Japan Long-term Safety for Tiotropium Plus Olodaterol

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536262
• Other study ID #: 1237.22
• Status: Completed
• Phase: Phase 3
• First received: February 16, 2012
• Last updated: June 19, 2015
• Start date: February 2012
• Est. completion date: September 2013

Study information

• Verified date: June 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium + Olodaterol
Tiotropium and Olodaterol FDC once daily inhalation

Device:
• Respimat
Respimat inhaler

Drug:
• Tiotropium + Olodaterol
Tiotropium and Olodaterol FDC once daily inhalation
• Olodaterol
Olodaterol once daily inhalation

Device:
• Respimat
Respimat inhaler
• Respimat
Respimat inhaler

Locations

Country	Name	City	State
Japan	1237.22.81015 Boehringer Ingelheim Investigational Site	Chiyoda-ku, Tokyo
Japan	1237.22.81023 Boehringer Ingelheim Investigational Site	Chuo-ku, Tokyo
Japan	1237.22.81009 Boehringer Ingelheim Investigational Site	Hamamatu, Shizuoka
Japan	1237.22.81011 Boehringer Ingelheim Investigational Site	Kishiwada, Osaka
Japan	1237.22.81007 Boehringer Ingelheim Investigational Site	Komatsu, Ishikawa
Japan	1237.22.81028 Boehringer Ingelheim Investigational Site	Koriyama, Fukushima
Japan	1237.22.81019 Boehringer Ingelheim Investigational Site	Koto-ku,Tokyo
Japan	1237.22.81021 Boehringer Ingelheim Investigational Site	Kyoto, Kyoto
Japan	1237.22.81014 Boehringer Ingelheim Investigational Site	Minami-ku, Kumamoto, Kumamoto
Japan	1237.22.81017 Boehringer Ingelheim Investigational Site	Morioka, Iwate
Japan	1237.22.81004 Boehringer Ingelheim Investigational Site	Nagaoka, Niigata
Japan	1237.22.81029 Boehringer Ingelheim Investigational Site	Nagasaki, Nagasaki
Japan	1237.22.81027 Boehringer Ingelheim Investigational Site	Osakasayama, Osaka
Japan	1237.22.81008 Boehringer Ingelheim Investigational Site	Saku, Nagano-ken
Japan	1237.22.81001 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1237.22.81016 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1237.22.81022 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1237.22.81025 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1237.22.81018 Boehringer Ingelheim Investigational Site	Setagaya-ku, Tokyo
Japan	1237.22.81026 Boehringer Ingelheim Investigational Site	Tagajyo,Miyagi
Japan	1237.22.81010 Boehringer Ingelheim Investigational Site	Takatsuki, Osaka
Japan	1237.22.81020 Boehringer Ingelheim Investigational Site	Toyohashi, Aichi
Japan	1237.22.81030 Boehringer Ingelheim Investigational Site	Unzen, Nagasaki
Japan	1237.22.81003 Boehringer Ingelheim Investigational Site	Yokohama,Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number (%) of Patients With Drug-related AEs	Number (%) of patients with drug-related Adverse Events (AEs).	From first drug administration until 21 days after the last administration, upto 392 days	No
Secondary	FEV1 AUC0-3h Response	Forced Expiratory Volume in 1 second Area Under Curve (AUC0-3h) response. FEV1 AUC0-3h was calculated using the trapezoidal rule, divided by the duration (3 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.; Note: The Mean presented is the unadjusted mean.	Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks	No
Secondary	Trough FEV1 Response	Trough Forced Expiratory Volume in 1 second Response. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements after 52 weeks. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.; Note: The Mean presented is the unadjusted mean.	Baseline and 1 h, 10 min pre-dose after 52 weeks	No

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