Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)
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| ClinicalTrials.gov Identifier: NCT01964352 |
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Recruitment Status :
Completed
First Posted : October 17, 2013
Results First Posted : November 25, 2015
Last Update Posted : November 25, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Disease, Chronic Obstructive | Drug: tiotropium Drug: placebo Drug: olodaterol | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 813 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| 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) |
| Study Start Date : | November 2013 |
| Actual Primary Completion Date : | October 2014 |
| Actual Study Completion Date : | November 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: tiotropium + olodaterol low dose
Once daily 2 puffs solution for inhalation Respimat
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Drug: tiotropium
fixed dose combination Drug: olodaterol fixed dose combination |
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Experimental: tiotropium + olodaterol high dose
Once daily 2 puffs solution for inhalation Respimat
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Drug: tiotropium
fixed dose combination Drug: olodaterol fixed dose combination |
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Active Comparator: tiotropium
Once daily 2 puffs solution for inhalation Respimat
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Drug: tiotropium |
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Placebo Comparator: placebo
Once daily 2 puffs solution for inhalation Respimat
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Drug: placebo |
- FEV1 AUC0-3h Response [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
- Trough Forced Vital Capacity (FVC) Response (Change From Baseline) [ Time Frame: 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.
- TDI Focal Score [ Time Frame: 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.
- FVC AUC0-3h Response (Change From Baseline) [ Time Frame: 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.
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964352
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| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01964352 History of Changes |
| Other Study ID Numbers: |
1237.25 2013-002243-29 ( EudraCT Number: EudraCT ) |
| First Posted: | October 17, 2013 Key Record Dates |
| Results First Posted: | November 25, 2015 |
| Last Update Posted: | November 25, 2015 |
| Last Verified: | October 2015 |
Additional relevant MeSH terms:
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Chronic Disease Respiratory Tract Diseases Disease Attributes Pathologic Processes Tiotropium Bromide Olodaterol Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Parasympatholytics Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-1 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents |