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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium + Olodaterol (high dose) | Other | Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT |
|
| Olodaterol | Other | Olodaterol solution for inhalation - RESPIMAT |
|
| Tiotropium + Olodaterol (low dose) | Other | Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium + Olodaterol | Drug | Tiotropium and Olodaterol FDC once daily inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number (%) of Patients With Drug-related AEs | Number (%) of patients with drug-related Adverse Events (AEs). | From first drug administration until 21 days after the last administration, upto 392 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1237.22.81015 Boehringer Ingelheim Investigational Site | Chiyoda-ku, Tokyo | Japan | ||||
| 1237.22.81023 Boehringer Ingelheim Investigational Site |
This study was a 52-week multi-centre, randomised, double-blind and parallel-group design.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olodaterol (5 μg) | Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period. |
| FG001 | Tiotropium + Olodaterol (2.5 / 5 μg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Respimat | Device | Respimat inhaler |
|
| Tiotropium + Olodaterol | Drug | Tiotropium and Olodaterol FDC once daily inhalation |
|
| Olodaterol | Drug | Olodaterol once daily inhalation |
|
| Respimat | Device | Respimat inhaler |
|
| Respimat | Device | Respimat inhaler |
|
| Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks |
| 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. | Baseline and 1 h, 10 min pre-dose after 52 weeks |
| Chuo-ku, Tokyo |
| Japan |
| 1237.22.81009 Boehringer Ingelheim Investigational Site | Hamamatu, Shizuoka | Japan |
| 1237.22.81011 Boehringer Ingelheim Investigational Site | Kishiwada, Osaka | Japan |
| 1237.22.81007 Boehringer Ingelheim Investigational Site | Komatsu, Ishikawa | Japan |
| 1237.22.81028 Boehringer Ingelheim Investigational Site | Koriyama, Fukushima | Japan |
| 1237.22.81019 Boehringer Ingelheim Investigational Site | Koto-ku,Tokyo | Japan |
| 1237.22.81021 Boehringer Ingelheim Investigational Site | Kyoto, Kyoto | Japan |
| 1237.22.81014 Boehringer Ingelheim Investigational Site | Minami-ku, Kumamoto, Kumamoto | Japan |
| 1237.22.81017 Boehringer Ingelheim Investigational Site | Morioka, Iwate | Japan |
| 1237.22.81004 Boehringer Ingelheim Investigational Site | Nagaoka, Niigata | Japan |
| 1237.22.81029 Boehringer Ingelheim Investigational Site | Nagasaki, Nagasaki | Japan |
| 1237.22.81027 Boehringer Ingelheim Investigational Site | Osakasayama, Osaka | Japan |
| 1237.22.81008 Boehringer Ingelheim Investigational Site | Saku, Nagano-ken | Japan |
| 1237.22.81001 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1237.22.81016 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1237.22.81022 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1237.22.81025 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1237.22.81018 Boehringer Ingelheim Investigational Site | Setagaya-ku, Tokyo | Japan |
| 1237.22.81026 Boehringer Ingelheim Investigational Site | Tagajyo,Miyagi | Japan |
| 1237.22.81010 Boehringer Ingelheim Investigational Site | Takatsuki, Osaka | Japan |
| 1237.22.81020 Boehringer Ingelheim Investigational Site | Toyohashi, Aichi | Japan |
| 1237.22.81030 Boehringer Ingelheim Investigational Site | Unzen, Nagasaki | Japan |
| 1237.22.81003 Boehringer Ingelheim Investigational Site | Yokohama,Kanagawa | Japan |
Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
| FG002 | Tiotropium + Olodaterol (5 / 5 μg) | Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period. |
| COMPLETED |
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| NOT COMPLETED |
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Treated Set (TS): This patient set included all patients who received at least 1 dose of treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Olodaterol (5 μg) | Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period. |
| BG001 | Tiotropium + Olodaterol (2.5 / 5 μg) | Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period. |
| BG002 | Tiotropium + Olodaterol (5 / 5 μg) | Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number (%) of Patients With Drug-related AEs | Number (%) of patients with drug-related Adverse Events (AEs). | Treated set: This patient set included all patients who received at least 1 dose of treatment. | Posted | Number | percentage of participants | From first drug administration until 21 days after the last administration, upto 392 days |
|
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| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set (FAS): This patient set included all randomised patients who received at least 1 dose of treatment and had both non-missing baseline and at least 1 non-missing post-baseline efficacy measurement. Assignment to FAS was done after implementation of any data handling rules which set measurements to missing. | Posted | Mean | Standard Error | L | Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | 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 analysis set (FAS) | Posted | Mean | Standard Error | L | Baseline and 1 h, 10 min pre-dose after 52 weeks |
|
From first drug administration until 21 days after the last administration, upto 392 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olodaterol (5 μg) | Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period. | 5 | 41 | 21 | 41 | ||
| EG001 | Tiotropium + Olodaterol (2.5 / 5 μg) | Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period. | 6 | 40 | 20 | 40 | ||
| EG002 | Tiotropium + Olodaterol (5 / 5 μg) | Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period. | 3 | 41 | 24 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000611386 | tiotropium-olodaterol |
| C549647 | olodaterol |
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| Male |
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Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period. |
|
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| Units | Counts |
|---|---|
| Participants |
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