Treatment patterns for severe uncontrolled asthma
Research type
Research Study
Full title
A retrospective observational study to determine the baseline characteristics and treatment patterns of patients with severe uncontrolled asthma in the UK
IRAS ID
260765
Contact name
Brian Lipworth
Contact email
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
Summary of Research
The study is interested in patients with severe, uncontrolled asthma. We want to look at how these patients are currently treated (i.e. current treatment patterns) and the impact this has on the healthcare system in terms of resource use. For example, what medication they are prescribed, how often do they have routine hospital appointments and whether they have had any emergency visits or hospitalizations due to their asthma. In order to do this, hospital research staff will be asked to provide patient information taken from patient medical records by entering this into a standardized, anonymised form. Patients themselves will not be directly involved in the research but their historic medical record information will be used. It is expected that approximately 5 UK hospitals will be involved in the study and will provide information on approximately 150 adults with severe, uncontrolled asthma. Data collection should only last 1 -3 months to allow the research teams enough time to complete the study forms.
An understanding of current care for severe, uncontrolled asthma will allow the impact of new treatments to be assessed. Dupilumab is one such new treatment that is expected to be available later this year. Currently, in the published literature there is minimal information describing UK healthcare resource use or treatment patterns for this patient group so it is difficult to assess the impact of dupilumab against current standard of care.Summary of Results
The study was interested in patients with severe, uncontrolled asthma. We wanted to look at how these patients are currently treated (i.e. current treatment patterns) and the impact this has on the healthcare system in terms of resource use. For example, what medication they are prescribed, how often do they have routine hospital appointments and whether they have had any emergency visits or hospitalizations due to their asthma. In order to do this, hospital research staff were asked to provide patient information taken from patient medical records by entering this into a standardized, anonymised form. Patients themselves were not directly involved in the research but their historic medical record information was used. 3 UK hospitals were involved in the study and provided information on 81 adults with severe, uncontrolled asthma.
An understanding of current care for severe, uncontrolled asthma allowed the impact of new treatments to be assessed. In the published literature there was minimal information describing UK healthcare resource use or treatment patterns for this patient group so it was difficult to assess the impact of novel drugs against current standard of care. The study revealed poor clinical test results, presence of severe exacerbations throughout the observation period, multiple per-patient treatment prescriptions (both acute & maintenance therapy), a high level of consultations & hospitalisations, and poor asthma control indicated by PROs. These findings demonstrate that there is high resource use and poor QoL among these patients with severe uncontrolled asthma, suggesting novel therapies are required. The potential value of approval of novel drugs as an add-on maintenance treatment for patients with inadequately controlled severe asthma driven by Type 2 inflammation is clearly highlighted.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0209
Date of REC Opinion
16 Apr 2019
REC opinion
Favourable Opinion