Last updated: 03/05/2025 05:20:09
Oral corticosteroid use in participants with asthma treated with TRELEGY Ellipta®
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Real-World Impact of Single Inhaler Triple Therapy
on Oral Corticosteroid Use among Patients with Asthma in the US
Trial description: This study aims to evaluate OCS use, asthma-related exacerbations, and short-acting beta-2 agonist (SABA) use, in the 12 months following initiation of TRELEGY Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol [FF/UMEC/VI]) relative to the 12 months prior among participants diagnosed with asthma.TRELEGY Ellipta is a registered trademark of GlaxoSmithKline group of companies.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean number of OCS dispensings
Timeframe: Up to 2 years
Secondary outcomes:
Percentage of participants with greater than or equal to (>=)1 OCS dispensing
Timeframe: Up to 2 years
Number of participants with chronic OCS use
Timeframe: Up to 2 years
Mean number of OCS bursts
Timeframe: Up to 2 years
Number of participants with average daily dose per dispensing
Timeframe: Up to 2 years
Percentage of participants by degree of OCS exposure (prednisone equivalent)
Timeframe: Up to 2 years
Number of participants with overall (inpatient/Emergency Depatment-defined and Systemic Corticosteroid [SCS]-defined) asthma exacerbations
Timeframe: Up to 2 years
Number of asthma exacerbation episode per participant
Timeframe: Up to 2 years
Percentage of participants using >=1 SABA canister
Timeframe: Up to 2 years
Mean number of SABA canisters used per participant
Timeframe: Up to 2 years
Mean duration of treatment
Timeframe: Up to 2 years
Mean days of supply per dispensing
Timeframe: Up to 2 years
Percentage of participants stratified by latest controller medication used prior to FF/UMEC/VI initiation
Timeframe: Up to 2 years
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-08-07
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol/umeclidinium bromide, umeclidinium bromide, vilanterol
Collaborators
Not applicable
Study date(s)
November 2021 to July 2022
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 Years - NA
Accepts healthy volunteers
Not applicable
- Inclusion Criteria
- Participants with >=1 dispensing of single-inhaler FF/UMEC/VI 100/62.5/25 micrograms (mcg) or 200/62.5/25 mcg, the first dispensing between 18-Sep-2017 (approval date of FF/UMEC/VI) and 31-Mar-2019 will be defined as the index date.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria
- Participants with >=1 dispensing of single-inhaler FF/UMEC/VI 100/62.5/25 micrograms (mcg) or 200/62.5/25 mcg, the first dispensing between 18-Sep-2017 (approval date of FF/UMEC/VI) and 31-Mar-2019 will be defined as the index date.
- Participants with >=12 months of continuous eligibility prior to the index date (defined as the pre-treatment period).
- Participants with >=12 months of continuous eligibility after the index date (defined as the post-treatment period).
- Participants with >=1 medical claim with a diagnosis of asthma (International Classification of Diseases [ICD] 10th Revision, Clinical Modification [10-CM] code: J45.xxx) in the primary or secondary position during the pre-treatment period or on the index date.
- Participants >=18 years of age at the index date. Exclusion Criteria:
- Participants with >=1 medical claim with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) ICD-10-CM: J41.x–J44.x in any position during the pre-treatment period or on the index date.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
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
2022-08-07
Actual study completion date
2022-08-07
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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