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

NCT03152669 | Recruiting

• 1 other identifier: 207531
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

asthma; Chronic obstructive pulmonary disease; Salford Lung Study

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who were randomised for treatment in the original SLS studies

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Manchester, M274AF, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 40158113 DERIVED

• 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.

  PMID: 34357561 DERIVED

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 15, 2017
• Study Start: April 15, 2018
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)