Last updated: 05/12/2025 14:10:16
Historical cohort study of asthma control and exacerbations outcomes in FP/SAL versus BUD/FOR FDC in United States population
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Comparative effectiveness of fluticasone propionate/salmeterol (FP/SAL - Seretide/Advair) and budesonide/formoterol fumarate dihydrate (BUD/FOR -Symbicort) fixed dose combinations (FDC) of Inhaled corticosteroid/long-acting β-agonist (ICS/LABA) in moderate to severe asthma patients: A US Population Retrospective Database Analysis
Trial description: This study will assess the comparative effectiveness for FP/SAL compared to BUD/FOR in moderate to severe asthma participants, with a focus on asthma control and exacerbation outcomes. The index date will be earliest date (within the participant identification period) with evidence of pharmacy claims on Inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) prescription.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with asthma control test (ACT) score
Timeframe: Baseline (12 months before the index date including the index date) and up to follow up (12 months from the index date)
Change in ACT score
Timeframe: Baseline (12 months before the index date including the index date) and up to follow up (12 months from the index date)
Ratio of asthma medication
Timeframe: Baseline (12 months before the index date including the index date) and up to follow up (12 months from the index date)
Number of Short-acting beta-agonists (SABA) fills dispensed by month
Timeframe: Baseline (12 months before the index date including the index date) and up to follow up (12 months from the index date)
Number of participants with asthma exacerbations
Timeframe: Baseline (12 months before the index date including the index date) and up to follow up (12 months from the index date)
Secondary outcomes:
Percentage of days covered (PDC)
Timeframe: Up to follow up (12 months from the index date)
Percentage of participants with discontinuation of index FDC
Timeframe: Up to follow up (12 months from the index date)
Percentage of participants switching to alternate non-index FDC (FP/SAL versus BUD/FOR)
Timeframe: Up to follow up (12 months from the index date)
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2024-29-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
February 2024 to July 2024
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- One or more pharmacy claims for either FP/SAL or BUD/FOR during the participant identification period of 01 July 20011 through 31 December 2018. The index date will be the date of the first pharmacy claim of either FP/SAL or BUD/FOR. Participants with only one pharmacy claim with no further claims in the follow-up period will be flagged, assessed, and reported in a sensitivity analysis. The different dosages of FDC ICS/LABA will be flagged.
- Participants with moderate-to-severe asthma identified using Global Initiative for Asthma (GINA) 3/4 treatment steps. Participants with mixed asthma and COPD diagnoses will be identified and the study will conduct a sensitivity analysis of inclusion/exclusion of this population.
- One or more pharmacy claims for any other fixed-dose ICS/LABA during the Baseline period, including on the index date.
- At least one medical claim with a diagnosis code for cystic fibrosis, lung cancer, interstitial lung disease, lung or bronchial developmental anomalies (such as bronchiolitis obliterans), pulmonary fibrosis (not including pulmonary hypertension), pulmonary resection, bronchiectasis, pneumonia, or alpha-1 antitrypsin deficiency during the Baseline period.
Inclusion and exclusion criteria
Inclusion criteria:
- One or more pharmacy claims for either FP/SAL or BUD/FOR during the participant identification period of 01 July 20011 through 31 December 2018. The index date will be the date of the first pharmacy claim of either FP/SAL or BUD/FOR. Participants with only one pharmacy claim with no further claims in the follow-up period will be flagged, assessed, and reported in a sensitivity analysis. The different dosages of FDC ICS/LABA will be flagged.
- Participants with moderate-to-severe asthma identified using Global Initiative for Asthma (GINA) 3/4 treatment steps. Participants with mixed asthma and COPD diagnoses will be identified and the study will conduct a sensitivity analysis of inclusion/exclusion of this population.
- At least 18 years of age as of the index date.
- Continuous enrollment with medical and pharmacy coverage for 12 months prior to and including the index date (Baseline period).
- Continuous enrollment with medical and pharmacy coverage for at least 12 months following the index date (follow-up period).
- Continuous activity with at least 12 months prior to index date, for participants with both claims and Electronic Health Record (EHR) data.
- Continuous activity with at least 12 months post index date, for participants with both claims and EHR data.
- At least one medical claim with a diagnosis code for asthma in any position during the Baseline period.
Exclusion criteria:
- One or more pharmacy claims for any other fixed-dose ICS/LABA during the Baseline period, including on the index date.
- At least one medical claim with a diagnosis code for cystic fibrosis, lung cancer, interstitial lung disease, lung or bronchial developmental anomalies (such as bronchiolitis obliterans), pulmonary fibrosis (not including pulmonary hypertension), pulmonary resection, bronchiectasis, pneumonia, or alpha-1 antitrypsin deficiency during the Baseline period.
- At least 2 medical claims with a diagnosis code for Chronic Obstructive Pulmonary Disease (COPD) in any position on separate dates of service during the Baseline period.
- Receipt of both FP/SAL and BUD/FOR on the index date.
- Participants with a pharmacy claim for biologics used for asthma treatment, including mepolizumab, reslizumab, benralizumab, omalizumab, and dupilumab, during the Baseline and follow-up periods. While biologics are indicated for severe uncontrollable asthma, these are thought to have a significantly confounding impact on the outcomes with non-biologics asthma management.
- Participants with a pharmacy claim for long-acting muscarinic antagonists (LAMA), e.g., anticholinergics, during the Baseline periods.
- Participants on multi-inhaler dual therapy or history of open dual therapy in the Baseline period will be excluded.
- Unknown age, sex, geographic region, or insurance type.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
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
2024-29-07
Actual study completion date
2024-29-07
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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