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Completed

NCT Number: NCT03152669

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Manchester, M274AF, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Retrospective EMR data

    Time frame: Up to 10 years

    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.

  2. Prospective EMR data

    Time frame: Up to 10 years

    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.

  3. Risk factor questionnaire

    Time frame: Up to 10 years

    Historical demographic, COPD/asthma risk factor information and clinical data not routinely available. Collected via paper questionnaire.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
May 15, 2017
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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