Evaluation of the drug monitoring programme of azelastine hydrochloride nasal spray in the treatment of allergic rhinitis in children under 13 years of age. (1997)

The efficacy and safety of a nasal spray containing azelastine (CAS 58581-89-8; e.g. Afluon, Allergadil, Rhinolast) in the treatment of both perennial and seasonal allergic rhinitis have been evaluated in two postmarketing drug surveillance programmes (PMS) conducted in Spain. The present analysis reports on the data from a subpopulation from these studies and includes 211 children aged less than 13 years of age. In 73% of children the administered dose of azelastine was one spray puff per nostril twice daily, corresponding to the recommended daily, dosage of 0.56 mg azelastine. Patients with seasonal rhinitis were treated for a period of two weeks, those perennial rhinitis were treated for four weeks. The efficacy of the azelastine was assessed by the changes in severity of the following 10 individual symptoms of rhinitis: sneezing, nose itching, nose congestion, rhinorrhoea, smell reduction, eye itching, lachrimation, photophobia, throat itching, and coughing. Symptoms were rated according to a four-point scale: 0 = absent, 1 = slight, 2 = moderate, and 3 = severe. Both the investigators and the patients were requested to evaluate efficacy and tolerance according to a four point scale: 1 = very good, 2 = good, 3 = moderate, 4 = bad. All of the 10 clinical symptoms underwent a statistically significant and clinically relevant reduction during the treatment period. Nose itching, sneezing, and rhinorrhoea were the symptoms which completely disappeared in the highest number of patients by the end of therapy. The mean sum of all 10 symptom scores pre-treatment (baseline visit) was 11.03 while at the completion of therapy (control visit) it was 3.21. Overall, a decrease of this score was seen in 112 (98%) patients for whom complete data was available, whereas an increase was registered only in 2 (2%) cases. The mean total of the five nasal scores at the baseline visit was 7.64, and at the control visit its value measured 2.31. One hundred and twenty-one (98%) patients exhibited a decrease in the total nasal score, and only 3 (2%) demonstrated an increase. The mean total of the three ocular symptoms scores at the baseline visit was 2.25, while at the control visit its value was only 0.48. A decrease in the total ocular score was observed in 78 (62%) patients, while an increase occurred in only one patient. Overall, 85% of doctors evaluated the efficacy of the drug as "very good/good". 90% of patients did not report adverse events (AEs) during treatment with azelastine and only four patients discontinued treatment due to AEs. General tolerance was evaluated as "very good or good" by 97% of the treating physicians. Local tolerance was rated as "very good or good" by 94%. The most positive characteristics of the therapy according to the physicians were: rapid onset of action in 56% of cases, good efficacy in 46%, simple application in 44%, no sedation in 34%, and long duration of action in 22% of cases. Based upon the excellent risk-benefit assessment of this PMS, our results confirm the suitability of azelastine nasal spray in the treatment of allergic rhinitis in juvenile patients.