UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of Enerziar and Trelegy, Single inhaler triple therapy (SITT), in asthma (2)
Acronym	Comparison of Enerziar and Trelegy, Single inhaler triple therapy (SITT), in asthma (2)
Scientific Title	Comparison of Enerziar and Trelegy, Single inhaler triple therapy (SITT), in asthma (2)
Scientific Title:Acronym	Comparison of Enerziar and Trelegy, Single inhaler triple therapy (SITT), in asthma (2)
Region	Japan

Condition
Condition	asthma
Classification by specialty	Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	a prospective randomized crossover study of middle-dose Enerzair and Trelegy 100 in adult patients with moderate asthma. We will compare the efficacy and adverse events of each medications.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL scores and forced expiratory volume in 1 second. Background factors of medication selected as better.
Key secondary outcomes	Various pulmonary function test items, FeNO levels, and frequency of adverse events.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
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	Enerzair
Interventions/Control_2	Trelegy
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult asthma patients aged 18 years or older with moderate asthma
Key exclusion criteria	1) Patients who have difficulty inhaling by themself 2) Patients who are unable to perform lung function tests 3) For example, patients with end-stage cancer, severe heart failure, liver cirrhosis, respiratory failure, etc. 4) Current smokers, pregnant women, under 17 years old
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Muraki
Organization	Kindai University Nara Hospital
Division name	Department of Respiratory Medicine and Allergology
Zip code	630-0293
Address	1248-1 Otoda-cho, Ikoma, Nara 630-0293, Japan
TEL	0743-77-0880
Email	muraki-m@med.kindai.ac.jp

Public contact
Name of contact person	1st name Masato Middle name Last name Muraki
Organization	Kindai University Nara Hospital
Division name	Department of Respiratory Medicine and Allergology
Zip code	630-0293
Address	1248-1 Otoda-cho, Ikoma, Nara 630-0293, Japan
TEL	0743-77-0880
Homepage URL
Email	muraki-m@med.kindai.ac.jp

Sponsor
Institute	Kindai University
Institute
Department

Funding Source
Organization	Kindai University
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	Kindai University Nara Hospital
Address	1248-1 Otoda-cho, Ikoma, Nara 630-0293, Japan
Tel	0743-77-0880
Email	muraki-m@med.kindai.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

Other administrative information
Date of disclosure of the study information	2022 Year 07 Month 09 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	Open public recruiting
Date of protocol fixation	2022 Year 05 Month 17 Day
Date of IRB	2022 Year 06 Month 20 Day
Anticipated trial start date	2022 Year 06 Month 20 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 07 Month 09 Day
Last modified on	2022 Year 07 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055079