The Extended Salford Lung Study ("Ex-SLS") Data Access Project

Asthma Clinical Trial

Official title:

The Extended Salford Lung Study ("Ex-SLS") Data Access Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03152669
• Other study ID #: 207531
• Status: Recruiting
• Start date: April 15, 2018
• Est. completion date: April 30, 2028

Study information

• Verified date: September 2022
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: April 30, 2028
• Est. primary completion date: April 30, 2028
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective EMR data	All historical data from consent until the beginning of patients' electronic health records, encompassing all routinely-available electronic demographic and health-related data back to a patients' earliest available electronic record.	Up to 10 years
Primary	Prospective EMR data	Prospective longitudinal data, encompassing collection of future routinely-recorded electronic demographic and health-related data for a period of ten years from this consent or until a patient is either lost to follow up or at the time of their death.	Up to 10 years
Primary	Risk factor questionnaire	Historical demographic, COPD/asthma risk factor information and clinical data not routinely available. Collected via paper questionnaire.	Up to 10 years