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

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.

Efficacy and tolerability of azelastine nasal spray in the treatment of allergic rhinitis: large scale experience in community practice.

Two Spanish prospective monitoring studies evaluated efficacy and tolerability of azelastine nasal spray containing azelastine hydrochloride for allergic rhinitis. Both studies were conducted by community practitioners over two weeks (Study I) or one month (Study II). The numbers of patients recruited were 3680 (I) and 4002 (II). Of these, 56.1% (I) and 51.7% (II) had been previously treated with oral antihistamines with/without other medications. Patients rated the severity of 10 symptoms of allergic rhinitis as absent, mild, moderate or severe. Azelastine nasal spray was generally administered at a dose of one spray puff (0.14 mg) per nostril twice daily. Follow-up was after 14 days (I) or 31 days (II), when symptoms were rated and patients questioned about treatment. Assessment was by a sum score for all 10 symptoms. A symptom sum score of 16-20 occurred in 21.1% (I) and 13.7% (II) of patients before treatment and only 0.8% (I) and 0.6% (II) after treatment. A symptom sum score of 11-15 occurred in 35.9% (I) and 30.5% (II) of patients before treatment and only 2.6% (I) and 2.8% (II) after treatment. Overall, 92.3% (I) and 90.7% (II) of patients were completely free of adverse events, 7.0% (I) and 8.8% (II) experienced one and 0.7% (I) and 0.6% (II) two adverse events. The number of doctors who rated efficacy as either very good or good was 89.4% (I) and 84.6% (II). General tolerance was rated as good or very good by 97.5% (I) and 97.3% (II), and local tolerance by 93.1% (I) and 91.5% (II) of physicians, respectively. Overall, azelastine nasal spray was highly effective and very well tolerated in normal clinical practice.