Once-daily dosing of levocabastine has comparable efficacy to twice-daily dosing in the treatment of allergic rhinitis assessed in an allergen challenge chamber.

Abstract

OBJECTIVES:

To test the hypothesis that intranasal levocabastine (LEVO) may provide benefits as a oncedaily treatment in allergic rhinitis (AR), this non-inferiority study compared the effect at steady state of once- and twice-daily dosing with LEVO on allergen-induced nasal symptoms in AR patients.

METHODS:

This was a randomized, double-blind, three-way cross over study evaluating the effects of repeat doses of LEVO 200 µg once-daily, LEVO 200 µg twice-daily (total dose 400 µg) and placebo, all via intranasal spray, in 78 AR patients. The primary endpoint was weighted mean total nasal symptom score (TNSS) during a 4-hour allergen exposure in the Environmental Exposure Chamber measured at trough pharmacokinetic levels either 12 (LEVO twice-daily) or 24 (LEVO once-daily) hours post-dose.

RESULTS:

After 7 days dosing, the difference in weighted mean TNSS (0-4 hours) following LEVO once-daily versus twice-daily was 0.23 units (95% CI -0.36, 0.82), demonstrating noninferiority between the two LEVO dosing regimens by meeting the pre-specified criterion of an upper limit of 95% CI<1.0. Both dosing regimens of LEVO resulted in a statistically significant reduction in mean TNSS compared with placebo (adjusted mean difference from placebo: LEVO once-daily: -1.12 (95% CI -1.71, -0.53); LEVO twice-daily: -1.35 (-1.94, -0.76)), meeting the pre-specified criterion for superiority (upper limit of 95% CI<0). All treatments were well-tolerated.

CONCLUSIONS:

The results of this study support the hypothesis that at steady state LEVO 200 µg taken once-daily provides similar benefit to LEVO 200 µg dosed twice-daily.

• Authors: Robert D Murdoch, Philippe Bareille, Diane Ignar, Stephen Mark, Sam R Miller, Ashutosh Gupta, Anne-Marie Salapatek, Piyush Patel
• Journal: International journal of clinical pharmacology and therapeutics (Int J Clin Pharmacol Ther) Vol. 53 Issue 10 Pg. 811-8 (Oct 2015) ISSN: 0946-1965 [Print] Germany
• PMID: 26249767 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Histamine H1 Antagonists, Non-Sedating
• Piperidines
• levocabastine

Topics

• Adult
• Cross-Over Studies
• Double-Blind Method
• Drug Administration Schedule
• Female
• Histamine H1 Antagonists, Non-Sedating (administration & dosage)
• Humans
• Male
• Middle Aged
• Piperidines (administration & dosage, adverse effects)
• Rhinitis, Allergic (drug therapy, physiopathology)
• Young Adult