Japan Long-term Safety for Tiotropium Plus Olodaterol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01536262
First received: February 16, 2012
Last updated: October 16, 2013
Last verified: October 2013

February 16, 2012
October 16, 2013
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: up to 52 weeks ] [ Designated as safety issue: No ]
  • FEV1 AUC0-3h [ Time Frame: 52 weeks ] [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01536262 on ClinicalTrials.gov Archive Site
Trough FEV1 [ Time Frame: 52 weeks ] [ Time Frame: 24 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 olodatrol (delivered by the RESPIMAT Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD).

Not Provided
Interventional
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 once daily inhalation
  • Drug: Olodaterol
    Olodaterol once daily inhalation
  • Tiotropium + Olodaterol (high dose)
    Tiotropiuml and Olodaterol FDC solution for inhalation - RESPIMAT
    Intervention: Drug: Tiotropium + Olodaterol
  • Olodaterol
    Olodaterol solution for inhalation - RESPIMAT
    Intervention: Drug: Olodaterol
  • Tiotropium + Olodaterol (low dose)
    Tiotropiuml and Olodaterol FDC solution for inhalation - RESPIMAT
    Intervention: Drug: Tiotropium + Olodaterol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01536262
1237.22
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2013

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