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The CRTH 2 antagonist OC 000459 reduces nasal and ocular symptoms in allergic subjects exposed to grass pollen, a randomised, placebo‐controlled, double‐blind trial
Author(s) -
Horak F.,
Zieglmayer P.,
Zieglmayer R.,
Lemell P.,
Collins L. P.,
Hunter M. G.,
Steiner J.,
Lewis T.,
Payton M. A.,
Perkins C. M.,
Pettipher R.
Publication year - 2012
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1111/all.12042
Subject(s) - medicine , rhinomanometry , placebo , allergy , allergic conjunctivitis , crossover study , asthma , anesthesia , antagonist , gastroenterology , immunology , surgery , nose , pathology , receptor , alternative medicine
Background CRTH 2 mediates activation of Th2 cells, eosinophils and basophils in response to prostaglandin D 2 . The CRTH 2 antagonist OC 000459 has previously been demonstrated to reduce airway inflammation and improve lung function in moderate persistent asthma. The objective of the present study was to determine the involvement of CRTH 2 in promoting nasal and ocular symptoms in allergic subjects exposed to grass pollen. Methods A single centre, randomised, double‐blind, placebo‐controlled, two‐way crossover study was conducted in 35 male subjects allergic to grass pollen comparing OC 000459 200 mg bid with placebo for 8 days. Subjects were exposed to grass pollen (≥1400 grains/m 3 ) for 6 h on the 2nd and 8th days of treatment and assessed for nasal symptoms, ocular symptoms, other symptoms, nasal secretion weight and rhinomanometry over the 6‐h period. After a washout period of 3 weeks, subjects were switched to the alternative treatment for a further 8 days. The trial was registered on the clinical trials.gov database (Identifier NCT 01448902). Results During the first treatment period, treatment with OC 000459 significantly reduced both nasal and ocular symptoms in allergic subjects compared with placebo after challenge with grass pollen. A significant effect was observed on the 2nd day of dosing which was increased on the 8th day of dosing. The therapeutic effects of OC 000459 persisted into the second treatment period despite a 3‐week washout phase. The safety profile of OC 000459 was similar to that of placebo. Conclusion Treatment with OC 000459 was well tolerated and led to a significant and persistent reduction in the symptoms of rhinoconjunctivitis.