UMIN-CTR Clinical Trial

Basic information
Public title	The effect of the combination treatment with tiotropium and olodaterol compared to tiotropium on symptoms, respiratory functions and physical activity in maintenance naive Japanese patient with COPD
Acronym	The effect of the combination treatment with tiotropium and olodaterol compared to tiotropium on symptoms, respiratory functions and physical activity in maintenance naive Japanese patient with COPD
Scientific Title	The effect of the combination treatment with tiotropium and olodaterol compared to tiotropium on symptoms, respiratory functions and physical activity in maintenance naive Japanese patient with COPD
Scientific Title:Acronym	The effect of the combination treatment with tiotropium and olodaterol compared to tiotropium on symptoms, respiratory functions and physical activity in maintenance naive Japanese patient with COPD
Region	Japan

Condition
Condition	COPD (Chronic obstructive pulmonary disease)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of the combination treatment with tiotropium and olodaterol compared to tiotropium on symptoms, respiratory functions and physical activity in maintenance naive Japanese patient with COPD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Peak FEV1 (post 1 hour inhalation with the combination of tiotropium and olodaterol or tiotropium)
Key secondary outcomes	1.Physical activity (triaxial accelerometer) on before and after 12 weeks treatment 2.Quality of life(CAT) on before and after 12 weeks treatment 3.Inspiratory capacity on before and after 12 weeks treatment 4.TDI scale (dyspnea) on before and after 12 weeks treatment 5.6MWD and modified Borg scale scores on before and after 12 weeks treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Interventions: combination treatment with tiotropium and olodaterol for 12 weeks
Interventions/Control_2	Control: treatment with tiotropium for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	1.Patients with COPD (FEV1/FVC<70%) and %FEV1<80% 2.Current or past smokers 3.Maintenance treatment naive patients
Key exclusion criteria	1.Patients who have bronchial asthma 2.Patients who are able to examine a pulmonary function test 3.Patients who are disturbed in walk ability or have a bone fracture 4.Patients who have experiences of exacerbation of COPD within 1 month 5.Patients with paroxysmal tachycardia (over 100 / min) and life threatening arrhythmia 6.Patients who have experiences of acute myocardial infarction or heart failure within 1 year 7.Patients who have experiences of malignant tumor ( excluding basal cell carcinoma or epithelial cancer of skin) within 5 years 8.Patients who do not understand purpose or method of the study 9.Patients with dementia 10.Patients who are being treated for depression and neurosis 11.Patients who have angle-closure glaucoma, benign prostatic hyperplasia with dysuria and hypersensitivity to atropine and its analogous substances or components of the drug 12.Patients who are judged not to be suitable as subjects
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Koichiro Middle name Last name Takahashi
Organization	Saga University
Division name	Faculty of medicine, department of internal medicine, Division of respiratory medicine,
Zip code	8498501
Address	5-1-1 Nabashima, Saga, Saga Prefecture, JAPAN
TEL	0952-34-2369
Email	takahak@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Koichiro Middle name Last name Takahashi
Organization	Saga University
Division name	Faculty of medicine, department of internal medicine, Division of respiratory medicine,
Zip code	8498501
Address	5-1-1 Nabashima, Saga, Saga Prefecture, JAPAN
TEL	0952-34-2369
Homepage URL
Email	takahak@cc.saga-u.ac.jp

Sponsor
Institute	Saga University
Institute
Department

Funding Source
Organization	Nippon Boehringer Ingelheim Co, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saga university Clinical research center
Address	5-1-1, Nabeshima, Saga
Tel	0952343400
Email	clinstudycenter@mail.admin.saga-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	佐賀大学医学部附属病院（佐賀県）Saga University Hospital 久留米大学病院（福岡県）Kurume University Hospital 国立病院機構福岡病院（福岡県）National hospital organization Fukuoka hospital 佐賀県医療センター好生館（佐賀県）Saga prefectural medical center Koseikan 地域医療推進機構佐賀中部病院（佐賀県）Japan Community Health Care Organization Saga central hospital 高邦会高木病院（福岡県）Kouhoukai Takagi hospital

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 29 Day

Related information
URL releasing protocol	https://www.dovepress.com/first-line-treatment-with-tiotropiumolodaterol-improves-physical-activ-pee
Publication of results	Published

Result
URL related to results and publications	https://www.dovepress.com/first-line-treatment-with-tiotropiumolodaterol-improves-physical-activ-pee
Number of participants that the trial has enrolled	80
Results	Tiotropium/olodaterol treatment reduced the duration of physical activity with 1.0-1.5METs(regression coefficient,-43.6 [95%CI -84.1, -3.1], p=0.04)in a multiple regression model adjusted for cofounding factors such as age, FEV1, total CAT scores, 6MWD, and TDI.
Results date posted	2021 Year 11 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	This study included in 38 cases of T/O and 37 cases of T group. Mean age was 69.8 year old in T/O, 70.4 years old in T group.
Participant flow	These patients were randomized into T/O or T group.
Adverse events	There was no severe adverse events.
Outcome measures	They are evaluated pulmonary function, transitional dyspnea score, CAT score and physical activity before and after treatment for 12 weeks.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 01 Month 30 Day
Date of IRB	2017 Year 03 Month 06 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2019 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 04 Month 29 Day
Last modified on	2021 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031159