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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma

• Study Type: Observational
• Enrollment (Estimated): 3500

Contacts and Locations

• Study Contact: Name: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
• Study Contact Backup: Name: EU GSK Clinical Trials Call Center; Phone Number: +44 (0) 20 89904466; Email: GSKClinicalSupportHD@gsk.com

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M274AF
    • Recruiting
    • GSK Investigational Site
    • Contact: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718
    • Contact: EU GSK Clinical Trials Call Center; Phone Number: +44 (0) 20 8990 4466

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects who were randomised for treatment in the original SLS studies

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Chronic obstructive pulmonary disease; Subjects with COPD who were randomised to treatment in the original SLS
Asthma; Subjects with asthma who were randomised to treatment in the original SLS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Risk factor questionnaire	Historical demographic, COPD/asthma risk factor information and clinical data not routinely available. Collected via paper questionnaire.	Up to 10 years

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

General Publications

• Meeraus W, Fry M, Yeatman R, Pimenta JM, Astrom J, Barth A, McCorkindale S, Jones R, Leather D. Key Learnings from Running an Extension Study to a Real-World Effectiveness Trial: The Extended Salford Lung Study. Adv Ther. 2021 Sep;38(9):4847-4858. doi: 10.1007/s12325-021-01827-2. Epub 2021 Aug 6.
• Goodall E, Rothnie KJ, Numbere B, Zhang S, Compton C, Wood R, Tritton T, Wild R, Small M, Vestbo J, Woodcock A. Describing the burden of moderate exacerbations in patients with asthma from the Extended Salford Lung Study (Ext-SLS): a retrospective cohort study. Respir Res. 2025 Mar 29;26(1):121. doi: 10.1186/s12931-025-03199-5.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: asthma; Chronic obstructive pulmonary disease; Salford Lung Study
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Asthma
• Other Study ID Numbers: 207531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No