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

Recruiting

• Conditions: COPD

• Registration Number: jRCT1030210229
• Lead Sponsor: GlaxoSmithKline K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-01
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3500

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Age at Index date		Age of the patient at the index date
Calendar year of index date		Calendar year when the index date occurred
Quarter of index date		Quarter of the year when the index date occurred
Gender		Gender of the patient
Treatment history		History of treatments received by the patient
BMI		Body Mass Index of the patient
Smoking status		Smoking status of the patient
Presence of Lung function test		Indicates whether a lung function test was performed
Quan Charlson Comorbidity Index		Score quantifying the burden of comorbidities
History of COPD exacerbations requiring hospitalization		History of COPD exacerbations that required hospitalization
History of COPD exacerbations not requiring hospitalization		History of COPD exacerbations that did not require hospitalization
Comorbidities		Presence of other medical conditions alongside the primary condition