Comparative safety and efficacy of 2 formulations of fluticasone aqueous nasal spray in persistent allergic rhinitis

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Abstract

Background:

There are few data on the clinical equivalence of different nasal corticosteroids in persistent allergic rhinitis (AR). Studies measuring plasma concentrations after a single dose may not predict relative systemic bioactivity at steady state.

Objective:

To compare a test formulation of fluticasone propionate with the innovator using a noninferiority design.

Methods:

Twenty-three patients with persistent AR were randomized to completion in a double-blind, placebo-controlled, crossover manner to receive the formulations at 200 μg/d for 4 weeks, with baselines measured after 2-week run-in and washout periods. The primary outcome measure was the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) score.

Results:

Both formulations produced significant improvements in MiniRQLQ scores as change from baseline (P < .001), with a nonsignificant mean difference (test vs innovator) of −0.06 U (95% confidence interval [CI], −0.41 to 0.52 U) and the lower bound of the 95% CI being above the predefined noninferiority limit of −0.7 U. Both formulations produced significant improvements in peak nasal inspiratory flow rates as change from baseline (P < .01), with a nonsignificant mean difference of 0.5 L·min−1 (95% CI, 9.8 to 10.8 L·min−1). There were also significant reductions in total nasal symptom scores (P < .01), with a nonsignificant mean difference of 0.4 U (95% CI, 0.3 to 1.1 U). No significant suppression of the 10-hour overnight urinary cortisol to creatinine ratio was seen with either formulation.

Conclusions:

The test formulation was noninferior to the innovator for the primary outcome of MiniRQLQ score. The secondary efficacy and safety end points also support the interchangeability of the 2 formulations.

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