Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: tiotropium; Drug: placebo; Drug: olodaterol

• Registration Number: NCT01964352
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-14
• Study First Submitted QC: 2013-10-14
• Study First Posted: 2013-10-17
• Study Start: 2013-11
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Status Verified: 2015-10
• Results First Submitted: 2015-10-23
• Results First Submitted QC: 2015-10-23
• Last Update Submitted: 2015-10-23
• Results First Posted: 2015-11-25
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 813

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tiotropium + olodaterol low dose	tiotropium	Once daily 2 puffs solution for inhalation Respimat
placebo	placebo	Once daily 2 puffs solution for inhalation Respimat
tiotropium	tiotropium	Once daily 2 puffs solution for inhalation Respimat
tiotropium + olodaterol low dose	olodaterol	Once daily 2 puffs solution for inhalation Respimat
tiotropium + olodaterol high dose	tiotropium	Once daily 2 puffs solution for inhalation Respimat
tiotropium + olodaterol high dose	olodaterol	Once daily 2 puffs solution for inhalation Respimat

Primary Outcome Measures

Name	Time	Method
FEV1 AUC0-3h Response	baseline and 12 weeks	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.
Trough FEV1 Response (Change From Baseline)	baseline and 12 weeks	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.
St. George's Respiratory Questionnaire (SGRQ) Total Score	12 weeks treatment	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.

Secondary Outcome Measures

Name	Time	Method
FVC AUC0-3h Response (Change From Baseline)	baseline and 12 weeks	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.
TDI Focal Score	12 weeks	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.
Trough Forced Vital Capacity (FVC) Response (Change From Baseline)	baseline and 12 weeks	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.

Trial Locations

Locations (77)

1237.25.10504 Boehringer Ingelheim Investigational Site; 🇺🇸 Wheat Ridge, Colorado, United States

1237.25.10507 Boehringer Ingelheim Investigational Site; 🇺🇸 Clearwater, Florida, United States

1237.25.10517 Boehringer Ingelheim Investigational Site; 🇺🇸 Panama City, Florida, United States

1237.25.10505 Boehringer Ingelheim Investigational Site; 🇺🇸 Coeur d'Alene, Idaho, United States

1237.25.10516 Boehringer Ingelheim Investigational Site; 🇺🇸 Ann Arbor, Michigan, United States

1237.25.10509 Boehringer Ingelheim Investigational Site; 🇺🇸 Livonia, Michigan, 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

1237.25.10518 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbia, Ohio, United States

1237.25.10502 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbus, Ohio, United States

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