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

Study Overview
=================
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.

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

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic obstructive pulmonary disease<br>Subjects with COPD who were randomised to treatment in the original SLS | |
| Asthma<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, Chronic obstructive pulmonary disease, Salford Lung Study