Comparing the Efficacy of Tiotropium + Olodaterol Fixed Dose Combination (FDC) Over Tiotropium in Improvement of Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese COPD Patients

Boehringer Ingelheim184 enrolled

Overview

This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6 weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

184

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tiotropium

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion criteria: * All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions. * All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator Forced expiratory volume in one second (FEV1) \< 80% of predicted normal and post-bronchodilator FEV1/forced vital capacity (FVC) \< 70% at Visit 1. * Male or female patients, aged \>= 40 years. * Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded. * Patients with score on the modified Medical Research Council (mMRC) \>= 1. * Patients who walk \< 400 meters of 6MWT and have a score on the modified Borg \>= 4 at the end of 6 minute walk test (6MWT) at Visit 2. * Patients must be able to perform technically acceptable pulmonary function tests (spirometry), to use the physical activity monitor and must be able to complete 6MWT during the study period as required in the protocol. * Patients must be able to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler. Exclusion criteria: * Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may put the patient at risk because of participation in the study, influence the results of the study and cause concern regarding the patient's ability to participate in the study. * Patients with clinically relevant abnormal baseline haematology, blood chemistry,urinalysis or creatinine \> x2 upper limit of normal (ULN) will be excluded regardless of clinical condition (a repeat laboratory evaluation can be conducted if deemed necessary by the investigator). * Patients with a current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. * Further exclusion criteria apply

Locations (43)

Hiramatsu Internal and Respiratory Medicine Clinic

Aichi, Komaki, Japan

National Hospital for Geriatric Medicine

Aichi, Obu, Japan

Tosei General Hospital

Aichi, Seto, Japan

Nishi Fukuoka Hospital

Fukuoka, Fukuoka, Japan

Kirigaoka Tsuda Hospital

Fukuoka, Kitakyushu, Japan

Osaki Internal and Respiratory Clinic

Outcomes

Primary Outcomes

Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose

At day 43 inspiratory capacity at rest measured at 60 minutes post-dose, after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.

Time frame: Day 43, 60 minutes post-dose after 6 weeks of each treatment

Secondary Outcomes

6-minute Walk Distance [Meter]

6-minute walk distance \[Meter\] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.

Time frame: Day 43, 60 minutes post-dose after 6 weeks of each treatment

Average Number of Step Per Day (Step/Day)

At day 43 adjusted mean (SE) of average number of step per day \[step/day\] treatment comparisons in measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.