MB29599 - A Study to Assess Biomarkers in Patients with Severe Asthma
Research type
Research Study
Full title
A Prospective, Single Arm, Longitudinal Cohort Study to Assess Biomarkers in Real World Patients with Severe Asthma
IRAS ID
181927
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Clinicaltrials.gov Identifier
2015-000742-35, EUDRACT Number
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This single arm longitudinal multicenter study is designed to assess the relationships between asthma prognostic biomarkers (biological indicators) and asthma related health outcomes in adult patients with severe asthma. Patients must require treatment with a daily inhaled corticosteroids (ICS) and at least one of the following controller medications: long-acting β-agonists (LAMAs), Leukotriene receptor antagonists (LTRAs), long-acting muscarinic antagonists (LAMAs), theophylline or oral corticosteroids.
There is no screening period required as all eligibility criteria can be determined at the baseline visit. Patients will be followed for 52 weeks. After the baseline visit patients will be required to attend two further hospital visits for assessments at week 26 and at the end of the study at week 52. In between these visits patients will participate in two telephone interviews to review the staus of their asthma and changes in their health.
Patients will be treated according to their doctor’s routine practice. There will be no additional treatment provided as part of this study. Patients will receive additional clinical assessments, be required to give blood samples at each visit and to complete health related questionnaires at each visit and phone interview.
A total of 1213 patients will take part in this study globally. 75 patients are expected to be enrolled at 10 UK hospitals
The study is sponsored by F. Hoffman La Roche
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0310
Date of REC Opinion
16 Jul 2015
REC opinion
Favourable Opinion