Last updated: 11/22/2024 04:40:39

Updated Investigation on the effects of Prompt vs Delayed in COPD patients

GSK study ID
219801
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: An Updated Investigation on the Effects of Prompt versus Delayed Initiation of FF/UMEC/VI on Exacerbations and Readmissions among Patients with Chronic Obstructive Pulmonary Disease in a Commercially Insured US Population
Trial description: This study is an Updated Investigation on the Effects of Prompt versus Delayed Initiation of Prompt versus Delayed Initiation of FF/UMEC/VI on Exacerbations and Readmissions among Patients with Chronic Obstructive Pulmonary Disease in a Commercially Insured US Population. . A retrospective weighted or matched cohort design will be used with medical and pharmacy claims data, including enrolment information, from the IQVIA PharMetrics® Plus database. The IQVIA PharMetrics® Plus database offers a diverse representation of employers, payers, and providers, with geographic zones covering all 50 states of the US. It contains around 40 million patients with both medical and pharmacy benefits in any given recent year, with an average length of health plan enrolment of approximately 39 months. The enrollee population in the IQVIA PharMetrics Plus database is generally representative of the less-than-65-years-of-age, commercially insured population in the US with respect to both age and gender. The population over 65 years of age consists of enrollees in managed care plans for seniors, working elderly, and others in commercial plans. The database includes historical information on patient demographics, plan enrollment, and inpatient, outpatient, and pharmacy claims. Data are de-identified and compliant with the Health Insurance Portability and Accountability Act (HIPAA). . Preliminary counts of patients diagnosed with COPD and treated with FF/UMEC/VI therapy are for the period from September 18, 2017 to June 30, 2022.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Rate of overall, moderate, and severe episodes of COPD related exacerbations

Timeframe: Up to 5 years

Secondary outcomes:

Time-to-first COPD-related overall, moderate, and severe exacerbation

Timeframe: At 3, 6, 9, and 12 months after the index date

All-cause and COPD-related healthcare costs

Timeframe: Up to 5 years

Rate of hospital readmission related to all-cause and COPD

Timeframe: At 30, 60, and 90 days after the index date

Time-to-first hospital readmission related to all-cause and COPD

Timeframe: At 30, 60, and 90 days after the index date

Clinical characteristics among prompt and delayed initiators

Timeframe: Up to 5 years

Association between time-to-initiation of FF/UMEC/VI and rate of COPD-related exacerbations (including overall, moderate, and severe episodes)

Timeframe: Up to 5 years

Association between time-to-initiation of FF/UMEC/VI and time-to-first COPD-related exacerbation (including overall, moderate, and severe episodes)

Timeframe: Up to 5 years

Association between time-to-initiation of FF/UMEC/VI and all-cause and COPD-related healthcare costs

Timeframe: Up to 5 years

Association between time-to-initiation of FF/UMEC/VI and rate and time-to-first all-cause and COPD-related hospital readmission (i.e., 30-day, 60-day, and 90-day rates) following a COPD-related hospitalization

Timeframe: At 30, 60, and 90 days after the index date

Rate of overall, moderate and severe COPD-related exacerbations of prompt versus delayed initiators of FF/UMEC/VI following a moderate or severe COPD-related exacerbation in patients with and without prior COPD-related exacerbation.

Timeframe: Up to 5 years

Rate of overall, moderate and severe COPD-related exacerbations of prompt versus delayed initiators of FF/UMEC/VI following a moderate or severe COPD-related exacerbation in patients without prior use of triple therapy.

Timeframe: Up to 5 years

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2024-10-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Paczkowski R, Noorduyn S, DiRocco K, Germain G, Laliberte F, Urosevic A, et al. . FF/UMEC/VI Initiation Following a COPD Exacerbation: Benefits of Prompt Initiation on COPD Outcomes. Adv Ther. PMID: 39453592 DOI: 10.1007/s12325-024-02999-3
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2023 to January 2024
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
  • At least one COPD-related moderate or severe exacerbation on or after September 18, 2017
  • At least 12 months of continuous health insurance coverage prior to the index date
  • At least 1 COPD-related exacerbation (moderate or severe) during the baseline period and prior to the index exacerbation episode
  • At least 1 pharmacy claim for single-inhaler FF/UMEC/VI prior to the index date
Inclusion and exclusion criteria
Inclusion criteria:
  • At least one COPD-related moderate or severe exacerbation on or after September 18, 2017
  • At least 12 months of continuous health insurance coverage prior to the index date
  • At least 6 months of continuous health insurance coverage after the index date
  • At least 1 pharmacy claim for single-inhaler FF/UMEC/VI within 6 months after the index date
  • Severe COPD-related exacerbation on the index date (Only for Hospital readmissions analysis)
Exclusion criteria:
  • At least 1 COPD-related exacerbation (moderate or severe) during the baseline period and prior to the index exacerbation episode
  • At least 1 pharmacy claim for single-inhaler FF/UMEC/VI prior to the index date

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
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
2024-10-01
Actual study completion date
2024-10-01

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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