Japan Long-term Safety for Tiotropium Plus Olodaterol
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Tiotropium + Olodaterol
Respimat
Tiotropium + Olodaterol
Olodaterol
Respimat
Respimat
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion criteria:
- Diagnosis of chronic obstructive pulmonary disease.
- Relatively stable airway obstruction with post FEV1< 80% predicted normal and post FEV1/FVC <70%.
- Male or female Japanese patients, 40 years of age or older.
- Smoking history of more than 10 pack years.
Exclusion criteria:
- Significant disease other than COPD
- Clinically relevant abnormal lab values.
- History of asthma.
- Diagnosis of thyrotoxicosis
- Diagnosis of paroxysmal tachycardia
- History of myocardial infarction within 1 year of screening visit
- Unstable or life-threatening cardiac arrhythmia.
- Hospitalization for heart failure within the past year.
- Known active tuberculosis.
- Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
- History of life-threatening pulmonary obstruction.
- History of cystic fibrosis.
- Clinically evident bronchiectasis.
- History of significant alcohol or drug abuse.
- Thoracotomy with pulmonary resection
- Oral ß-adrenergics.
- Oral corticosteroid medication at unstable doses
- Regular use of daytime oxygen therapy for more than one hour per day
- Pulmonary rehabilitation program in the six weeks prior to the screening visit
- Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
- Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
- Pregnant or nursing women.
- Women of childbearing potential not using a highly effective method of birth control
- Patients who are unable to comply with pulmonary medication restrictions
- Patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc.
Sites / Locations
- 1237.22.81015 Boehringer Ingelheim Investigational Site
- 1237.22.81023 Boehringer Ingelheim Investigational Site
- 1237.22.81009 Boehringer Ingelheim Investigational Site
- 1237.22.81011 Boehringer Ingelheim Investigational Site
- 1237.22.81007 Boehringer Ingelheim Investigational Site
- 1237.22.81028 Boehringer Ingelheim Investigational Site
- 1237.22.81019 Boehringer Ingelheim Investigational Site
- 1237.22.81021 Boehringer Ingelheim Investigational Site
- 1237.22.81014 Boehringer Ingelheim Investigational Site
- 1237.22.81017 Boehringer Ingelheim Investigational Site
- 1237.22.81004 Boehringer Ingelheim Investigational Site
- 1237.22.81029 Boehringer Ingelheim Investigational Site
- 1237.22.81027 Boehringer Ingelheim Investigational Site
- 1237.22.81008 Boehringer Ingelheim Investigational Site
- 1237.22.81001 Boehringer Ingelheim Investigational Site
- 1237.22.81016 Boehringer Ingelheim Investigational Site
- 1237.22.81022 Boehringer Ingelheim Investigational Site
- 1237.22.81025 Boehringer Ingelheim Investigational Site
- 1237.22.81018 Boehringer Ingelheim Investigational Site
- 1237.22.81026 Boehringer Ingelheim Investigational Site
- 1237.22.81010 Boehringer Ingelheim Investigational Site
- 1237.22.81020 Boehringer Ingelheim Investigational Site
- 1237.22.81030 Boehringer Ingelheim Investigational Site
- 1237.22.81003 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Tiotropium + Olodaterol (high dose)
Olodaterol
Tiotropium + Olodaterol (low dose)
Arm Description
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Olodaterol solution for inhalation - RESPIMAT
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Outcomes
Primary Outcome Measures
Number (%) of Patients With Drug-related AEs
Number (%) of patients with drug-related Adverse Events (AEs).
Secondary Outcome Measures
FEV1 AUC0-3h Response
Forced Expiratory Volume in 1 second Area Under Curve (AUC0-3h) response. FEV1 AUC0-3h was calculated using the trapezoidal rule, divided by the duration (3 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Note: The Mean presented is the unadjusted mean.
Trough FEV1 Response
Trough Forced Expiratory Volume in 1 second Response. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements after 52 weeks. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Note: The Mean presented is the unadjusted mean.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01536262
Brief Title
Japan Long-term Safety for Tiotropium Plus Olodaterol
Official Title
A Randomised, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed-dose Combination (2.5µg / 5µg, 5µg / 5µg ) and Olodaterol (5 µg) Delivered by the RESPIMAT Inhaler in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
The primary objective of this study is to assess the safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tiotropium + Olodaterol (high dose)
Arm Type
Other
Arm Description
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Arm Title
Olodaterol
Arm Type
Other
Arm Description
Olodaterol solution for inhalation - RESPIMAT
Arm Title
Tiotropium + Olodaterol (low dose)
Arm Type
Other
Arm Description
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Intervention Type
Drug
Intervention Name(s)
Tiotropium + Olodaterol
Intervention Description
Tiotropium and Olodaterol FDC once daily inhalation
Intervention Type
Device
Intervention Name(s)
Respimat
Intervention Description
Respimat inhaler
Intervention Type
Drug
Intervention Name(s)
Tiotropium + Olodaterol
Intervention Description
Tiotropium and Olodaterol FDC once daily inhalation
Intervention Type
Drug
Intervention Name(s)
Olodaterol
Intervention Description
Olodaterol once daily inhalation
Intervention Type
Device
Intervention Name(s)
Respimat
Intervention Description
Respimat inhaler
Intervention Type
Device
Intervention Name(s)
Respimat
Intervention Description
Respimat inhaler
Primary Outcome Measure Information:
Title
Number (%) of Patients With Drug-related AEs
Description
Number (%) of patients with drug-related Adverse Events (AEs).
Time Frame
From first drug administration until 21 days after the last administration, upto 392 days
Secondary Outcome Measure Information:
Title
FEV1 AUC0-3h Response
Description
Forced Expiratory Volume in 1 second Area Under Curve (AUC0-3h) response. FEV1 AUC0-3h was calculated using the trapezoidal rule, divided by the duration (3 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Note: The Mean presented is the unadjusted mean.
Time Frame
Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks
Title
Trough FEV1 Response
Description
Trough Forced Expiratory Volume in 1 second Response. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements after 52 weeks. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Note: The Mean presented is the unadjusted mean.
Time Frame
Baseline and 1 h, 10 min pre-dose after 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Diagnosis of chronic obstructive pulmonary disease.
Relatively stable airway obstruction with post FEV1< 80% predicted normal and post FEV1/FVC <70%.
Male or female Japanese patients, 40 years of age or older.
Smoking history of more than 10 pack years.
Exclusion criteria:
Significant disease other than COPD
Clinically relevant abnormal lab values.
History of asthma.
Diagnosis of thyrotoxicosis
Diagnosis of paroxysmal tachycardia
History of myocardial infarction within 1 year of screening visit
Unstable or life-threatening cardiac arrhythmia.
Hospitalization for heart failure within the past year.
Known active tuberculosis.
Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
History of life-threatening pulmonary obstruction.
History of cystic fibrosis.
Clinically evident bronchiectasis.
History of significant alcohol or drug abuse.
Thoracotomy with pulmonary resection
Oral ß-adrenergics.
Oral corticosteroid medication at unstable doses
Regular use of daytime oxygen therapy for more than one hour per day
Pulmonary rehabilitation program in the six weeks prior to the screening visit
Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
Pregnant or nursing women.
Women of childbearing potential not using a highly effective method of birth control
Patients who are unable to comply with pulmonary medication restrictions
Patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1237.22.81015 Boehringer Ingelheim Investigational Site
City
Chiyoda-ku, Tokyo
Country
Japan
Facility Name
1237.22.81023 Boehringer Ingelheim Investigational Site
City
Chuo-ku, Tokyo
Country
Japan
Facility Name
1237.22.81009 Boehringer Ingelheim Investigational Site
City
Hamamatu, Shizuoka
Country
Japan
Facility Name
1237.22.81011 Boehringer Ingelheim Investigational Site
City
Kishiwada, Osaka
Country
Japan
Facility Name
1237.22.81007 Boehringer Ingelheim Investigational Site
City
Komatsu, Ishikawa
Country
Japan
Facility Name
1237.22.81028 Boehringer Ingelheim Investigational Site
City
Koriyama, Fukushima
Country
Japan
Facility Name
1237.22.81019 Boehringer Ingelheim Investigational Site
City
Koto-ku,Tokyo
Country
Japan
Facility Name
1237.22.81021 Boehringer Ingelheim Investigational Site
City
Kyoto, Kyoto
Country
Japan
Facility Name
1237.22.81014 Boehringer Ingelheim Investigational Site
City
Minami-ku, Kumamoto, Kumamoto
Country
Japan
Facility Name
1237.22.81017 Boehringer Ingelheim Investigational Site
City
Morioka, Iwate
Country
Japan
Facility Name
1237.22.81004 Boehringer Ingelheim Investigational Site
City
Nagaoka, Niigata
Country
Japan
Facility Name
1237.22.81029 Boehringer Ingelheim Investigational Site
City
Nagasaki, Nagasaki
Country
Japan
Facility Name
1237.22.81027 Boehringer Ingelheim Investigational Site
City
Osakasayama, Osaka
Country
Japan
Facility Name
1237.22.81008 Boehringer Ingelheim Investigational Site
City
Saku, Nagano-ken
Country
Japan
Facility Name
1237.22.81001 Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
Country
Japan
Facility Name
1237.22.81016 Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
Country
Japan
Facility Name
1237.22.81022 Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
Country
Japan
Facility Name
1237.22.81025 Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
Country
Japan
Facility Name
1237.22.81018 Boehringer Ingelheim Investigational Site
City
Setagaya-ku, Tokyo
Country
Japan
Facility Name
1237.22.81026 Boehringer Ingelheim Investigational Site
City
Tagajyo,Miyagi
Country
Japan
Facility Name
1237.22.81010 Boehringer Ingelheim Investigational Site
City
Takatsuki, Osaka
Country
Japan
Facility Name
1237.22.81020 Boehringer Ingelheim Investigational Site
City
Toyohashi, Aichi
Country
Japan
Facility Name
1237.22.81030 Boehringer Ingelheim Investigational Site
City
Unzen, Nagasaki
Country
Japan
Facility Name
1237.22.81003 Boehringer Ingelheim Investigational Site
City
Yokohama,Kanagawa
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
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Japan Long-term Safety for Tiotropium Plus Olodaterol
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