Clinical Trials List
2015-05-01 - 2017-03-25
Phase III
Terminated13
ICD-10J44.9
Chronic obstructive pulmonary disease, unspecified
ICD-10J44
Other chronic obstructive pulmonary disease
ICD-10J44.1
Chronic obstructive pulmonary disease with (acute) exacerbation
A randomized, double-blind, active drug-controlled, parallel grouping trial, in patients with severe to very severe chronic obstructive pulmonary disease (COPD), using tiotropium as a benchmark to evaluate oral inhaled tiotropium + olodaterol fixed-dose combination once a day The effect of 52-week treatment on the acute onset of COPD. [DYNAGITO]
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Trial Applicant
Boehringer Ingelheim
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Sponsor
BI
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- jong rung Tsai Division of Thoracic Medicine
- Chau-Chyun Sheu Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 廖偉志 Division of Thoracic Medicine
- Yu-Chao Lin Division of Thoracic Medicine
- Chih-Ching Yen Division of Thoracic Medicine
- 梁信杰 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
1 Completed
Audit
None
Co-Principal Investigator
- Chih-Hsin Lee Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 黃國棟 Division of Thoracic Medicine
- 劉世豐 Division of Thoracic Medicine
- Chia-Cheng Tseng Division of Thoracic Medicine
- 方文豐 Division of Thoracic Medicine
- 蘇茂昌 Division of Thoracic Medicine
- 林孟志 Division of Thoracic Medicine
- 吳沼漧 Division of Thoracic Medicine
- CHIN-CHOU WANG Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Tzu-Tao Chen Division of Thoracic Medicine
- Wen-Te Liu Division of Thoracic Medicine
- Po-Hao Feng Division of Thoracic Medicine
- Kuan-Yuan Chen Division of Thoracic Medicine
- Chih-Cheng Chang Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Completed
Audit
CRO
Co-Principal Investigator
- Ning-Hung Chen Division of Thoracic Medicine
- Kuo-Chin Kao Division of Thoracic Medicine
- 張志豪 Division of Thoracic Medicine
- Chih-Hung Chen Division of Thoracic Medicine
- Chih-Hung Chen Division of Thoracic Medicine
- Chih-Liang Wang Division of Thoracic Medicine
- 林倡葦 Division of Thoracic Medicine
- Chien-Ying Liu Division of Thoracic Medicine
- Shih-Wei Lin Division of Thoracic Medicine
- 黃世豪 Division of Thoracic Medicine
- Chung-Chi Huang Division of Thoracic Medicine
- 胡漢忠 Division of Thoracic Medicine
- 李忠恕 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Co-Principal Investigator
Audit
CRO
Co-Principal Investigator
- 吳惠東 Division of Thoracic Medicine
- HAO-CHIEN WANG Division of Thoracic Medicine
- 許嘉林 Division of Thoracic Medicine
- 鄭之勛 Division of Thoracic Medicine
- Ping-Hung Kuo Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
- Annual incidence of moderate to severe acute episodes of COPD during treatment (occurs within 1 day after the last dose)
Key secondary endpoint
- Time for the first acute episode of moderate to severe COPD during treatment (occurs within 1 day after the last dose)
Secondary endpoint
- Annual incidence of acute attacks that resulted in hospitalization during treatment (occurred within 1 day after the last dose)
- Time of the first acute attack that led to hospitalization during treatment (occurs within 1 day after the last dose)
- Time of death from all causes (occurred within 1 day after the last dose)
Other end points
- Time to the first occurrence of an acute episode of moderate to severe COPD that requires antibiotic treatment (occurs within 1 day after the last dose)
- Time to the first occurrence of an acute episode of moderate to severe COPD that requires systemic corticosteroid therapy (occurs within 1 day after the last dose)
- Time to the first occurrence of an acute episode of moderate to severe COPD that requires systemic corticosteroids and antibiotics (occurs within 1 day after the last dose)
- Annual incidence of acute episodes of COPD requiring systemic corticosteroid therapy (occurred within 1 day after the last dose)
- Annual incidence of acute episodes of COPD requiring antibiotic treatment (occurred within 1 day after the last dose)
- Annual incidence of acute episodes of COPD requiring systemic corticosteroids and antibiotics (occurs within 1 day after the last dose)
- Annual incidence of all acute episodes of COPD (occurred within 1 day after the last dose)
- Chronic obstructive pulmonary disease assessment test during office visit (CAT) score
- Medical Resource Utilization (HCRU) data for medical economic analysis
Inclution Criteria
1. ≥ 40-year-old outpatients with FEV1 <60% of the predicted value after bronchodilator use and FEV1/FVC <70% after bronchodilator use (male and female)
2. At least one acute episode of moderate to severe COPD has been recorded in the past 12 months
3. Current or past history of smoking> 10 pack years
Exclusion Criteria
The Estimated Number of Participants
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Taiwan
80 participants
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Global
7800 participants
