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Clinical Trials/JPRN-jRCT1030210229
JPRN-jRCT1030210229
Recruiting
未知

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

Akiyama Shoko0 sites3,500 target enrollmentSeptember 1, 2021
ConditionsCOPD

Overview

Phase
未知
Intervention
Not specified
Conditions
COPD
Sponsor
Akiyama Shoko
Enrollment
3500
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 1, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Akiyama Shoko

Eligibility 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.

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

Outcomes

Primary Outcomes

Not specified

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