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

NCT02629965 | Completed Phase 3 Results

• 1 other identifier: 1237.33
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 43

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 6-minute Walk Distance [Meter]

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

• Average Number of Step Per Day (Step/Day)

  2 weeks prior to Week 6 per treatment

• Average Daily Duration (Minutes) of ≥ 4 Metabolic Equivalents (METs)

  2 weeks prior to Week 6 per treatment

• Average Daily Duration (Minutes) of ≥ 3 Metabolic Equivalents (METs)

  2 weeks prior to Week 6 per treatment

• Average Daily Duration (Minutes) of ≥ 2 Metabolic Equivalents (METs)

  2 weeks prior to Week 6 per treatment

Study Arms (2)

tiotropium + olodaterol

EXPERIMENTAL

inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning

Drug: tiotropium; Drug: olodaterol

tiotropium

ACTIVE COMPARATOR

inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning

Drug: tiotropium

Interventions

tiotropium DRUG

fixed dose combination

tiotropium + olodaterol

olodaterol DRUG

fixed dose combination

tiotropium + olodaterol

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (43)

Hiramatsu Internal and Respiratory Medicine Clinic

Aichi, Komaki, 485-0041, Japan

Location

National Hospital for Geriatric Medicine

Aichi, Obu, 474-8511, Japan

Location

Tosei General Hospital

Aichi, Seto, 489-8642, Japan

Location

Nishi Fukuoka Hospital

Fukuoka, Fukuoka, 819-8555, Japan

Location

Kirigaoka Tsuda Hospital

Fukuoka, Kitakyushu, 802-0052, Japan

Location

Osaki Internal and Respiratory Clinic

Fukuoka, Kitakyushu, 802-0083, Japan

Location

Kurume University Hospital

Fukuoka, Kurume, 830-0011, Japan

Location

Tohno Chuo Clinic

Gifu, Mizunami, 509-6134, Japan

Location

Mazda Hospital

Hiroshima, Aki-gun, 735-8585, Japan

Location

Teine Keijinkai Clinic

Hokkaido, Sapporo, 006-0811, Japan

Location

Hokkaido University Hospital

Hokkaido, Sapporo, 060-8648, Japan

Location

KKR Sapporo Medical Center

Hokkaido, Sapporo, 062-0931, Japan

Location

Japan Community Health Care Organization Hokkaido Hospital

Hokkaido, Sapporo, 062-8618, Japan

Location

Kobe City Medical Center General Hospital

Hyogo, Kobe, 650-0047, Japan

Location

Kobe City Hospital Organization Kobe City Medical Center West Hospital

Hyogo, Kobe, 653-0013, Japan

Location

Ibarakihigashi National Hospial

Ibaraki, Naka-gun, 319-1113, Japan

Location

Iwate Medical University Hospital

Iwate, Morioka, 020-8505, Japan

Location

Sakaide City Hospital

Kagawa, Sakaide, 762-8550, Japan

Location

Kagoshima University Medical And Dental Hospital

Kagoshima, Kagoshima, 890-8520, Japan

Location

Kokan Clinic

Kanagawa, Kawasaki, 210-0852, Japan

Location

Shin-yurigaoka General Hospital

Kanagawa, Kawasaki, 215-0026, Japan

Location

Showa University Fujigaoka Hospital

Kanagawa, Yokohama, 227-8501, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Rakuwakai Otowa Hospital

Kyoto, Kyoto, 607-8062, Japan

Location

Uji-Tokushukai Medical Center

Kyoto, Uji, 611-0041, Japan

Location

Matsusaka City Hospital

Mie, Matsusaka, 515-8544, Japan

Location

Tohoku University Hospital

Miyagi, Sendai, 980-8574, Japan

Location

Tohoku Rosai Hospital

Miyagi, Sendai, 981-8563, Japan

Location

Kishiwada City Hospital

Osaka, Kishiwada, 596-8501, Japan

Location

Kindai University Hospital

Osaka, Osakasayama, 589-8511, Japan

Location

Osaka City University Hospital

Osaka, Osaka, 545-8586, Japan

Location

National Hospital Organization Toneyama National Hospital

Osaka, Toyonaka, 560-8552, Japan

Location

Yao Tokushukai General Hospital

Osaka, Yao, 581-0011, Japan

Location

Shimane University Hospital

Shimane, Izumo, 693-8501, Japan

Location

Tenryu Hospital

Shizuoka, Hamamatsu, 434-8511, Japan

Location

Juntendo University Hospital

Tokyo, Bunkyo-ku, 113-8431, Japan

Location

The Respiratory Care Clinic, Nippon Medical School

Tokyo, Chiyoda-ku, 102-0074, Japan

Location

Nihonbashi Sakura Clinic

Tokyo, Chuo-ku, 103-0025, Japan

Location

Tokyo Medical University Hachioji Medical Center

Tokyo, Hachioji, 193-0998, Japan

Location

Nihon University Itabashi Hospital

Tokyo, Itabashi-ku, 173-8610, Japan

Location

Showa University Hospital

Tokyo, Shinagawa-ku, 142-8666, Japan

Location

Shinjuku Research Park Clinic

Tokyo, Shinjuku-ku, 169-0073, Japan

Location

Wakayama National Hospital

Wakayama, Hidaka-gun, 644-0044, Japan

Location

Related Publications (1)

• Minakata Y, Motegi T, Ueki J, Gon Y, Nakamura S, Anzai T, Hirata K, Ichinose M. Effect of tiotropium/olodaterol on sedentary and active time in patients with COPD: post hoc analysis of the VESUTO(R) study. Int J Chron Obstruct Pulmon Dis. 2019 Aug 7;14:1789-1801. doi: 10.2147/COPD.S208081. eCollection 2019.

  PMID: 31496678 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; olodaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 15, 2015
• Study Start: February 12, 2016
• Primary Completion: March 24, 2017
• Study Completion: April 17, 2017
• Last Updated: June 6, 2019
• Results First Posted: June 6, 2019

Record last verified: 2018-10

Locations

JP (43)