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.
Investigators
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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