PMID- 9272242
OWN - NLM
STAT- MEDLINE
DCOM- 19971009
LR  - 20121115
IS  - 0004-4172 (Print)
IS  - 0004-4172 (Linking)
VI  - 47
IP  - 7
DP  - 1997 Jul
TI  - Evaluation of the drug monitoring programme of azelastine hydrochloride nasal 
      spray in the treatment of allergic rhinitis in children under 13 years of age.
PG  - 841-4
AB  - 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.
FAU - Wober, W
AU  - Wober W
AD  - Munich Institute for Medical Research (MIM), Germany.
FAU - Diez Crespo, C D
AU  - Diez Crespo CD
FAU - Bahre, M
AU  - Bahre M
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PL  - Germany
TA  - Arzneimittelforschung
JT  - Arzneimittel-Forschung
JID - 0372660
RN  - 0 (Histamine H1 Antagonists)
RN  - 0 (Phthalazines)
RN  - ZQI909440X (azelastine)
SB  - IM
MH  - Administration, Intranasal
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Histamine H1 Antagonists/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Male
MH  - Phthalazines/administration & dosage/adverse effects/*therapeutic use
MH  - Product Surveillance, Postmarketing
MH  - Rhinitis, Allergic, Perennial/*drug therapy/physiopathology
MH  - Rhinitis, Allergic, Seasonal/*drug therapy/physiopathology
EDAT- 1997/07/01 00:00
MHDA- 1997/07/01 00:01
CRDT- 1997/07/01 00:00
PHST- 1997/07/01 00:00 [pubmed]
PHST- 1997/07/01 00:01 [medline]
PHST- 1997/07/01 00:00 [entrez]
PST - ppublish
SO  - Arzneimittelforschung. 1997 Jul;47(7):841-4.