Completed
A Randomised, Open-label, Parallel-group Trial to Assess Pharmacokinetics and Safety 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 Chronic Obstructive Pulmonary Disease (COPD)
What is being tested
Tiotropium (high dose) + Olodaterol
+ Tiotropium (low dose) + Olodaterol
Drug
Who is being recruted
Chronic Disease+5
+ Lung Diseases
+ Lung Diseases, Obstructive
Over 40 Years
+33 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: October 2012
Summary
Principal SponsorBoehringer Ingelheim
Last updated: July 15, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorBoehringer Ingelheim
Last updated: July 15, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive
Criteria
4 inclusion criteria required to participate
Diagnosis of chronic obstructive pulmonary disease
Male or female Japanese patients, 40 years of age or older
Relatively stable airway obstruction with post FEV1= < 30% of predicted normal and < 80% predicted normal and post FEV1/FVC < 70%
Smoking history of more than 10 pack years
29 exclusion criteria prevent from participating
A history of additional risk factors for Torsade de Pointes (TdP)
A marked baseline prolongation of QT/QTc interval
Clinically evident bronchiectasis
Clinically relevant abnormal lab values
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalTiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT
Group II
ExperimentalTiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
1237.24.24001 Boehringer Ingelheim Investigational Site
Toshima-ku, Tokyo, JapanOpen 1237.24.24001 Boehringer Ingelheim Investigational Site in Google MapsCompletedOne Study Center