Last updated: 02/26/2024 05:50:57

Study to Assess Pre/Post Outcomes in Participants with COPD- who Move from ICS-LABA to Trelegy

GSK study ID
217414
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Pre/Post Outcomes: COPD Patients who Move from ICS-LABA to Trelegy
Trial description: The purpose of this study is to examine the impact of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) initiation on Chronic Obstructive Pulmonary Disease (COPD) exacerbations and all-cause and COPD related Health Care Resource Utilization (HCRU) experienced by participants with COPD utilizing Inhaled Corticosteroids (ICS)-Long-acting β2-agonist (LABA) prior to initiation of therapy; both overall and among a subgroup of patients who utilized Symbicort (budesonide/formoterol; BUD/FORM) during baseline. The analysis will be carried in both overall and among a subgroup of participants who utilized Symbicort (budesonide/formoterol; BUD/FORM) during baseline. This study includes commercial, and Medicare Advantage with Part D (MAPD) health plan members diagnosed with COPD who initiated FF/UMEC/VI treatment between 01 September 2017 and 31 March 2020 (study period). The index date is the date of the first pharmacy claim for FF/UMEC/VI during study period. Baseline period is defined as 12 months prior to and the index date (01 September 2017 and 31 March 2019).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Percentage of participants with COPD exacerbations before and after initiation of FF/UMEC/VI

Timeframe: Up to 24 months

Rate of COPD exacerbations among participants before and after initiation of FF/UMEC/VI

Timeframe: Up to 24 months

Percentage of all-cause and COPD-related HCRU among participants before and after initiation of FF/UMEC/VI

Timeframe: Up to 24 months

Secondary outcomes:

Percentage of participants with COPD exacerbations among participants with at least 1 episode of exacerbation during baseline period

Timeframe: Up to 12 months after Index date

Rate of COPD exacerbations among participants with at least 1 episode of exacerbation during the baseline period

Timeframe: Up to 12 months after Index date

Percentage of all-cause and COPD-related HCRU among participants with at least 1 episode of exacerbation during the baseline period

Timeframe: Up to 12 months after Index date

Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2023-01-02
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
DiRocco K, Gronroos N, Igboekwe E, Johnson M, Lee L, McCormack M, et al. . Outcomes of Patients with COPD Treated with ICS/LABA Before and After Initiation of Single-Inhaler Triple Therapy with Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI). Adv Ther. DOI: 10.1007/s12325-023-02776-8 PMID: 38310193
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
vilanterol
Collaborators
Not applicable
Study date(s)
December 2022 to February 2023
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
35+ years
Accepts healthy volunteers
No
  • At least 1 pharmacy claim for FF/UMEC/VI during the participant identification period of 01 September 2017 through 31 March 2019. The index date will be the date of the first pharmacy claim for FF/UMEC/VI.
  • At least 2 medical claims with a diagnosis code for COPD in any position on separate dates of service during the 12-month period prior to and including the index date (Baseline period)
  • At least 1 medical claim with a diagnosis code for cystic fibrosis, interstitial lung disease, alpha-1 antitrypsin deficiency, or lung cancer during the baseline.
  • At least 2 medical claims with a diagnosis code for asthma in any position on separate dates of service during baseline (asthma and COPD (ACO) overlap).
Inclusion and exclusion criteria
Inclusion criteria:
  • At least 1 pharmacy claim for FF/UMEC/VI during the participant identification period of 01 September 2017 through 31 March 2019. The index date will be the date of the first pharmacy claim for FF/UMEC/VI.
  • At least 2 medical claims with a diagnosis code for COPD in any position on separate dates of service during the 12-month period prior to and including the index date (Baseline period)
  • Must have greater than or equal to (≥) 30 consecutive day’s supply of ICS and LABA during the twelve months prior to the index date (Baseline period).
  • At least 35 years of age as of the first day of the index year.
  • Continuous enrollment with medical and pharmacy coverage for twelve months prior to the index date (baseline period).
  • Continuous enrollment with medical and pharmacy coverage for twelve months following the index date (follow-up period).
Exclusion criteria:
  • At least 1 medical claim with a diagnosis code for cystic fibrosis, interstitial lung disease, alpha-1 antitrypsin deficiency, or lung cancer during the baseline.
  • At least 2 medical claims with a diagnosis code for asthma in any position on separate dates of service during baseline (asthma and COPD (ACO) overlap).
  • At least 1 pharmacy claim for FF/UMEC/VI during the baseline period.
  • Triple therapy during Baseline (excluding index date), defined as >= 30 consecutive days of overlap in the day’s supply of ICS, LABA, Long-Acting Muscarinic Antagonist (LAMA).
  • Unknown age, gender, geographic region, or business line.
  • At least 1 fill for asthma biologic therapy (omalizumab, mepolizumab, reslizumab, benralizumab, tezepelumab, or dupilumab) during baseline.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2023-01-02
Actual study completion date
2023-01-02

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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