Last updated: 08/06/2025 06:30:08

Meta-Analysis of Triple Therapy in participants with Uncontrolled Asthma

GSK study ID
215172
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evidence Synthesis to Assess Comparative Efficacy and Safety of Triple Therapy in Patients with Uncontrolled Asthma on ICS/LABA
Trial description: This study will perform an indirect treatment comparison or network meta-analysis of the comparative efficacy of Fluticasone furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) against other triple therapy (Multiple inhaler triple therapy [MITT] and Single inhaler triple therapy [SITT]) for adult participants with asthma who are inadequately controlled by inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) therapy.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change from Baseline in trough Forced Expiratory Volume in One Second (FEV1) at 24 weeks

Timeframe: Baseline and Week 24

Annualized rate of moderate/severe exacerbations at 52 weeks

Timeframe: Week 52

Time to first moderate/severe exacerbation during study follow-up

Timeframe: Up to Week 52

Change from Baseline in Asthma Control Questionnaire (ACQ)-7 total score at 24 weeks

Timeframe: Baseline and Week 24

ACQ-7 responder rate at 24 weeks

Timeframe: Week 24

Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total score at 24 weeks

Timeframe: Baseline and Week 24

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2025-10-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
vilanterol
Collaborators
Not applicable
Study date(s)
June 2021 to November 2025
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participants with a diagnosis of asthma; Moderate to severe asthma, Severe asthma, e.g., refractory asthma or difficult-to-treat asthma, Persistent asthma.
  • Participants whose asthma is inadequately controlled despite treatment with ICS/LABA therapy. Proportion of participants receiving ICS/LABA at Baseline >=70 percent.
  • Studies only conducted in participants <18 years of age; studies where participants mean age <=17 years, Proportion of adults participants (aged 18+) is <75 percent of the total participant Population.
  • Participants with a diagnosis of chronic obstructive pulmonary disease (COPD).
Inclusion and exclusion criteria
Inclusion criteria:
  • Participants with a diagnosis of asthma; Moderate to severe asthma, Severe asthma, e.g., refractory asthma or difficult-to-treat asthma, Persistent asthma.
  • Participants whose asthma is inadequately controlled despite treatment with ICS/LABA therapy. Proportion of participants receiving ICS/LABA at Baseline >=70 percent.
  • Adults (18 years or older).
  • Studies reporting any triple therapy (ICS-LABA-Long-acting muscarinic antagonist [LAMA]) or dual (ICS-LABA) therapy as interventions will be included.
  • Studies with with dual or triple comparators will be included.
  • Studies reporting following outcomes will be included; lung function, exacerbations, asthma control, quality of life, safety and resource use outcomes.
  • Randomized controlled trials will be included.
  • Studies shall be included in the evidence synthesis networks if the following criteria are further fulfilled; Studies with a relevant comparator with medium to high ICS dose and trial duration >= 8 weeks.
Exclusion criteria:
  • Studies only conducted in participants <18 years of age; studies where participants mean age <=17 years, Proportion of adults participants (aged 18+) is <75 percent of the total participant Population.
  • Participants with a diagnosis of chronic obstructive pulmonary disease (COPD).
  • Mixed Population (for e.g., Asthma and COPD) with no results for asthma participant Population.
  • Studies with following interventions will be excluded; No ICS/LAMA/LABA triple combination therapies or dual ICS/LABA therapies in the clinical trials, Mono versus dual ICS/LABA therapies, Mono versus mono therapies, Biologics and leukotriene receptor antagonists (LTRAs) are not relevant treatment arms, Single maintenance and reliever therapy (SMART) is not relevant treatment arm and ICS in combination with a LAMA is not a relevant treatment arm.
  • Studies reporting outcomes anything other than the listed ones for inclusion will be excluded.
  • Single-arm trials, Observational studies, Phase I study, Practical clinical trials, Cross-sectional studies, Follow-up studies, Longitudinal studies, Case-control studies, Prospective cohort studies, Retrospective cohort studies, Registry-based studies, Database-based studies, Clinical drug evaluations, Narrative reviews, Economic models, Case reports, Letter/ Editorial/ Commentary/ News, Historical articles and Animal studies will be excluded.
  • Any conference proceeding before 2018

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

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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