臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 01, 2021
Last modified on	Sept. 01, 2021
Trial ID	jRCT1030210229

Scientific Title	Characteristics of patients with COPD newly treated with fluticasone/umeclidinium/vilanterol, budesonide/glycopyrronium/formoterol, or multiple inhaler triple therapy in the Medical Data Vision, Inc. clinical database
Public Title	Characteristics of patients with COPD newly treated with fluticasone/umeclidinium/vilanterol, budesonide/glycopyrronium/formoterol, or multiple inhaler triple therapy in the Medical Data Vision, Inc. clinical database

Contact for Scientific Queries	Name	Akiyama Shoko
	Affiliation	GlaxoSmithKline K.K.
	Address	Akasaka Intercity AIR 1-8-1, Akasaka, Minato-ku, Tokyo, 107-0052, Japan
	Telephone	+81-3-4231-5000
	E-mail	shoko.2.akiyama@gsk.com
Contact for Public Queries	Name	Akiyama Shoko
	Affiliation	GlaxoSmithKline K.K.
	Address	Akasaka Intercity AIR 1-8-1, Akasaka, Minato-ku, Tokyo, 107-0052, Japan
	Telephone	+81-3-4231-5000
	E-mail	shoko.2.akiyama@gsk.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 01, 2021
Actual date of first enrollment
Target sample size		3500
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. At least one pharmacy prescription claim(s) for Trelegy, Breztri Aerosphere, or a MITT between 1 September 2019 and most recent data available at the time of the study. The index date will be earliest initiation of treatment. Specifically: a. Date of first prescription for Trelegy b. Date of first prescription for Breztri Aerosphere c. Any of the following scenarios for MITT, occurring no earlier than the start of the study period: i. Prescription date of the last monotherapy component (ICS, LAMA, or LABA) overlapping with both of two preceding monotherapies (ICS, LAMA, or LABA) ii. Prescription date of last monotherapy component (LAMA or ICS) overlapping with preceding dual therapy (ICS/LABA or LAMA/LABA, respectively) iii. Prescription date of the last dual therapy component (ICS/LABA or LAMA/LABA) added to preceding monotherapy (LAMA or ICS, respectively) 2. Age >=40 at index date 3. >=2 outpatient or >=1 hospitalization record with an International Classification of Diseases, 10th Revision (ICD-10) diagnosis code for COPD (J42, J43 or J44) in the 12 calendar months prior and including the index calendar month. 4. >=1 outpatient or hospitalization record with any ICD-10 diagnosis code in the 6-month period prior to the 12-month lookback period. 5. New users as of the index date. Defined as follows (not mutually exclusive): a) No record of Trelegy in the 12-month lookback period (Objective 1a) b) No record of triple therapy (Trelegy, Breztri Aerosphere, or MITT) in the 12-month lookback period (Objective 1b). c) No record of any maintenance therapy (ICS, LABA, or LAMA-containing therapies) in the 12-month lookback period (Objective 2) For Objectives 1b and 2, patients will be assigned to their respective study cohorts based on whether the index prescription record was for Trelegy, Breztri Aerosphere, or MITT.
	Exclusion Criteria	1. For the analysis under primary objective b, patients will be excluded if they used inhaled triple therapy (Trelegy, Breztri Aerosphere, or open inhaled triple treatment) in the 12-month lookback period 2. For the analysis under secondary objective, patients will be excluded if they used any maintenance therapy (ICS, LABA, or LAMA containing medications) in the 12-month lookback period
	Age Minimum	40age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		COPD
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Age at Index date, Calendar year of index date, Quarter of index date, Gender, Treatment history, BMI, Smoking status, Presence of Lung function test, Quan Charlson Comorbidity Index, Comorbidities, History of COPD exacerbations requiring hospitalization, History of COPD exacerbations not requiring hospitalization
Secondary Outcome(s)

Primary Sponsor	GlaxoSmithKline K.K.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Kitamachi Clinic
Address	1-1-3 Kitamachi, Musashino-city, Tokyo, Tokyo
Telephone	+81-70-5011-8550
E-Mail	shingo-namiki@cmicgroup.com
Approval Status	Approval
Date of approval	July. 21, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none