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Japan Long-term Safety for Tiotropium Plus Olodaterol

NCT ID: NCT01536262

Last Updated: 2015-07-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Tiotropium + Olodaterol (high dose)

Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT

Group Type OTHER

Tiotropium + Olodaterol

Intervention Type DRUG

Tiotropium and Olodaterol FDC once daily inhalation

Respimat

Intervention Type DEVICE

Respimat inhaler

Olodaterol

Olodaterol solution for inhalation - RESPIMAT

Group Type OTHER

Olodaterol

Intervention Type DRUG

Olodaterol once daily inhalation

Respimat

Intervention Type DEVICE

Respimat inhaler

Tiotropium + Olodaterol (low dose)

Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT

Group Type OTHER

Tiotropium + Olodaterol

Intervention Type DRUG

Tiotropium and Olodaterol FDC once daily inhalation

Respimat

Intervention Type DEVICE

Respimat inhaler

Interventions

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Tiotropium + Olodaterol

Tiotropium and Olodaterol FDC once daily inhalation

Intervention Type DRUG

Respimat

Respimat inhaler

Intervention Type DEVICE

Tiotropium + Olodaterol

Tiotropium and Olodaterol FDC once daily inhalation

Intervention Type DRUG

Olodaterol

Olodaterol once daily inhalation

Intervention Type DRUG

Respimat

Respimat inhaler

Intervention Type DEVICE

Respimat

Respimat inhaler

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of chronic obstructive pulmonary disease.
2. Relatively stable airway obstruction with post FEV1\< 80% predicted normal and post FEV1/FVC \<70%.
3. Male or female Japanese patients, 40 years of age or older.
4. Smoking history of more than 10 pack years.

Exclusion Criteria

1. Significant disease other than COPD
2. Clinically relevant abnormal lab values.
3. History of asthma.
4. Diagnosis of thyrotoxicosis
5. Diagnosis of paroxysmal tachycardia
6. History of myocardial infarction within 1 year of screening visit
7. Unstable or life-threatening cardiac arrhythmia.
8. Hospitalization for heart failure within the past year.
9. Known active tuberculosis.
10. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
11. History of life-threatening pulmonary obstruction.
12. History of cystic fibrosis.
13. Clinically evident bronchiectasis.
14. History of significant alcohol or drug abuse.
15. Thoracotomy with pulmonary resection
16. Oral ß-adrenergics.
17. Oral corticosteroid medication at unstable doses
18. Regular use of daytime oxygen therapy for more than one hour per day
19. Pulmonary rehabilitation program in the six weeks prior to the screening visit
20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
22. Pregnant or nursing women.
23. Women of childbearing potential not using a highly effective method of birth control
24. Patients who are unable to comply with pulmonary medication restrictions
25. Patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1237.22.81015 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, , Japan

Site Status

1237.22.81023 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

1237.22.81009 Boehringer Ingelheim Investigational Site

Hamamatu, Shizuoka, , Japan

Site Status

1237.22.81011 Boehringer Ingelheim Investigational Site

Kishiwada, Osaka, , Japan

Site Status

1237.22.81007 Boehringer Ingelheim Investigational Site

Komatsu, Ishikawa, , Japan

Site Status

1237.22.81028 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, , Japan

Site Status

1237.22.81019 Boehringer Ingelheim Investigational Site

Koto-ku,Tokyo, , Japan

Site Status

1237.22.81021 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, , Japan

Site Status

1237.22.81014 Boehringer Ingelheim Investigational Site

Minami-ku, Kumamoto, Kumamoto, , Japan

Site Status

1237.22.81017 Boehringer Ingelheim Investigational Site

Morioka, Iwate, , Japan

Site Status

1237.22.81004 Boehringer Ingelheim Investigational Site

Nagaoka, Niigata, , Japan

Site Status

1237.22.81029 Boehringer Ingelheim Investigational Site

Nagasaki, Nagasaki, , Japan

Site Status

1237.22.81027 Boehringer Ingelheim Investigational Site

Osakasayama, Osaka, , Japan

Site Status

1237.22.81008 Boehringer Ingelheim Investigational Site

Saku, Nagano-ken, , Japan

Site Status

1237.22.81001 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1237.22.81016 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1237.22.81022 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1237.22.81025 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1237.22.81018 Boehringer Ingelheim Investigational Site

Setagaya-ku, Tokyo, , Japan

Site Status

1237.22.81026 Boehringer Ingelheim Investigational Site

Tagajyo,Miyagi, , Japan

Site Status

1237.22.81010 Boehringer Ingelheim Investigational Site

Takatsuki, Osaka, , Japan

Site Status

1237.22.81020 Boehringer Ingelheim Investigational Site

Toyohashi, Aichi, , Japan

Site Status

1237.22.81030 Boehringer Ingelheim Investigational Site

Unzen, Nagasaki, , Japan

Site Status

1237.22.81003 Boehringer Ingelheim Investigational Site

Yokohama,Kanagawa, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1237.22

Identifier Type: -

Identifier Source: org_study_id

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