Last updated: 03/11/2025 05:01:32

SLR and NMA to compare the impact of SERETIDE® vs. relevant comparators on HRQoL

GSK study ID
217675
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Systematic literature review (SLR) and network meta-analysis (NMA) to compare the impact of SERETIDE vs. relevant comparators on health-related quality of life (HRQoL)
Trial description: This study aims to understand the relative efficacy of fixed-dose, fluticasone propionate/salmeterol (Flu/Sal) versus other fixed-dose, inhaled corticosteroid (ICS)/long-acting beta agonist (LABA) regimens, and beclometasone/formoterol (Beclo/Form) maintenance and reliever therapy (MART)/budesonide/formoterol MART in adults and adolescents with moderate or moderate-to-severe asthma in terms of health related quality of life (HRQoL).
SERETIDE is a registered trademark of GlaxoSmithKline group of companies.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Mean change from Baseline in HRQoL by Asthma Quality of Life Questionnaire (AQLQ)

Timeframe: Baseline and up to 52 weeks

Mean change from Baseline in HRQoL by AQLQ standardized version (S)

Timeframe: Baseline and up to 52 weeks

Secondary outcomes:

Mean change from Baseline in asthma control by asthma control questionnaire (ACQ)-5

Timeframe: Baseline and up to 52 weeks

Mean change from Baseline in asthma control by ACQ-6

Timeframe: Baseline and up to 52 weeks

Mean Baseline asthma control by ACQ-5

Timeframe: Baseline

Mean Baseline asthma control by ACQ-6

Timeframe: Baseline

Number of participants with AQLQ data stratified by asthma control

Timeframe: Up to 52 weeks

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-22-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Kittipong Maneechotesuwan, Dave Singh, Leandro G Fritscher, Nese Dursunoglu, Abhijit PG, Abhay Phansalkar, Bhumika Aggarwal, Emilio Pizzichini, Justyna Chorazy, Heather Burnett. Impact of inhaled fluticasone propionate/salmeterol on health-related quality of life in asthma: a network meta-analysis.Respir Med.2022; DOI: 10.1016/j.rmed.2022.106993
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Evidera
Study date(s)
April 2022 to April 2022
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • Inclusion Criteria:
  • Population:
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion Criteria:

    • Population:

    • Adults (greater than or equal to [>=]18 years) and adolescents (>=12 to less than [<]18 years)
    • Participants with moderate-to-severe asthma inadequately controlled with as needed low-medium dose ICS (+ LABA or any other controller)
    • Key subgroups of interest: Results by level of asthma control at Baseline

    Intervention:

    • Fixed-dose, twice daily Flu/Sal maintenance therapy + minus (-) short-acting beta-adrenoceptor agonist (SABA) reliever
    • Budesonide/formoterol MART
    • Beclomethasone/formoterol MART
    • Other fixed-dose, twice daily ICS/LABA combinations +- SABA reliever

    Comparator:

    • Any of the above interventions
    • ICS monotherapy/standard of care

    Study design:

    • Randomized controlled trials (RCTs) (including comparative extension studies)
    • Comparative observational studies with appropriate adjustment (for example [e.g.], propensity score matching or multivariate analysis) for confounding factors and possible effect modifiers (e.g., age, smoking status, forced expiratory volume (FEV1), exacerbation history)
    • Pooled RCTs analyses
  • Time period: Studies from 1-Jan-2001 to present will be included.
  • Studies published in English language. Exclusion criteria:

    • Population:

    • Children <12 years
    • Participants with mild or mild-to-moderate asthma
    • Participants on long-acting muscarinic antagonist (LAMA), high-dose ICS-LABA, or biologic treatments
    • Participants with OCS-dependent asthma
    • Studies with LABA as exclusion criteria
  • Intervention: Intervention other than those listed
  • Comparator: Intervention other than those listed

    • Study design:

    • Uncontrolled observational studies (during design or analysis)
    • Single-arm trials
    • Narrative reviews
    • Letters, editorials, comments, guidelines, erratum
    • In vitro, ex vivo studies
    • Pharmacodynamic/pharmacokinetic studies
    • Genetic studies
    • Case reports or case series
    • Protocols for RCTs or for other primary study types
    • Systematic literature review (SLR)/network meta-analysis (NMA)
  • Time period: Studies published before 2001 will be excluded.
  • Studies published in languages other than English.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2022-22-04
Actual study completion date
2022-22-04

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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