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

March 1, 2019 updated by: Boehringer Ingelheim

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)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Aichi, Komaki, Japan, 485-0041
        • Hiramatsu Internal and Respiratory Medicine Clinic
      • Aichi, Obu, Japan, 474-8511
        • National Hospital for Geriatric Medicine
      • Aichi, Seto, Japan, 489-8642
        • Tosei General Hospital
      • Fukuoka, Fukuoka, Japan, 819-8555
        • Nishi Fukuoka Hospital
      • Fukuoka, Kitakyushu, Japan, 802-0052
        • Kirigaoka Tsuda Hospital
      • Fukuoka, Kitakyushu, Japan, 802-0083
        • Osaki Internal and Respiratory Clinic
      • Fukuoka, Kurume, Japan, 830-0011
        • Kurume University Hospital
      • Gifu, Mizunami, Japan, 509-6134
        • Tohno Chuo Clinic
      • Hiroshima, Aki-gun, Japan, 735-8585
        • Mazda Hospital
      • Hokkaido, Sapporo, Japan, 060-8648
        • Hokkaido University Hospital
      • Hokkaido, Sapporo, Japan, 062-8618
        • Japan Community Health care Organization Hokkaido Hospital
      • Hokkaido, Sapporo, Japan, 006-0811
        • Teine Keijinkai Clinic
      • Hokkaido, Sapporo, Japan, 062-0931
        • KKR Sapporo Medical Center
      • Hyogo, Kobe, Japan, 650-0047
        • Kobe City Medical Center General Hospital
      • Hyogo, Kobe, Japan, 653-0013
        • Kobe City Hospital Organization Kobe City Medical Center West Hospital
      • Ibaraki, Naka-gun, Japan, 319-1113
        • Ibarakihigashi National Hospial
      • Iwate, Morioka, Japan, 020-8505
        • Iwate Medical University Hospital
      • Kagawa, Sakaide, Japan, 762-8550
        • Sakaide City Hospital
      • Kagoshima, Kagoshima, Japan, 890-8520
        • Kagoshima University Medical and Dental Hospital
      • Kanagawa, Kawasaki, Japan, 210-0852
        • Kokan Clinic
      • Kanagawa, Kawasaki, Japan, 215-0026
        • Shin-yurigaoka General Hospital
      • Kanagawa, Yokohama, Japan, 227-8501
        • Showa University Fujigaoka Hospital
      • Kyoto, Kyoto, Japan, 606-8507
        • Kyoto University Hospital
      • Kyoto, Kyoto, Japan, 607-8062
        • Rakuwakai Otowa Hospital
      • Kyoto, Uji, Japan, 611-0041
        • Uji-Tokushukai Medical Center
      • Mie, Matsusaka, Japan, 515-8544
        • Matsusaka City Hospital
      • Miyagi, Sendai, Japan, 980-8574
        • Tohoku University Hospital
      • Miyagi, Sendai, Japan, 981-8563
        • Tohoku Rosai Hospital
      • Osaka, Kishiwada, Japan, 596-8501
        • Kishiwada City Hospital
      • Osaka, Osaka, Japan, 545-8586
        • Osaka City University Hospital
      • Osaka, Osakasayama, Japan, 589-8511
        • Kindai University Hospital
      • Osaka, Toyonaka, Japan, 560-8552
        • National Hospital Organization Toneyama National Hospital
      • Osaka, Yao, Japan, 581-0011
        • Yao Tokushukai General Hospital
      • Shimane, Izumo, Japan, 693-8501
        • Shimane University Hospital
      • Shizuoka, Hamamatsu, Japan, 434-8511
        • Tenryu Hospital
      • Tokyo, Bunkyo-ku, Japan, 113-8431
        • Juntendo University Hospital
      • Tokyo, Chiyoda-ku, Japan, 102-0074
        • The Respiratory Care Clinic, Nippon Medical School
      • Tokyo, Chuo-ku, Japan, 103-0025
        • Nihonbashi Sakura Clinic
      • Tokyo, Hachioji, Japan, 193-0998
        • Tokyo Medical University Hachioji Medical Center
      • Tokyo, Itabashi-ku, Japan, 173-8610
        • Nihon University Itabashi Hospital
      • Tokyo, Shinagawa-ku, Japan, 142-8666
        • Showa University Hospital
      • Tokyo, Shinjuku-ku, Japan, 169-0073
        • Shinjuku Research Park Clinic
      • Wakayama, Hidaka-gun, Japan, 644-0044
        • Wakayama National Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: tiotropium + olodaterol
inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning
Drug: tiotropium
Drug: tiotropium
fixed dose combination
Drug: olodaterol
fixed dose combination
Active Comparator: tiotropium
inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning
Drug: tiotropium
Drug: tiotropium
fixed dose combination

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose
Time Frame: Day 43, 60 minutes post-dose after 6 weeks of each treatment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
6-minute Walk Distance [Meter]
Time Frame: Day 43, 60 minutes post-dose after 6 weeks of each treatment
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
Average Number of Step Per Day (Step/Day)
Time Frame: 2 weeks prior to Week 6 per treatment
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
Average Daily Duration (Minutes) of ≥ 4 Metabolic Equivalents (METs)
Time Frame: 2 weeks prior to Week 6 per treatment
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
Average Daily Duration (Minutes) of ≥ 3 Metabolic Equivalents (METs)
Time Frame: 2 weeks prior to Week 6 per treatment
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
Average Daily Duration (Minutes) of ≥ 2 Metabolic Equivalents (METs)
Time Frame: 2 weeks prior to Week 6 per treatment
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
Average Daily Active Strength (Metabolic Equivalents*Minutes) of ≥ 3 METs
Time Frame: 2 weeks prior to Week 6 per treatment
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
60 Minutes Post-dose Slow Vital Capacity (SVC) (in Litre)
Time Frame: Day 43, 60 minutes post-dose after 6 weeks of each treatment
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
30 Minutes Post-dose Forced Expiratory Volume in One Second (FEV1) (in Litre)
Time Frame: Day 43, 30 minutes post-dose after 6 weeks of each treatment
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
30 Minutes Post-dose Forced Vital Capacity (FVC) (in Litre)
Time Frame: Day 43, 30 minutes post-dose after 6 weeks of each treatment
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 17, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1237.33

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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