Clinical trial NCT01536262: Japan Long-term Safety for Tiotropium Plus Olodaterol
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 122
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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.

Primary outcomes:
measure: Number (%) of Patients With Drug-related AEs
timeFrame: From first drug administration until 21 days after the last administration, upto 392 days
Secondary outcomes:
measure: FEV1 AUC0-3h Response
timeFrame: Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks
measure: Trough FEV1 Response
timeFrame: Baseline and 1 h, 10 min pre-dose after 52 weeks
Other outcomes:
Locations:
city: Chiyoda-ku, Tokyo
country: Japan
facility: 1237.22.81015 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: 1237.22.81023 Boehringer Ingelheim Investigational Site
city: Hamamatu, Shizuoka
country: Japan
facility: 1237.22.81009 Boehringer Ingelheim Investigational Site
city: Kishiwada, Osaka
country: Japan
facility: 1237.22.81011 Boehringer Ingelheim Investigational Site
city: Komatsu, Ishikawa
country: Japan
facility: 1237.22.81007 Boehringer Ingelheim Investigational Site
city: Koriyama, Fukushima
country: Japan
facility: 1237.22.81028 Boehringer Ingelheim Investigational Site
city: Koto-ku,Tokyo
country: Japan
facility: 1237.22.81019 Boehringer Ingelheim Investigational Site
city: Kyoto, Kyoto
country: Japan
facility: 1237.22.81021 Boehringer Ingelheim Investigational Site
city: Minami-ku, Kumamoto, Kumamoto
country: Japan
facility: 1237.22.81014 Boehringer Ingelheim Investigational Site
city: Morioka, Iwate
country: Japan
facility: 1237.22.81017 Boehringer Ingelheim Investigational Site
city: Nagaoka, Niigata
country: Japan
facility: 1237.22.81004 Boehringer Ingelheim Investigational Site
city: Nagasaki, Nagasaki
country: Japan
facility: 1237.22.81029 Boehringer Ingelheim Investigational Site
city: Osakasayama, Osaka
country: Japan
facility: 1237.22.81027 Boehringer Ingelheim Investigational Site
city: Saku, Nagano-ken
country: Japan
facility: 1237.22.81008 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1237.22.81001 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1237.22.81016 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1237.22.81022 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1237.22.81025 Boehringer Ingelheim Investigational Site
city: Setagaya-ku, Tokyo
country: Japan
facility: 1237.22.81018 Boehringer Ingelheim Investigational Site
city: Tagajyo,Miyagi
country: Japan
facility: 1237.22.81026 Boehringer Ingelheim Investigational Site
city: Takatsuki, Osaka
country: Japan
facility: 1237.22.81010 Boehringer Ingelheim Investigational Site
city: Toyohashi, Aichi
country: Japan
facility: 1237.22.81020 Boehringer Ingelheim Investigational Site
city: Unzen, Nagasaki
country: Japan
facility: 1237.22.81030 Boehringer Ingelheim Investigational Site
city: Yokohama,Kanagawa
country: Japan
facility: 1237.22.81003 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: