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

NCT ID: NCT03152669

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-15

Study Completion Date

2028-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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asthma Chronic obstructive pulmonary disease Salford Lung Study

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Chronic obstructive pulmonary disease

Subjects with COPD who were randomised to treatment in the original SLS

No interventions assigned to this group

Asthma

Subjects with asthma who were randomised to treatment in the original SLS.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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US GSK Clinical Trials Call Center

Role: CONTACT

Phone: 877-379-3718

Email: [email protected]

EU GSK Clinical Trials Call Center

Role: CONTACT

Phone: +44 (0) 20 89904466

Email: [email protected]

Facility Contacts

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US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Center

Role: backup

References

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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.

Reference Type DERIVED
PMID: 40158113 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34357561 (View on PubMed)

Other Identifiers

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207531

Identifier Type: -

Identifier Source: org_study_id