Japan Long-term Safety for Tiotropium Plus Olodaterol

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Olodaterol; Device: Respimat; Drug: Tiotropium + Olodaterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01536262

1237.22

Details and patient eligibility

About

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).

Enrollment: 122 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 3 patient groups

Tiotropium + Olodaterol (high dose)

Other group

Description:

Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT

Treatment:

Drug: Tiotropium + Olodaterol

Device: Respimat

Drug: Tiotropium + Olodaterol

Device: Respimat

Device: Respimat

Olodaterol

Other group

Description:

Olodaterol solution for inhalation - RESPIMAT

Treatment:

Device: Respimat

Drug: Olodaterol

Device: Respimat

Device: Respimat

Tiotropium + Olodaterol (low dose)

Other group

Description:

Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT

Treatment:

Drug: Tiotropium + Olodaterol

Device: Respimat

Drug: Tiotropium + Olodaterol

Device: Respimat

Device: Respimat