ALPHA
Research type
Research Study
Full title
Analysis of Lung Physiology and Health in Alpha-1 Antitrypsin Deficiency
IRAS ID
277879
Contact name
Tom Wilkinson
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
5 years, 11 months, 31 days
Research summary
The proposed study is a longitudinal cohort study to facilitate better understanding and management of patients with Alpha-1 Antitrypsin Deficiency (AATD) encountered in clinical practice. AATD was initially described in 1963, and is best known as an inherited form of Chronic Obstructive Pulmonary Disease (COPD). The condition is estimated to affect approximately 3.4 million individuals worldwide. Since its first description, there have been few studies describing the natural history of the disease and even fewer studies relating to treatment of the condition. Patients with AATD usually develop lung and liver disease that is irreversible and often progressive. No cure exists for the condition at present. The aim of this study is to increase our understanding of the natural history of AATD, identify similarities to smoking-related lung disease, and by extension, pave way for introduction of novel therapies in the treatment of AATD. The study will be based at University Hospital Southampton (UHS) NHS Foundation Trust, and will be sponsored by UHS. As this is a cohort study, the study will run potentially indefinitely and participants will be followed up at regular intervals. This study is being conducted in a combined clinical and research setting, so that the research visit will be combined with the usual clinical appointment. Participants will provide an updated clinical history, undergo routine physical examination, and have investigations generally performed in an outpatient setting such as blood tests, sputum samples, urine samples, lung function tests, and imaging as required. Where investigations are done for purely academic purposes, a separate consent form will be required.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
20/NE/0080
Date of REC Opinion
23 Jun 2020
REC opinion
Further Information Favourable Opinion