Last updated: 06/11/2025 13:01:28
Assessment of adherence to Single-Inhaler versus Multiple-inhaler triple therapy in asthma
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 Adherence and Persistence to Single-Inhaler versus Multiple-Inhaler Triple Therapy among Patients with Asthma
Trial description: Asthma is a chronic respiratory disease characterized by episodic and variably reversible airflow limitation and it also represents a significant cause of morbidity both in the United States (US) and globally, with substantial economic impact. Suboptimal adherence to asthma medications has been associated with poor asthma outcomes, including increased exacerbation risk, healthcare resource utilization (HRU) and costs. Studies have reported higher adherence among asthma subjects using less complex regimens, including single rather than multiple inhalers, and once-daily compared to twice-daily dosing regimens. Medication adherence and persistence are of particular importance in the management of asthma subjects requiring triple therapy. TRELEGY® is a fixed-dose combination of fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI; 100/62.5/25 micrograms [mcg]) in a single, dry-powder ELLIPTA® inhaler, which has been approved for the once-daily, maintenance treatment of chronic obstructive pulmonary disease (COPD). Single-inhaler triple therapy introduces a novel treatment paradigm for the management of subjects who remain symptomatic on dual therapy; however, real-world information on medication adherence among such subjects is currently unknown. The main objective of this observational study is to evaluate adherence and persistence to triple therapy with single-inhaler fixed-dose FF/UMEC/VI compared to Multiple-Inhaler triple therapy (MITT) among adult subjects diagnosed with asthma. This study will focus on the early trends of adherence and persistence by evaluating outcomes up to 12 months among subjects with at least 3 months (and at least 6 months as a subgroup analysis) of continuous health insurance coverage following treatment initiation. TRELEGY and ELLIPTA are registered trademarks of GlaxoSmithKline (GSK) group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean proportion of days covered (PDC)
Timeframe: Up to 12 months
Secondary outcomes:
Percentage of subjects achieving threshold of PDC more than or equal to (>=)0.8
Timeframe: Up to 12 months
Percentage of subjects achieving threshold of PDC >=0.5
Timeframe: Up to 12 months
Time to index treatment discontinuation
Timeframe: Up to 12 months
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-30-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Busse W, Abbott C, Germain G, Laliberté F, MacKnight S, Jung Y, Duh MS, Averell C. Adherence and Persistence to Single-inhaler Versus Multiple-inhaler Triple Therapy for Asthma Management. J Allergy Clin Immunol Pract.
DOI: 10.1016/j.jaip.2022.06.010
PMID: 35752431
Medical condition
Asthma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2020 to November 2020
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Inclusion criteria:
- >=1 pharmacy claim for single-inhaler fixed-dose FF/UMEC/VI (100/62.5/25 mcg), or >=1 overlapping days of supply with all three MITT asthma controller medications (ICS/LAMA/LABA) during the subject identification period (18-September-2017 to 30-September-2019).
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- >=1 pharmacy claim for single-inhaler fixed-dose FF/UMEC/VI (100/62.5/25 mcg), or >=1 overlapping days of supply with all three MITT asthma controller medications (ICS/LAMA/LABA) during the subject identification period (18-September-2017 to 30-September-2019). (a) To ensure that subjects will be identified when all therapies of (FF/UMEC/VI and MITT) were available, the date of the first pharmacy claim for FF/UMEC/VI or the date of the first occurrence of MITT (the first date of overlap in days of supply of all three triple therapy components will be defined as the index date of MITT) on or after 18-September-2017 (approval date of FF/UMEC/VI) will be termed the index date and the index therapy. (b) To maximize the sample size of FF/UMEC/VI users, the first dispensing of FF/UMEC/VI during the subject identification period will be termed as the index date. If subjects have no pharmacy claims for a single-inhaler fixed-dose FF/UMEC/VI, the date of initiation of the last component of MITT will be termed as the index date.
- >=12 months of continuous health insurance coverage prior to the index date. The 12 months prior to the index date will be defined as the Baseline period.
- >=3 months of continuous health insurance coverage after the index date (follow-up period).
- >=1 diagnosis of asthma during the Baseline period or on the index date.
- Subjects >=18 years of age at the index date. Exclusion criteria:
- Dispensing for single-inhaler fixed-dose FF/UMEC/VI and MITT (>=1 overlapping days of supply with all three MITT asthma controller medications [ICS/LAMA/LABA]) on the index date.
- >=1 diagnosis of COPD during the Baseline period or on the index date.
- >=1 least one diagnosis of cystic fibrosis during the Baseline or follow-up periods.
- At least one diagnosis of acute respiratory failure during the Baseline period or on the index date.
- >=1 dispensing for MITT (>=1 overlapping days of supply with all three asthma controller medications [ICS/LAMA/LABA]) during the Baseline period. (a) The study will focus on subjects newly initiated on triple therapy in order to minimize any confounding effects of prior treatment with MITT. (b) If the sample sizes of the FF/UMEC/VI or MITT cohorts are deemed too low after excluding subjects with prior use of MITT, a sensitivity analysis including subjects with prior use of MITT during the Baseline period will be conducted.
- FF/UMEC/VI cohort only: >=1 dispensing for single-inhaler fixed-dose FF/UMEC/VI during the Baseline period (a) While the identification period starts at the approval date of FF/UMEC/VI, this criterion ensures that only new users will be identified. By definition, subjects in the MITT cohort will have no prior FF/UMEC/VI since the first FF/UMEC/VI dispensing will be used as the index date and FF/UMEC/VI will be prioritized over MITT.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
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
2020-30-11
Actual study completion date
2020-30-11
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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