RECOGNISE V5.0
Research type
Research Study
Full title
Characterisation of patients with severe asthma in primary and secondary care settings in Europe reported to be eligible for biological therapy (Recognise Study)
IRAS ID
249714
Contact name
Dermot Ryan
Contact email
Sponsor organisation
AstraZeneca PLC
Clinicaltrials.gov Identifier
NCT03629782, NCT
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
Asthma is a chronic inflammatory disease that is estimated to affect 300 million people globally, resulting in a significant burden to healthcare systems and society. Patients typically have respiratory symptoms including wheeze, shortness of breath, chest tightness and cough, together with variable expiratory airflow limitation. Most patients with asthma can be effectively treated with currently available pharmacological therapies, meaning their asthma is well controlled with few troublesome symptoms, little need for reliever medication, the capacity to perform normal daily activities and no or infrequent exacerbations. However, a subset of patients have severe asthma, which is characterized by difficulty to achieve disease control despite high-intensity treatment and accounts for a relatively large proportion of asthma-associated morbidity and healthcare costs.
Severe asthma is increasingly recognised as a major unmet need. Therefore, the identification of asthma phenotypes in this patient group is becoming an important part of managing the disease. Identifying patients who could benefit from novel biologic therapies (only administered in specialised UK centres) is becoming a key factor for some severe asthma patients, facilitating targeted and personalised treatment. Accurate identification of these patients may be difficult outside of specialist asthma care centres given the lack of access to diagnostic tools and expertise. To our knowledge there are scarce epidemiological data on severe asthmatics in primary care and non-specialized healthcare settings.
This study aims to generate real world data on the characteristics of patients with severe asthma in primary and secondary care settings who could potentially benefit from the referral for biologic therapy after further clinical assessment.
We anticipate that these data will help to estimate the unmet need for access to novel biologic treatments for severe asthma patients; evidence describing the current referrals to specialist centres. This information could support the development of better severe asthma care pathways.REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/1579
Date of REC Opinion
13 Nov 2019
REC opinion
Unfavourable Opinion