Japan Long-term Safety for Tiotropium Plus Olodaterol

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
First received: February 16, 2012
Last updated: December 18, 2014
Last verified: December 2014

February 16, 2012
December 18, 2014
February 2012
September 2013   (final data collection date for primary outcome measure)
  • All adverse events (including physical examination) until the end of study [ Time Frame: 55 weeks ] [ Designated as safety issue: No ]
  • Vital signs: pulse rate and blood pressure (seated) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Routine blood chemistry, haematology and urinalysis [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 12-lead ECG [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to discontinuation from study drug [ Time Frame: 55 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01536262 on ClinicalTrials.gov Archive Site
  • FEV1 AUC0-3h [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Trough FEV1 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • FEV1AUC0-3h [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Trough FEV1 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Japan Long-term Safety for Tiotropium Plus Olodaterol
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)

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).

Not Provided
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: Tiotropium + Olodaterol
    Tiotropium and Olodaterol FDC once daily inhalation
  • Device: Respimat
    Respimat inhaler
  • Drug: Olodaterol
    Olodaterol once daily inhalation
  • Tiotropium + Olodaterol (high dose)
    Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
    • Drug: Tiotropium + Olodaterol
    • Device: Respimat
  • Olodaterol
    Olodaterol solution for inhalation - RESPIMAT
    • Drug: Olodaterol
    • Device: Respimat
  • Tiotropium + Olodaterol (low dose)
    Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
    • Drug: Tiotropium + Olodaterol
    • Device: Respimat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
40 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP