Th2-low endotype biomarkers in exercise-induced asthma (Version 1.0)
Research type
Research Study
Full title
Inflammatory and functional biomarkers of the Th2-low endotype in exercise-induced asthma
IRAS ID
203756
Contact name
Omar Usmani
Contact email
Sponsor organisation
Imperial College
Eudract number
2016-002907-24
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Asthma is a heterogeneous disease including different forms based on clinical and functional characteristics (phenotypes), such as exercise-induced asthma (EIA). The term “endotype” has been recently suggested to identify a subtype of the disease defined by pathophysiological mechanisms and treatment response. The most common approach for identifying asthma endotypes is centered on the immune response mediated by cells called T helper-2 (Th2) lymphocytes (Th2-low vs Th2-high). The definition of the "Th2-low" (non-allergic) EIA is however made, at present, only by exclusion of a "Th2-high" (allergic) signature. The lack of specific “Th2-low” biological markers therefore prevents from a proper identification of this endotype. Furthermore, despite management of EIA is effectively based on bronchodilators, high variability in individual patient responses and occurrence of tolerance to treatment have been reported, suggesting the need of endotype-driven therapy. At last, it is not known if the occurrence of asthma exacerbations might induce changes in the endotype expression along time. Further research has been therefore prompted to address the above mentioned unmet needs, especially in EIA which significantly affects quality of life of the many subjects practicing physical activity.
Non-smoker male and female athletes, aged 18-65 yrs. with evidence of EIA will be eligible for entering the study.
This is a single center study including 3 visits across a 4-week time period, plus a 52 week observational follow up.
The following study procedures will be adopted: AQUA questionnaire; Skin-Prick Testing; Pulmonary Function tests; Exercise challenge (following a single prophylactic dose of salbutamol or ipratropium in a crossover design and random order); Impulse oscillometry; Fraction exhaled nitric oxide; Multiple breath nitrogen washout; Heart rate variability analysis; Exhaled breath temperature. Biological samples will be also collected for measuring inflammatory biomarkers and investigating pathological agents responsible for exacerbations (bacteria, viruses).REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0335
Date of REC Opinion
12 Oct 2016
REC opinion
Favourable Opinion