Gwangju, Korea, Republic of
1222.13.2702 Boehringer Ingelheim Investigational Site
Incheon, Korea, Republic of
1222.13.2703 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1222.13.2705 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1222.13.2706 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1222.13.2704 Boehringer Ingelheim Investigational Site
Suwon, Korea, Republic of
Malaysia
1222.13.3103 Boehringer Ingelheim Investigational Site
Batu Caves, Malaysia
1222.13.3101 Boehringer Ingelheim Investigational Site
Kota Kinabalu, Malaysia
1222.13.3102 Boehringer Ingelheim Investigational Site
Kuala Lumpur, Malaysia
1222.13.3104 Boehringer Ingelheim Investigational Site
Kuantan, Malaysia
Norway
1222.13.2201 Boehringer Ingelheim Investigational Site
Bergen, Norway
1222.13.2202 Boehringer Ingelheim Investigational Site
Oslo, Norway
Philippines
1222.13.3203 Boehringer Ingelheim Investigational Site
Cebu, Philippines
1222.13.3201 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
1222.13.3202 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
South Africa
1222.13.2302 Boehringer Ingelheim Investigational Site
Durban, South Africa
1222.13.2301 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
Spain
1222.13.1803 Boehringer Ingelheim Investigational Site
Aranjuez, Spain
1222.13.1806 Boehringer Ingelheim Investigational Site
Elda, Spain
1222.13.1802 Boehringer Ingelheim Investigational Site
Els Hostalets de Balenyà, Spain
1222.13.1804 Boehringer Ingelheim Investigational Site
Pozuelo de Alarcón, Spain
1222.13.1805 Boehringer Ingelheim Investigational Site
Valladolid, Spain
1222.13.1801 Boehringer Ingelheim Investigational Site
Vic (Barcelona), Spain
Sweden
1222.13.1901 Boehringer Ingelheim Investigational Site
Boden, Sweden
1222.13.1902 Boehringer Ingelheim Investigational Site
Sundsvall, Sweden
Thailand
1222.13.3302 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
1222.13.3303 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
1222.13.3301 Boehringer Ingelheim Investigational Site
Chiang Mai, Thailand
Ukraine
1222.13.3602 Boehringer Ingelheim Investigational Site
Ivano-Frankivsk, Ukraine
1222.13.3601 Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
1222.13.3603 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00793624     History of Changes
Other Study ID Numbers: 1222.13, 2008-001933-84
Study First Received: November 18, 2008
Results First Received: March 28, 2014
Last Updated: June 17, 2014
Health Authority: Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica)
Brazil: National Health Surveillance Agency
Canada: Therapeutic Products Directorate
Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Denmark: The Danish Medicines Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
India: Drugs Controller General of India
Italy: Comitato Etico per la sperim. clinica dei medicinali dell'A.O. Universitaria Pisana di Pisa
Korea, Republic of: Korea Food and Drug Administration
Malaysia: Ministry of Health
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Philippines: Department of Health
South Africa: Medicines Control Council
Spain: Agencia Espanola del Medicamento y Productos Sanitarios
Sweden: Medical Products Agency Regional Ethics Committee of Umeå
Thailand: Ministry of Public Health
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Formoterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014