NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1030210229

Registered date:01/09/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedCOPD
Date of first enrollment01/09/2021
Target sample size3500
Countries of recruitment
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeAge 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

Key inclusion & exclusion criteria

Age minimum>= 40age old
Age maximumNot applicable
GenderBoth
Include criteria1. 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.
Exclude criteria1.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

Related Information

Contact

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