Identification and Description of Severe Asthma Patients - IDEAL
Research type
Research Study
Full title
Identification and Description of Severe Asthma Patients in a Cross-sectional Study — the IDEAL Study
IRAS ID
169601
Contact name
Nick Jones
Contact email
Duration of Study in the UK
0 years, 8 months, 19 days
Research summary
This study is designed to describe the population of severe asthma subjects that meet the eligibility criteria for one or more of the following medication(s) per local prescribing information: mepolizumab, omalizumab, and reslizumab. Data will be collected across several countries in order to provide a more reliable description of the current outlook for severe asthma patients with respect to the potential eligibility for these three treatments.
During this single visit study, subjects (> 12 years old) with severe asthma will be invited to attend the nearest trial centre to discuss the study and their potential participation. If a subject agrees and is eligible, the medical records of each subject will be extracted and reviewed for any historical measurements of breathing tests (known as spirometry and airway reversibility), prior asthma medication use (including a specific drug called a corticosteroid), and a history of any worsening or increase in severity of signs and symptoms of asthma in the prior 12 months.
Other assessments will include height, weight, ethnic origin, other medical history (including family history), smoking history, and a physical examination. The subjects will also undertake a blood test and may be asked to perform breathing tests if these have not been performed in the prior 12 months. Subjects will be able to continue their current asthma and other medications during this study, unless a breathing test is required.
The subjects will also be asked to complete six questionnaires (prior to any breathing tests, if required) which will further investigate their health-related quality of life which is often heavily impacted by severe asthma. Adverse events will also be recorded. A subject’s participation in this study will be complete once they have left the clinic.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0030
Date of REC Opinion
23 Jan 2015
REC opinion
Further Information Favourable Opinion