Japan Long-term Safety for Tiotropium Plus Olodaterol

June 19, 2015 updated by: Boehringer Ingelheim

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Tiotropium + Olodaterol (high dose)
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Device: Respimat
Respimat inhaler
Drug: Tiotropium + Olodaterol
Tiotropium and Olodaterol FDC once daily inhalation
OTHER: Olodaterol
Olodaterol solution for inhalation - RESPIMAT
Device: Respimat
Respimat inhaler
Drug: Olodaterol
Olodaterol once daily inhalation
OTHER: Tiotropium + Olodaterol (low dose)
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Device: Respimat
Respimat inhaler
Drug: Tiotropium + Olodaterol
Tiotropium and Olodaterol FDC once daily inhalation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1 AUC0-3h Response
Time Frame: 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.
Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks
Trough FEV1 Response
Time Frame: 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.
Baseline and 1 h, 10 min pre-dose after 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 16, 2012

First Posted (ESTIMATE)

February 22, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 15, 2015

Last Update Submitted That Met QC Criteria

June 19, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1237.22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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