Efficacy and safety of intranasally applied dimetindene maleate solution -Multicenter study in children under 14 years suffering from seasonal allergic rhinitis

The aim of this study was to investigate the efficacy and tolerability of i ntranasally applied dimetindene (CAS 3614-69-5) 0.1 % spray in children suf fering from seasonal allergic rhinitis. A total of 100 children under 14 years with acute seasonal allergic rhiniti s participated in this randomised, single-blind, reference-controlled multi -center parallel group study with two treatment groups. The study took plac e between 2nd April and 16th September 1996 during the pollen season. Patie nts were examined at enrolment (day 1), day 8 and day 15. Patients kept dia ry throughout the 2-week treatment phase. Patients were randomised to recei ve either dimetindene 0.1% (Fenistil (R) Nasal Spray) or a levocabastine (C AS 79516-68-0) 0.05 % solution as reference medication. Both medications we re supplied in similar outer packages. A single-blind approach was chosen, because the reference medication levocabastine requires two spray puffs per nostril as a single dose, whereas for dimetindene maleate solution a singl e spray puff per nostril is sufficient. Dimetindene 0.1% was applied with 1 spray puff (= 0.14 mg dimetindene) in each nostril and levocabastine with 2 spray puff (= 0.10 mg levocabastine) in each nostril every day in the mor ning before leaving the house and in the evening before going to bed. Addit ional administration of the spray was allo lowered up to 4 times a day if n eeded. Efficacy was assessed as change in severity of characteristic sympto ms associated with pollen rhinitis: nasal rhinorrhea, nasal itching, nasal sneezing and nasal congestion. in addition, changes in ocular symptoms, lac rimation, ocular itching and red eyes, global physician's assessment of eff icacy at the end of treatment were assessed. The primary criterion change o f total nasal symptom severity score between day 1 and day 3 resulted in a statistically equivalent and therapeutically relevant symptom reduction for the two treatments. Ad secondary criteria showed a similar reduction in sy mptoms, thus underlining the consistency of the findings. Both nasal sprays were well tolerated. It is concluded from these results that dimetindene 0 .1 % nasal spray solution is a safe and efficient treatment option for chil dren under 14 years suffering from seasonal allergic rhinitis.