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 | 813 |
| 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 |
|---|---|---|---|
| Belgium | 1237.25.32001 Boehringer Ingelheim Investigational Site | Brussel | |
| Belgium | 1237.25.32004 Boehringer Ingelheim Investigational Site | Brussels | |
| Belgium | 1237.25.32005 Boehringer Ingelheim Investigational Site | Eupen | |
| Belgium | 1237.25.32003 Boehringer Ingelheim Investigational Site | Lebbeke | |
| Belgium | 1237.25.32002 Boehringer Ingelheim Investigational Site | Turnhout | |
| Canada | 1237.25.11505 Boehringer Ingelheim Investigational Site | Burlington | Ontario |
| Canada | 1237.25.11508 Boehringer Ingelheim Investigational Site | Calgary | Alberta |
| Canada | 1237.25.11504 Boehringer Ingelheim Investigational Site | Edmonton | Alberta |
| Canada | 1237.25.11507 Boehringer Ingelheim Investigational Site | Grimsby | Ontario |
| Canada | 1237.25.11510 Boehringer Ingelheim Investigational Site | Ottawa | Ontario |
| Canada | 1237.25.11502 Boehringer Ingelheim Investigational Site | Quebec | |
| Canada | 1237.25.11506 Boehringer Ingelheim Investigational Site | Quebec | |
| Canada | 1237.25.11509 Boehringer Ingelheim Investigational Site | Sherbrooke, | Quebec |
| Canada | 1237.25.11501 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia |
| Czech Republic | 1237.25.42003 Boehringer Ingelheim Investigational Site | Jindrichuv Hradec | |
| Czech Republic | 1237.25.42005 Boehringer Ingelheim Investigational Site | Karlovy Vary-Drahovice | |
| Czech Republic | 1237.25.42002 Boehringer Ingelheim Investigational Site | Neratovice | |
| Czech Republic | 1237.25.42001 Boehringer Ingelheim Investigational Site | Prague | |
| Czech Republic | 1237.25.42004 Boehringer Ingelheim Investigational Site | Rokycany | |
| Denmark | 1237.25.45003 Boehringer Ingelheim Investigational Site | Ålborg | |
| Denmark | 1237.25.45002 Boehringer Ingelheim Investigational Site | Hellerup | |
| Denmark | 1237.25.45001 Boehringer Ingelheim Investigational Site | Odense | |
| Denmark | 1237.25.45004 Boehringer Ingelheim Investigational Site | Silkeborg | |
| Finland | 1237.25.35802 Boehringer Ingelheim Investigational Site | Pori | |
| Finland | 1237.25.35801 Boehringer Ingelheim Investigational Site | Turku | |
| Finland | 1237.25.35803 Boehringer Ingelheim Investigational Site | Turku | |
| Germany | 1237.25.49504 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | 1237.25.49508 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | 1237.25.49510 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | 1237.25.49501 Boehringer Ingelheim Investigational Site | Großhansdorf | |
| Germany | 1237.25.49505 Boehringer Ingelheim Investigational Site | Halle/Saale | |
| Germany | 1237.25.49506 Boehringer Ingelheim Investigational Site | Hamburg | |
| Germany | 1237.25.49515 Boehringer Ingelheim Investigational Site | Hamburg | |
| Germany | 1237.25.49509 Boehringer Ingelheim Investigational Site | Hannover | |
| Germany | 1237.25.49514 Boehringer Ingelheim Investigational Site | Koblenz | |
| Germany | 1237.25.49507 Boehringer Ingelheim Investigational Site | Mainz | |
| Germany | 1237.25.49502 Boehringer Ingelheim Investigational Site | Neu-Isenburg | |
| Germany | 1237.25.49516 Boehringer Ingelheim Investigational Site | Oschersleben | |
| Germany | 1237.25.49511 Boehringer Ingelheim Investigational Site | Rodgau | |
| Germany | 1237.25.49503 Boehringer Ingelheim Investigational Site | Rosenheim | |
| Germany | 1237.25.49513 Boehringer Ingelheim Investigational Site | Teuchern | |
| South Africa | 1237.25.27506 Boehringer Ingelheim Investigational Site | Bloemfontein | |
| South Africa | 1237.25.27501 Boehringer Ingelheim Investigational Site | Cape Town | |
| South Africa | 1237.25.27504 Boehringer Ingelheim Investigational Site | Morningside, Sandton | |
| South Africa | 1237.25.27502 Boehringer Ingelheim Investigational Site | Parow | |
| South Africa | 1237.25.27503 Boehringer Ingelheim Investigational Site | Pretoria | |
| South Africa | 1237.25.27505 Boehringer Ingelheim Investigational Site | Umkomaas | |
| Spain | 1237.25.34003 Boehringer Ingelheim Investigational Site | Alicante | |
| Spain | 1237.25.34007 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1237.25.34001 Boehringer Ingelheim Investigational Site | Mérida | |
| Spain | 1237.25.34002 Boehringer Ingelheim Investigational Site | Pozuelo de Alarcón | |
| Spain | 1237.25.34004 Boehringer Ingelheim Investigational Site | Vic | |
| United Kingdom | 1237.25.44002 Boehringer Ingelheim Investigational Site | Bradford | |
| United Kingdom | 1237.25.44001 Boehringer Ingelheim Investigational Site | Chertsey | |
| United Kingdom | 1237.25.44004 Boehringer Ingelheim Investigational Site | Chester | |
| United Kingdom | 1237.25.44005 Boehringer Ingelheim Investigational Site | Chippenham | |
| United Kingdom | 1237.25.44003 Boehringer Ingelheim Investigational Site | Wolverhampton | |
| United States | 1237.25.10516 Boehringer Ingelheim Investigational Site | Ann Arbor | Michigan |
| United States | 1237.25.10513 Boehringer Ingelheim Investigational Site | Charleston | South Carolina |
| United States | 1237.25.10519 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina |
| United States | 1237.25.10503 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio |
| United States | 1237.25.10507 Boehringer Ingelheim Investigational Site | Clearwater | Florida |
| United States | 1237.25.10505 Boehringer Ingelheim Investigational Site | Coeur d'Alene | Idaho |
| United States | 1237.25.10518 Boehringer Ingelheim Investigational Site | Columbia | Ohio |
| United States | 1237.25.10502 Boehringer Ingelheim Investigational Site | Columbus | Ohio |
| United States | 1237.25.10511 Boehringer Ingelheim Investigational Site | Dublin | Ohio |
| United States | 1237.25.10515 Boehringer Ingelheim Investigational Site | Easley | South Carolina |
| United States | 1237.25.10506 Boehringer Ingelheim Investigational Site | Greenville | South Carolina |
| United States | 1237.25.10520 Boehringer Ingelheim Investigational Site | Killeen | Texas |
| United States | 1237.25.10509 Boehringer Ingelheim Investigational Site | Livonia | Michigan |
| United States | 1237.25.10517 Boehringer Ingelheim Investigational Site | Panama City | Florida |
| United States | 1237.25.10514 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania |
| United States | 1237.25.10510 Boehringer Ingelheim Investigational Site | Richmond | Virginia |
| United States | 1237.25.10501 Boehringer Ingelheim Investigational Site | Rock Hill | South Carolina |
| United States | 1237.25.10508 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina |
| United States | 1237.25.10521 Boehringer Ingelheim Investigational Site | Spokane | Washington |
| United States | 1237.25.10504 Boehringer Ingelheim Investigational Site | Wheat Ridge | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Belgium, Canada, Czech Republic, Denmark, Finland, Germany, South Africa, Spain, United Kingdom,
| 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 | This endpoint was evaluated based on the data from this individual trial and also based on the data from the combined dataset from this trial and the replicate study NCT02006732. The results for the combined dataset are included in the disclosure for NCT02006732 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 | This endpoint was evaluated based on the data from this individual trial and also based on the data from the combined dataset from this trial and the replicate study NCT02006732. The results for the combined dataset are included in the disclosure for NCT02006732 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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