This phase II trial will compare two doses of epinastine nasal spray to placebo. The trial will be conducted during the mountain cedar pollen season, which typically begins in early December, primarily in central Texas.
There are multiple objectives of this dose-ranging trial, including the measurement of nasal and non-nasal symptoms, quality of life scores and standard safety assessments. The doses being studied in this trial were selected based on a small phase II trial completed in October 2006, combined with preclinical pharmacology data compiled to date.
“An antihistamine that is delivered directly to the nose as a nasal spray has the potential to be effective in providing rapid relief for allergy patients with minimal side effects,” stated Paul Ratner, medical director of Sylvana Research Associates.
Inspire said it expected to report the trial results by mid-year 2007. Inspire previously acquired certain exclusive rights from Boehringer Ingelheim to develop and market an intranasal dosage form of epinastine in the US and Canada for the treatment or prevention of rhinitis.