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Japan Long-term Safety for Tiotropium Plus Olodaterol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01536262
First Posted: February 22, 2012
Last Update Posted: July 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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).

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive Drug: Tiotropium + Olodaterol Device: Respimat Drug: Olodaterol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number (%) of Patients With Drug-related AEs [ Time Frame: From first drug administration until 21 days after the last administration, upto 392 days ]
    Number (%) of patients with drug-related Adverse Events (AEs).


Secondary Outcome Measures:
  • FEV1 AUC0-3h Response [ Time Frame: Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks ]

    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 [ Time Frame: Baseline and 1 h, 10 min pre-dose after 52 weeks ]

    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.



Enrollment: 122
Study Start Date: February 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tiotropium + Olodaterol (high dose)
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Drug: Tiotropium + Olodaterol
Tiotropium and Olodaterol FDC once daily inhalation
Device: Respimat
Respimat inhaler
Olodaterol
Olodaterol solution for inhalation - RESPIMAT
Drug: Olodaterol
Olodaterol once daily inhalation
Device: Respimat
Respimat inhaler
Tiotropium + Olodaterol (low dose)
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Drug: Tiotropium + Olodaterol
Tiotropium and Olodaterol FDC once daily inhalation
Device: Respimat
Respimat inhaler

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01536262


Locations
Japan
1237.22.81015 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan
1237.22.81023 Boehringer Ingelheim Investigational Site
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
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01536262     History of Changes
Other Study ID Numbers: 1237.22
First Submitted: February 16, 2012
First Posted: February 22, 2012
Results First Submitted: June 19, 2015
Results First Posted: July 15, 2015
Last Update Posted: July 15, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
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