According to research presented at the annual meeting of the American College of Allergy, Asthma, and Immunology ciclesonide HFA (i.e., ciclesonide with a hydrofluoroalkane propellant) has been reported to improve the symptoms of perennial allergic rhinitis compared to placebo.
The phase III trial involved 1,110 patients aged over 12 years with at least a two-year history of perennial allergic rhinitis who were randomised to receive treatment with ciclesonide HFA 74 mcg (n=298), ciclesonide HFA 148 mcg (n=505), and placebo (n=307). Each day, patients self- administered one spray per nostril and recorded their total nasal symptom score (TNSS), which includes postnasal drip, sneezing, itchy nose and nasal congestion, on a scale of zero to 3, with 3 being the worst.
According to the researchers, both doses were statistically significantly superior to placebo, both in the reflective TNSS, where patients reported how they felt over the past 24 hours (P<0.01 for both) and in the instantaneous TNSS, where they reported how they felt just before they took their next dose (P<0.05 for both). Additionally, the overall incidence of side effects was reported to be comparable between all treatment groups, with the most frequently reported side effects being headache, nasopharyngitis, upper respiratory tract infections, viral upper respiratory tract infections, sinusitis, and epistaxis.
The company reports that the New Drug Application for ciclesonide nasal aerosol was accepted for filing by the U.S. Food and Drug Administration in June 2011 and is currently under review.