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

GlaxoSmithKline (GSK)

Status: Enrolling

Conditions: Asthma

Study type: Observational

Funder types: Industry

Identifiers

NCT03152669

207531

Details and patient eligibility

About

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.

Enrollment: 3,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,500 participants in 2 patient groups

Chronic obstructive pulmonary disease

Description:

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

Asthma

Description:

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