UMIN-CTR Clinical Trial

Basic information
Public title	A QOL Value Survey for Quality-Adjusted Life Year (QALY) Estimation for MAC Pulmonary Disease (MAC-PD)
Acronym	A QOL Value Survey for Quality-Adjusted Life Year (QALY) Estimation for MAC Pulmonary Disease (MAC-PD)
Scientific Title	A QOL-Value Survey for Quality-Adjusted Life-Year (QALY) Estimation for Pulmonary Mycobacterium avium complex Pulmonary Disease (MAC-PD).
Scientific Title:Acronym	A QOL Value Survey for QALY Estimation for MAC-PD
Region	Japan

Condition
Condition	Non-tuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC)
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the effect of increasing or decreasing the severity of MAC pulmonary disease (MAC-PD) and the symptoms associated with negative sputum cultures and the burden on daily life on the QOL value for the relevant health condition based on the responses obtained from a questionnaire survey of the general population, and to quantify the health economics value of each condition.
Basic objectives2	Others
Basic objectives -Others	QOL survey
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL values by severity in patients with MAC-PD.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) General adults aged 20 years or older at screening (2) Individuals who are judged by the investigator to have adequate understanding of the conduct of the study (3) Those who agreed to participate in the study. (4) Persons who can complete the protocol-specified procedures (5) Individuals living in Japan at the time of screening
Key exclusion criteria	(1) Patients who have difficulty obtaining informed consent and conducting this study due to lack of Japanese language ability (2) Individuals who cannot participate in the survey
Target sample size	319

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Sakamoto
Organization	Insmed GK
Division name	Research and Development and Medical Affairs
Zip code	100-0014
Address	1-10-3 Nagata-cho, Chiyoda-ku, Tokyu capitol Tower 13F
TEL	03-4232-2191
Email	hideki.sakamoto@Insmed.com

Public contact
Name of contact person	1st name Tatsunori Middle name Last name Murata
Organization	CRECON Medical Assessment Inc.
Division name	NA
Zip code	150-0002
Address	The Pharmaceutical Society of Japan, Nagai Memorial 12-15, Shibuya 2-chome, Shibuya-ku, Tokyo
TEL	03-3407-4491
Homepage URL
Email	Tatsunori.murata@crecon.jp

Sponsor
Institute	Insmed GK
Institute
Department

Funding Source
Organization	Insmed GK
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	Non-Profit Organization, MINS Research Ethics Committee
Address	20-9-401, 5-chome, Mita, Minato-ku, Tokyo
Tel	03-6416-1868
Email	npo-mins@j-irb.com

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 10 Month 22 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	319
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	Completed
Date of protocol fixation	2021 Year 10 Month 01 Day
Date of IRB	2021 Year 10 Month 07 Day
Anticipated trial start date	2021 Year 11 Month 26 Day
Last follow-up date	2021 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The time trade-off (TTO) method is used in this study.

Management information
Registered date	2022 Year 10 Month 20 Day
Last modified on	2022 Year 10 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056118