Risk factors predisposing to difficult urticaria. Version 1.
Research type
Research Study
Full title
Risk factors predisposing to difficult urticaria: an observational study
IRAS ID
181696
Contact name
Richard Baretto
Contact email
Sponsor organisation
Heart of England NHS Foundation Trust
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Urticaria is a raised, itchy skin rash, also known as 'hives' or 'nettle rash' that often co-exists with recurrent swellings of the skin (angioedema). Urticaria is common, with a lifetime prevalence of at least 8.8% (Zuberbier T et al 2010). When the rash lasts for more than 6 weeks or when it keeps coming back, it is known as chronic urticaria (Bernstein J.A. et al 2014). Chronic urticaria, affects up to 5% of the population (Bernstein J.A et al 2014), and can last for months or years; the cause is often unknown. Studies have shown that urticaria significantly affects the quality of life of affected individuals (Maurer M et al 2008). Patients with the condition are also more likely to suffer from psychological problems such as depression or anxiety (Ben-Shoshan M et al 2013).
The mainstay of treatment is standard doses of non-drowsy antihistamines. However, a proportion of patients do not improve with these and the condition can become very troublesome. Furthermore, some patients with chronic urticaria are prone to particularly severe life-threatening attacks with widespread hives associated with swelling of the tongue and/ or upper airway, causing breathing difficulties, and rarely a drop in blood pressure. There are no reliable tests or clinical indicators to predict which patients are likely to develop antihistamine unresponsive (difficult urticaria) or severe life-threatening attacks.
In this study we aim to characterise patients with chronic urticaria and develop a clinical model, which may help to predict which patients will develop difficult urticaria and those who may be prone to developing life-threatening attacks. This would enable clinicians to manage these patients by introducing stronger and more effective treatments earlier on in the disease course and bypassing the need for futile and expensive medications, potentially reducing costs for the NHS and opening up avenues for psychological interventions.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
17/WM/0353
Date of REC Opinion
2 Nov 2017
REC opinion
Further Information Favourable Opinion