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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Randomised, Double-blinded, Active-controlled 2-way Cross Over Trial to Assess the Effects of 6 Weeks Treatment of Once Daily Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Delivered by RESPIMAT Inhaler Compared With Tiotropium Delivered by RESPIMAT Inhaler on Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629965
• Other study ID #: 1237.33
• Status: Completed
• Phase: Phase 3
• Start date: February 12, 2016
• Est. completion date: April 17, 2017

Study information

• Verified date: October 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: April 17, 2017
• Est. primary completion date: March 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• tiotropium
fixed dose combination
• olodaterol
fixed dose combination
• tiotropium

Locations

Country	Name	City	State
Japan	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	Fukuoka, Kitakyushu
Japan	Kurume University Hospital	Fukuoka, Kurume
Japan	Tohno Chuo Clinic	Gifu, Mizunami
Japan	Mazda Hospital	Hiroshima, Aki-gun
Japan	Hokkaido University Hospital	Hokkaido, Sapporo
Japan	Japan Community Health Care Organization Hokkaido Hospital	Hokkaido, Sapporo
Japan	KKR Sapporo Medical Center	Hokkaido, Sapporo
Japan	Teine Keijinkai Clinic	Hokkaido, Sapporo
Japan	Kobe City Hospital Organization Kobe City Medical Center West Hospital	Hyogo, Kobe
Japan	Kobe City Medical Center General Hospital	Hyogo, Kobe
Japan	Ibarakihigashi National Hospial	Ibaraki, Naka-gun
Japan	Iwate Medical University Hospital	Iwate, Morioka
Japan	Sakaide City Hospital	Kagawa, Sakaide
Japan	Kagoshima University Medical And Dental Hospital	Kagoshima, Kagoshima
Japan	Kokan Clinic	Kanagawa, Kawasaki
Japan	Shin-yurigaoka General Hospital	Kanagawa, Kawasaki
Japan	Showa University Fujigaoka Hospital	Kanagawa, Yokohama
Japan	Kyoto University Hospital	Kyoto, Kyoto
Japan	Rakuwakai Otowa Hospital	Kyoto, Kyoto
Japan	Uji-Tokushukai Medical Center	Kyoto, Uji
Japan	Matsusaka City Hospital	Mie, Matsusaka
Japan	Tohoku Rosai Hospital	Miyagi, Sendai
Japan	Tohoku University Hospital	Miyagi, Sendai
Japan	Kishiwada City Hospital	Osaka, Kishiwada
Japan	Osaka City University Hospital	Osaka, Osaka
Japan	Kindai University Hospital	Osaka, Osakasayama
Japan	National Hospital Organization Toneyama National Hospital	Osaka, Toyonaka
Japan	Yao Tokushukai General Hospital	Osaka, Yao
Japan	Shimane University Hospital	Shimane, Izumo
Japan	Tenryu Hospital	Shizuoka, Hamamatsu
Japan	Juntendo University Hospital	Tokyo, Bunkyo-ku
Japan	The Respiratory Care Clinic, Nippon Medical School	Tokyo, Chiyoda-ku
Japan	Nihonbashi Sakura Clinic	Tokyo, Chuo-ku
Japan	Tokyo Medical University Hachioji Medical Center	Tokyo, Hachioji
Japan	Nihon University Itabashi Hospital	Tokyo, Itabashi-ku
Japan	Showa University Hospital	Tokyo, Shinagawa-ku
Japan	Shinjuku Research Park Clinic	Tokyo, Shinjuku-ku
Japan	Wakayama National Hospital	Wakayama, Hidaka-gun

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 43, 60 minutes post-dose after 6 weeks of each treatment
Secondary	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.	Day 43, 60 minutes post-dose after 6 weeks of each treatment
Secondary	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.	2 weeks prior to Week 6 per treatment
Secondary	Average Daily Duration (Minutes) of = 4 Metabolic Equivalents (METs)	At day 43 adjusted mean (SE) of average daily duration [minute] of = 4 METs treatment comparisons measured by the activity monitor in the 2 weeks prior to week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.	2 weeks prior to Week 6 per treatment
Secondary	Average Daily Duration (Minutes) of = 3 Metabolic Equivalents (METs)	At day 43 adjusted mean (SE) of average daily duration [minute] of = 3 METs treatment comparisons 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.	2 weeks prior to Week 6 per treatment
Secondary	Average Daily Duration (Minutes) of = 2 Metabolic Equivalents (METs)	At day 43 adjusted mean (SE) of average daily duration [minute] of = 2 METs treatment comparison 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.	2 weeks prior to Week 6 per treatment
Secondary	Average Daily Active Strength (Metabolic Equivalents*Minutes) of = 3 METs	At day 43 adjusted mean (SE) of average daily active strength [METs x minute] of >=3 METs treatment comparisons 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.	2 weeks prior to Week 6 per treatment
Secondary	60 Minutes Post-dose Slow Vital Capacity (SVC) (in Litre)	At day 43 adjusted mean (SE) of 60 minute post-dose slow vital capacity [Litre] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.	Day 43, 60 minutes post-dose after 6 weeks of each treatment
Secondary	30 Minutes Post-dose Forced Expiratory Volume in One Second (FEV1) (in Litre)	At day 43 adjusted mean (SE) of 30 minute post-dose forced expiratory volume in one second (FEV1) [Litre] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.	Day 43, 30 minutes post-dose after 6 weeks of each treatment
Secondary	30 Minutes Post-dose Forced Vital Capacity (FVC) (in Litre)	At day 43 adjusted mean (SE) of 30 minute post-dose forced vital capacity (FVC) [Litre] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.	Day 43, 30 minutes post-dose after 6 weeks of each treatment

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