Last updated: 03/24/2025 19:30:22
The Extended Salford Lung Study (“Ex-SLS”) Data Access Project
GSK study ID
207531
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: The Extended Salford Lung Study (“Ex-SLS”) Data Access Project
Trial description: The Salford Lung Study (SLS) subjects represent a group of COPD and asthma patients whose disease is extremely well-characterised over a short time period. Subjects in the SLS originally consented for information relevant to the study to be shared with the sponsor (GSK). These data were limited to three years prior to randomisation and the twelve-month interventional treatment period. Broadened access to patients’ data would allow SLS subjects’ entire disease journey to be researched, presenting a rare opportunity to improve scientific and clinical understanding of COPD/asthma disease risk, treatment and progression. This proposal seeks to collect additional subject-level data from SLS patients via their electronic medical records (encompassing past and future data for up to 10 years from the date of consent) and via a one-off patient questionnaire administered at the time of consent.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Retrospective EMR data
Timeframe: Up to 10 years
Prospective EMR data
Timeframe: Up to 10 years
Risk factor questionnaire
Timeframe: Up to 10 years
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
3500
Primary completion date:
2028-30-04
Observational study model:
Other
Time perspective:
Other
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
April 2018 to April 2028
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
- Subjects who were randomized to treatment in the original SLS studies
- Subjects who are able to, and choose to, provide written consent for the additional information to be collected.
- Subjects who were lost to follow-up/moved away, withdrew consent or died during or subsequent to the original SLS studies.
- Subjects considered (at the discretion of the investigator) as too ill to participate or without the mental capacity to provide informed consent.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who were randomized to treatment in the original SLS studies
- Subjects who are able to, and choose to, provide written consent for the additional information to be collected.
Exclusion criteria:
- Subjects who were lost to follow-up/moved away, withdrew consent or died during or subsequent to the original SLS studies.
- Subjects considered (at the discretion of the investigator) as too ill to participate or without the mental capacity to provide informed consent.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Recruiting
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
Additional information
Not applicable
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