A Study to Characterize Pharmacokinetics of Tiotropium + Olodaterol Fixed-dose Combination in Japanese Patients With COPD.

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Tiotropium (low dose) + Olodaterol; Drug: Tiotropium (high dose) + Olodaterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01703845

1237.24

Details and patient eligibility

About

The primary objective of this study is to assess pharmacokinetics of tiotropium + olodaterol fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Japanese patients with COPD.

Enrollment: 32 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=<30% of predicted normal and< 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. A marked baseline prolongation of QT/QTc interval
7. A history of additional risk factors for Torsade de Pointes (TdP)
8. History of myocardial infarction within 1 year of screening visit
9. Unstable or life-threatening cardiac arrhythmia
10. Hospitalization for heart failure within the past year
11. Known active tuberculosis
12. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
13. History of life-threatening pulmonary obstruction
14. History of cystic fibrosis
15. Clinically evident bronchiectasis
16. History of significant alcohol or drug abuse
17. Thoracotomy with pulmonary resection
18. Oral ß-adrenergics
19. Oral corticosteroid medication at unstable doses
20. Regular use of daytime oxygen therapy for more than one hour per day
21. Pulmonary rehabilitation program in the six weeks prior to the screening visit
22. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
23. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
24. Pregnant or nursing women
25. Women of childbearing potential not using a highly effective method of birth control
26. Patients who have previously been randomized in this study or are currently participating in another study
27. Patients who are unable to comply with pulmonary medication restrictions
28. Patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc
29. Patients being treated with medications that prolong the QT/QTc interval

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Tiotropium + Olodaterol (high dose)

Experimental group

Description:

Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT

Treatment:

Drug: Tiotropium (high dose) + Olodaterol

Tiotropium + Olodaterol (low dose)

Experimental group

Description:

Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT

Treatment:

Drug: Tiotropium (low dose) + Olodaterol