UMIN-CTR Clinical Trial

Basic information
Public title	Usefulluness of single inhalaer treatment with long acting muscarinic antagonist, long acting beta agosit, and inhaled corticosteroid in symptomatic patients with chronic obstructive pulmonary disease without asthma and exacerbation
Acronym	Triple therapy for symptomatic COPD without asthma and exacerbation
Scientific Title	Usefulluness of single inhalaer treatment with long acting muscarinic antagonist, long acting beta agosit, and inhaled corticosteroid in symptomatic patients with symptomatic chronic obstructive pulmonary disease without asthma and exacerbation
Scientific Title:Acronym	Triple therapy for symptomatic COPD without asthma and exacerbation
Region	Japan

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

Objectives
Narrative objectives1	GOLD guide line recommends triple therapy with dual long acting bronchodilator and inhaled corticosteroid in COPD patients with frequent exacerbation, while Japanese Respiratory Society guideline recommends such therapy for COPD patients with asthma. However, the usefullnes of triple therapy in symptomatic COPD patients without asthma and exacerbation is not clarified. To investigate the usefullness of triple therapy in in symptomatic COPD patients without asthma, we conducted a prospective study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in chronic COPD assesement test score and % forced expiratory capacity in 1 second before and 8 and 24 weeks after the initiation of triple therapy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	single inhaler with umeclidinium bromide, vilanterol trifenatate, and fulticasone furoate
Interventions/Control_2
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Symptomatic COPD patients who are recieving single inhaler treatment with long acting beta agonist and long acting muscarinic antagonist and do not have asthma and exacerbation history
Key exclusion criteria	Asmptomatic COPD patients, asthma COPD overlap patients, COPD patients with exacerbation history, COPD patients with malignancy, COPD patients with other serious medical conditions, and COPD patients who were judged to be unsuitable for this study by attending physicians
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Mikio Middle name Last name Toyoshima
Organization	Hamamatsu Rosai Hospital
Division name	Department of Respiratory Medicine
Zip code	430-8525
Address	25 Shogencho, Hamamatsu
TEL	0534621211
Email	mi-toyoshima@hamamatsuh.johas.go.jp

Public contact
Name of contact person	1st name Mikio Middle name Last name Toyoshima
Organization	Hamamtsu Rosai Hospital
Division name	Department of Respiratory Medicine
Zip code	430-8525
Address	25 Shogencho, Hamamatsu
TEL	0534621211
Homepage URL
Email	mi-toyoshima@hamamatsuh.johas.go.jp

Sponsor
Institute	Hamamatsu Rosai Hospital
Institute
Department

Funding Source
Organization	Hamamatsu Rosai Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hamamtsu Rosai Hospital
Address	25 Shogencho, Hamamatsu
Tel	0534621211
Email	mi-toyoshima@hamamatsuh.johas.go.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

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2020 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2020 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 23 Day
Last modified on	2020 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045494