Last updated: 05/26/2026 15:10:44

Network 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
Ongoing
Ongoing
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

Secondary outcomes:

Change from Baseline in Asthma Control Questionnaire (ACQ)-7 Total Score at 24 Weeks

Timeframe: Baseline and Week 24

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

Interventions:
Not applicable
Enrollment:
Not applicable
Observational study model:
Cohort
Primary completion date:
2026-25-08
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
vilanterol
Collaborators
Not applicable
Study date(s)
June 2021 to August 2026
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 greater than or equal to (>=) 70 percent.
  • Studies only conducted in participants less than (<) 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 greater than or equal to (>=) 70 percent.
  • Adults (18 years or older).

    • Studies reporting any combination of ICS, long-acting muscarinic antagonist (LAMA), and LABA triple therapies in one single inhaler or multiple inhalers, e.g.,

    • Tiotropium plus (+) all ICS/LABA therapies
    • Tiotropium + fluticasone + salmeterol
    • Budesonide + glycopyrrolate + formoterol
    • Glycopyrronium + fluticasone + salmeterol
    • Fluticasone + umeclidinium + vilanterol
    • Beclometasone + formoterol + glycopyrronium
    • Umeclidinium + fluticasone + salmeterol

    Studies with any dual versus dual therapies

    • Any ICS-LABA vs. ICS-LABA dual therapies in one single inhaler or multiple inhalers

    Studies reporting asthma-related outcomes including clinical, efficacy, safety, quality of life, and resource use measures:

    • Mean change from baseline in lung function endpoints: peak Forced Expiratory Volume in 1 second (FEV1)
    • Annualized rate and number of participants with total (moderate and severe), moderate or severe asthma exacerbations, and proportion of participants by number of exacerbations (e.g. exacerbation categories of 0, 1, 2+)
    • Time to first moderate and/or severe asthma exacerbations
    • Mean change of total score from baseline in asthma control (Asthma Control Test [ACT] or Asthma Control Questionnaire [ACQ])
    • Proportion of participants achieving clinical remission. Defined as meeting all 4, or the first 3 of the following components: free from OCS use (including maintenance OCS and includes oral, intravenous and subcutaneous steroids.); no severe exacerbations (as defined in CAPTAIN); ACQ-5 total score less than or equal to (<=) 1.5; change from baseline in trough FEV1 >= 100 milliliters (mL)
  • Randomized controlled trials (RCT) will be included (Phase II, III, and IV).
  • RCT extension studies (as long as randomization has not been broken)
  • Pragmatic trials
  • Conference proceedings that report original data
  • Systematic reviews of interest will be included for reference checks
  • Other considerations will include any language, no limit to geographical location or time horizon, or studies where the trial duration was shorter than 8 weeks will be included in the systematic literature review (SLR) but not to be extracted
Exclusion criteria:
  • Studies only conducted in participants less than (<) 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)

No location data available.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Ongoing
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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