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Levocabastine: a new topical approach for the treatment of paediatric allergic rhinoconjunctivitis
1Dept. of Clinical Research and Development, Janssen Research Foundation, Beerse, Belgium.
Insights
Levocabastine, a topical H1-receptor antagonist, effectively treats allergic rhinitis and conjunctivitis. It offers rapid symptom relief with a safety profile comparable to placebo and cromoglycate.
Area of Science:
- Ophthalmology
- Allergology
- Pharmacology
Background:
- Levocabastine is a novel H1-receptor antagonist developed for topical application.
- It is indicated for allergic rhinitis and conjunctivitis.
Purpose of the Study:
- To evaluate the efficacy and safety of levocabastine in treating allergic rhinitis and conjunctivitis.
- To compare levocabastine with placebo and cromoglycate.
Main Methods:
- Clinical studies involving 1,363 patients with allergic rhinitis and 1,218 patients with allergic conjunctivitis.
- Administration via nasal spray or eye drops, with dosages adjusted as needed.
- Comparison against placebo and cromoglycate, with efficacy assessed through symptom reporting and global evaluations.
Main Results:
- Levocabastine significantly outperformed placebo in alleviating sneezing, itching, runny nose, itchy eyes, red eyes, and lacrimation.
- Good to excellent results were reported by approximately 60% of nasal spray users and 75% of eye drop users.
- Onset of action was rapid, with 73% experiencing relief within 30 minutes. Safety profiles were similar across levocabastine, cromoglycate, and placebo groups, with nasal/ocular irritation being the most common complaint.
Conclusions:
- Levocabastine is an effective topical antihistamine for allergic rhinoconjunctivitis in adults.
- Preliminary data suggest similar efficacy and safety in children.
- It demonstrates comparable or superior efficacy to cromoglycate with a favorable safety profile.
Abstract:
Levocabastine is a novel H1-receptor antagonist for topical use, which is being investigated in allergic rhinitis (nasal spray) and conjunctivitis (eye drops). Its anti-allergic effects have been demonstrated in nasal and ocular provocation tests. Clinical studies have been performed in 1,363 patients with allergic rhinitis and 1,218 patients with allergic conjunctivitis, comparing levocabastine mainly to placebo and cromoglycate. Levocabastine was effective when used at a dose of 2 sprays per nostril or 1 drop per eye twice daily, which if necessary can be increased up to four times daily. Levocabastine was superior to placebo in alleviating symptoms such as sneezing, itchy nose, runny nose, itchy eyes, red eyes and lacrimation. In global evaluations some 60% of patients had good to excellent results with the nasal spray and some 75% with the eye drops. Levocabastine was shown to be as good or even slightly better than cromoglycate. Onset of action was fast, with 73% of patients reporting symptom relief within 30 min after administration of levocabastine nasal spray. Adverse experiences were similar in type and incidence with levocabastine, cromoglycate and placebo, for nasal spray as well as eye drops. The most frequent complaints were nasal and ocular irritation, respectively, with a similar incidence for the three drugs. Limited data are available in children so far, but they indicate response rate and adverse-experience profile to be similar to what was observed in adults. Levocabastine, thus, is an interesting new antihistamine available for topical use in allergic rhinoconjunctivitis. It has been extensively evaluated in adults, and preliminary data indicate that it can also be useful in allergic children.