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

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 mu g/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% Cl 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 center dot min(-1) (95% CI, 9.8 to 10.8 L center dot 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.