Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomised, Double-blind, Placebo- and Active-controlled Parallel Group Study to Assess the Efficacy of 12 Weeks of Once Daily Treatment of Two Doses of Orally Inhaled Tiotropium+ Olodaterol Fixed Dose Combination (Delivered by the Respimat Inhaler) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.
| Status | Completed |
| Enrollment | 809 |
| Est. completion date | November 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Inclusion criteria: - Diagnosis chronic obstructive pulmonary disease - Relatively stable airway obstruction with post FEV1 >=30 and < 80% predicted normal and post FEV1/ FVC < 70% - Male or female patients, 40 years of age or more - Smoking history more than 10 pack years Exclusion criteria: - Significant diseases other than COPD - History of asthma - COPD exacerbation in previous 3 months - Completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program. - Pregnant or nursing women - Patients unable to comply with pulmonary medication restrictions |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | 1237.26.61004 Boehringer Ingelheim Investigational Site | Concord | New South Wales |
| Australia | 1237.26.61002 Boehringer Ingelheim Investigational Site | Daw Park | South Australia |
| Australia | 1237.26.61005 Boehringer Ingelheim Investigational Site | Murdoch | Western Australia |
| Australia | 1237.26.61001 Boehringer Ingelheim Investigational Site | Nedlands | Western Australia |
| Australia | 1237.26.61003 Boehringer Ingelheim Investigational Site | Toorak Gardens | South Australia |
| Australia | 1237.26.61007 Boehringer Ingelheim Investigational Site | Woodville | South Australia |
| Austria | 1237.26.43004 Boehringer Ingelheim Investigational Site | Feldbach | |
| Austria | 1237.26.43002 Boehringer Ingelheim Investigational Site | Grieskirchen | |
| Austria | 1237.26.43003 Boehringer Ingelheim Investigational Site | Linz | |
| Austria | 1237.26.43006 Boehringer Ingelheim Investigational Site | Linz | |
| Austria | 1237.26.43001 Boehringer Ingelheim Investigational Site | Thalheim bei Wels | |
| Canada | 1237.26.11609 Boehringer Ingelheim Investigational Site | Courtice | Ontario |
| Canada | 1237.26.11611 Boehringer Ingelheim Investigational Site | Mirabel | Quebec |
| Canada | 1237.26.11605 Boehringer Ingelheim Investigational Site | Moncton | New Brunswick |
| Canada | 1237.26.11602 Boehringer Ingelheim Investigational Site | Point Claire | Quebec |
| Canada | 1237.26.11608 Boehringer Ingelheim Investigational Site | Sarnia | Ontario |
| Canada | 1237.26.11603 Boehringer Ingelheim Investigational Site | Sherbrooke | Quebec |
| Canada | 1237.26.11606 Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Canada | 1237.26.11607 Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Canada | 1237.26.11601 Boehringer Ingelheim Investigational Site | Windsor | Ontario |
| Germany | 1237.26.49610 Boehringer Ingelheim Investigational Site | Bamberg | |
| Germany | 1237.26.49611 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | 1237.26.49616 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | 1237.26.49609 Boehringer Ingelheim Investigational Site | Bochum | |
| Germany | 1237.26.49607 Boehringer Ingelheim Investigational Site | Dresden | |
| Germany | 1237.26.49612 Boehringer Ingelheim Investigational Site | Frankfurt | |
| Germany | 1237.26.49615 Boehringer Ingelheim Investigational Site | Halberstadt | |
| Germany | 1237.26.49606 Boehringer Ingelheim Investigational Site | Hamburg | |
| Germany | 1237.26.49608 Boehringer Ingelheim Investigational Site | Hannover | |
| Germany | 1237.26.49603 Boehringer Ingelheim Investigational Site | Hettstedt | |
| Germany | 1237.26.49604 Boehringer Ingelheim Investigational Site | Leipzig | |
| Germany | 1237.26.49605 Boehringer Ingelheim Investigational Site | Leipzig | |
| Germany | 1237.26.49601 Boehringer Ingelheim Investigational Site | Lübeck | |
| Germany | 1237.26.49602 Boehringer Ingelheim Investigational Site | Rüdersdorf | |
| Germany | 1237.26.49614 Boehringer Ingelheim Investigational Site | Schwerin | |
| Germany | 1237.26.49613 Boehringer Ingelheim Investigational Site | Wiesloch | |
| Greece | 1237.26.30005 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1237.26.30002 Boehringer Ingelheim Investigational Site | Heraklion | |
| Greece | 1237.26.30001 Boehringer Ingelheim Investigational Site | Nafplio | |
| Greece | 1237.26.30004 Boehringer Ingelheim Investigational Site | Serres | |
| Greece | 1237.26.30003 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| New Zealand | 1237.26.64001 Boehringer Ingelheim Investigational Site | Greenlane East Auckland NZ | |
| Norway | 1237.26.47003 Boehringer Ingelheim Investigational Site | Hamar | |
| Norway | 1237.26.47001 Boehringer Ingelheim Investigational Site | Hønefoss | |
| Norway | 1237.26.47002 Boehringer Ingelheim Investigational Site | Kløfta | |
| Norway | 1237.26.47004 Boehringer Ingelheim Investigational Site | Lierskogen | |
| Slovakia | 1237.26.42103 Boehringer Ingelheim Investigational Site | Bardejov | |
| Slovakia | 1237.26.42104 Boehringer Ingelheim Investigational Site | Humenne | |
| Slovakia | 1237.26.42102 Boehringer Ingelheim Investigational Site | Spisska Nova Ves | |
| Slovakia | 1237.26.42101 Boehringer Ingelheim Investigational Site | Vysne Hagy | |
| South Africa | 1237.26.27601 Boehringer Ingelheim Investigational Site | Cape Town | |
| South Africa | 1237.26.27602 Boehringer Ingelheim Investigational Site | Cape Town | |
| South Africa | 1237.26.27604 Boehringer Ingelheim Investigational Site | Cape Town | |
| South Africa | 1237.26.27605 Boehringer Ingelheim Investigational Site | Durban | |
| Sweden | 1237.26.46004 Boehringer Ingelheim Investigational Site | Höllviken | |
| Sweden | 1237.26.46001 Boehringer Ingelheim Investigational Site | Lund | |
| Sweden | 1237.26.46002 Boehringer Ingelheim Investigational Site | Stockholm | |
| Sweden | 1237.26.46003 Boehringer Ingelheim Investigational Site | Uddevalla | |
| United States | 1237.26.10609 Boehringer Ingelheim Investigational Site | Boerne | Texas |
| United States | 1237.26.10619 Boehringer Ingelheim Investigational Site | Clearwater | Florida |
| United States | 1237.26.10603 Boehringer Ingelheim Investigational Site | Columbus | Ohio |
| United States | 1237.26.10621 Boehringer Ingelheim Investigational Site | Dayton | Ohio |
| United States | 1237.26.10616 Boehringer Ingelheim Investigational Site | Duluth | Georgia |
| United States | 1237.26.10610 Boehringer Ingelheim Investigational Site | East Providence | Rhode Island |
| United States | 1237.26.10607 Boehringer Ingelheim Investigational Site | Gaffney | South Carolina |
| United States | 1237.26.10615 Boehringer Ingelheim Investigational Site | Greensboro | North Carolina |
| United States | 1237.26.10617 Boehringer Ingelheim Investigational Site | Greenville | South Carolina |
| United States | 1237.26.10620 Boehringer Ingelheim Investigational Site | Jasper | Alabama |
| United States | 1237.26.10606 Boehringer Ingelheim Investigational Site | Medford | Oregon |
| United States | 1237.26.10601 Boehringer Ingelheim Investigational Site | Morgantown | West Virginia |
| United States | 1237.26.10605 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma |
| United States | 1237.26.10602 Boehringer Ingelheim Investigational Site | San Antonio | Texas |
| United States | 1237.26.10608 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina |
| United States | 1237.26.10613 Boehringer Ingelheim Investigational Site | St. Louis | Missouri |
| United States | 1237.26.10618 Boehringer Ingelheim Investigational Site | Stamford | Connecticut |
| United States | 1237.26.10614 Boehringer Ingelheim Investigational Site | Tampa | Florida |
| United States | 1237.26.10612 Boehringer Ingelheim Investigational Site | Toledo | Ohio |
| United States | 1237.26.10604 Boehringer Ingelheim Investigational Site | Union | South Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Australia, Austria, Canada, Germany, Greece, New Zealand, Norway, Slovakia, South Africa, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | FEV1 AUC0-3h Response | Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom. | baseline and 12 weeks | No |
| Primary | Trough FEV1 Response (Change From Baseline) | Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FEV1 measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FEV1 response was defines as trough FEV1 minus baseline FEV1. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom. | baseline and 12 weeks | No |
| Primary | St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study | The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life). The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom. |
12 weeks treatment | No |
| Primary | St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352 | This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life). The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom. |
12 weeks treatment | No |
| Secondary | Trough Forced Vital Capacity (FVC) Response (Change From Baseline) | Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FVC measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FVC response was defined as trough FVC minus baseline FVC. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom. | baseline and 12 weeks | No |
| Secondary | TDI Focal Score Based on Data From This Individual Study | Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9). The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom. |
12 weeks | No |
| Secondary | TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352 | This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9). The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom. |
12 weeks | No |
| Secondary | FVC AUC0-3h Response (Change From Baseline) | The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom. | baseline and 12 weeks | No |
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