Japan Long-term Safety for Tiotropium Plus Olodaterol

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Tiotropium + Olodaterol; Drug: Olodaterol; Device: Respimat

• Registration Number: NCT01536262
• Lead Sponsor: Boehringer Ingelheim

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-22
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Disposition First Submitted: 2014-04-03
• Disposition First Submitted QC: 2014-04-03
• Disposition First Posted: 2014-04-30
• Status Verified: 2015-06
• Results First Submitted: 2015-06-19
• Results First Submitted QC: 2015-06-19
• Last Update Submitted: 2015-06-19
• Results First Posted: 2015-07-15
• Last Update Posted: 2015-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tiotropium + Olodaterol (high dose)	Tiotropium + Olodaterol	Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Tiotropium + Olodaterol (high dose)	Respimat	Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Olodaterol	Olodaterol	Olodaterol solution for inhalation - RESPIMAT
Olodaterol	Respimat	Olodaterol solution for inhalation - RESPIMAT
Tiotropium + Olodaterol (low dose)	Respimat	Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Tiotropium + Olodaterol (low dose)	Tiotropium + Olodaterol	Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT

Primary Outcome Measures

Name	Time	Method
Number (%) of Patients With Drug-related AEs	From first drug administration until 21 days after the last administration, upto 392 days	Number (%) of patients with drug-related Adverse Events (AEs).

Secondary Outcome Measures

Name	Time	Method
FEV1 AUC0-3h Response	Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks	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.
Trough FEV1 Response	Baseline and 1 h, 10 min pre-dose after 52 weeks	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.

Trial Locations

Locations (24)

1237.22.81028 Boehringer Ingelheim Investigational Site; 🇯🇵 Koriyama, Fukushima, Japan

1237.22.81019 Boehringer Ingelheim Investigational Site; 🇯🇵 Koto-ku,Tokyo, Japan

1237.22.81010 Boehringer Ingelheim Investigational Site; 🇯🇵 Takatsuki, Osaka, Japan

1237.22.81017 Boehringer Ingelheim Investigational Site; 🇯🇵 Morioka, Iwate, Japan

1237.22.81015 Boehringer Ingelheim Investigational Site; 🇯🇵 Chiyoda-ku, Tokyo, Japan

1237.22.81004 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagaoka, Niigata, Japan

1237.22.81027 Boehringer Ingelheim Investigational Site; 🇯🇵 Osakasayama, Osaka, Japan

1237.22.81029 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagasaki, Nagasaki, Japan

1237.22.81020 Boehringer Ingelheim Investigational Site; 🇯🇵 Toyohashi, Aichi, 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

1237.22.81021 Boehringer Ingelheim Investigational Site; 🇯🇵 Kyoto, Kyoto, Japan

1237.22.81014 Boehringer Ingelheim Investigational Site; 🇯🇵 Minami-ku, Kumamoto, Kumamoto, 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

1237.22.81018 Boehringer Ingelheim Investigational Site; 🇯🇵 Setagaya-ku, Tokyo, Japan

1237.22.81026 Boehringer Ingelheim Investigational Site; 🇯🇵 Tagajyo,Miyagi, Japan

1237.22.81022 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1237.22.81025 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1237.22.81003 Boehringer Ingelheim Investigational Site; 🇯🇵 Yokohama,Kanagawa, Japan

1237.22.81030 Boehringer Ingelheim Investigational Site; 🇯🇵 Unzen, Nagasaki, Japan