Last updated: 05/05/2023 12:20:15

Moderate asthma exacerbations among participants in the Extended Salford Lung Study (Ex-SLS)

GSK study ID
214485
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: Burden of moderate exacerbations in asthma patients participating in the Ex-SLS
Trial description: This study will assess the frequency and burden of moderate asthma exacerbations among participants in the United Kingdom (UK) who participated in the Ex-SLS and described across treatment and disease state subgroups. The index date will be defined as the date on which each patient consented to inclusion in the Ex-SLS (between April 2018 and May 2019, i.e. indexing period).
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of self-reported moderate asthma exacerbations

Timeframe: Up to 12 months

Secondary outcomes:

Summary of socio-demographic, clinical and asthma-related characteristics by frequency of self-reported moderate asthma exacerbations in overall participants

Timeframe: Up to 12 months

Summary of socio-demographic, clinical and asthma-related characteristics by frequency of self-reported moderate asthma exacerbations in participants using ICS-LABA maintenance therapy

Timeframe: Up to 12 months

Asthma Control Test (ACT) score at indicated time point

Timeframe: At index date

Asthma Control Questionnaire – 6-item (ACQ-6) score at indicated time point

Timeframe: At index date

Asthma Sleep Impact Scale (CASIS) at indicated time point

Timeframe: At index date

Number of participants with changes in dose or frequency of maintenance therapy

Timeframe: Up to 6 months

Number of participants with maximum dose of inhaled corticosteroids (ICS) prescribed

Timeframe: Up to 6 months

All-cause and asthma-related healthcare resource utilization (HCRU) (primary and secondary care) in overall participants

Timeframe: Up to 12 months

All-cause and asthma-related healthcare resource utilization (HCRU) (primary and secondary care) in participants using ICS-LABA

Timeframe: Up to 12 months

Number of severe asthma exacerbations

Timeframe: Up to 12 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-05-05
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)
May 2021 to May 2022
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participants must have questionnaire data and valid primary care Electronic medical record (EMR) data
  • Participants must have provided a valid response to both M5 and M6 of the asthma management section of the questionnaire.
  • None
Inclusion and exclusion criteria
Inclusion criteria:
  • Participants must have questionnaire data and valid primary care Electronic medical record (EMR) data
  • Participants must have provided a valid response to both M5 and M6 of the asthma management section of the questionnaire.
  • Participants must have both a valid Asthma Control Test (ACT) and a valid Asthma Control Questionnaire – 6-item (ACQ-6) score as collected/ calculated via the Ex-SLS questionnaire.
Exclusion criteria:
  • None

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
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
2022-05-05
Actual study completion date
2022-05-05

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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