Comparison of the efficacy and tolerability of topical levocabastine and sodium cromoglycate in the treatment of seasonal allergic rhinoconjunctivitis in children

Abstract

Children (n = 110) with seasonal allergic rhinoconjunctivitis were randomized to receive either twice daily 0.05% levocabastine eye drops and nasal spray plus twice daily topical placebos or 2% sodium cromoglycate eye drops and nasal spray four times daily for a period of 4 weeks. Patients were required to use the nasal sprays as directed and the eye drops only when required. The results obtained suggest that topical levocabastine is at least as effective as sodium cromoglycate for the treatment of this condition. After 2 weeks treatment the effect of therapy on nasal symptoms was considered to be excellent or good in 72% of levocabastine-treated patients and 54% of patients on sodium cromoglycate (p = 0.009), with corresponding values for ocular symptoms of 81% and 57% in the two groups, respectively (p < 0.05). Investigator assessments also revealed that the severity of sneezing and lacrimation were significantly lower in the levocabastine group at this time (p < 0.05). After 4 weeks of treatment, patient diary data revealed that levocabastine was at least as effective as sodium cromoglycate with intergroup differences attaining statistical significance in favor of the topical antihistamine for nasal congestion (p < 0.05). Both agents were well-tolerated with no significant differences in the incidence or type of adverse reactions in the two treatment groups.

Allergic Rhinitis and its Impact on Asthma (ARIA) 2008*

“…Disodium cromoglycate has been one of the common drugs used for allergic rhinoconjunctivitis in children but it is less effective than intranasal glucocorticosteroids or H 1 -antihistamines (2233,2235,2236). It is important to note that in children, these drugs are free from side effects.…”

“…However, although there is a beneficial effect upon symptoms in the organ to which they are administered, they usually have little effect elsewhere. These drugs are useful in children with symptoms limited to the nose or the eyes (1408,2233,2234).…”

Double-masked, randomized, parallel-group study comparing olopatadine 0.1% ophthalmic solution with cromolyn sodium 2% and levocabastine 0.05% ophthalmic preparations in children with seasonal allergic conjunctivitis

“…The present findings may be compared to those of 4 previously published trials [14][15][16][17] in children and adolescents with SAC and seasonal allergic rhinoconjunctivitis. Two of these trials 14,15 showed patient global ratings for levocabastine 0.05% eye drops BID to be higher than those for cromoglycate sodium 2% eye drops QID (P < 0.05).…”

“…Two of these trials 14,15 showed patient global ratings for levocabastine 0.05% eye drops BID to be higher than those for cromoglycate sodium 2% eye drops QID (P < 0.05). The third trial 16 compared nedocromil sodium 2% eye drops (BID) with vehicle (control).…”

Pediatric allergy medications: review of currently available formulations

“…Topical mast cell stabilizers, such as cromolyn sodium or nedocromil, have also been found safe in children 48 but not as effective as H 1 -antihistamines or INSs in the treatment of seasonal allergic rhinitis (SAR) 48,[50][51][52] . Mast cell stabilizers provide maximum efficacy when begun prior to symptom onset 33,53 , although relief may take several weeks 54 and frequent dosing (up to six times daily) may reduce compliance 33,48,53 .…”