fluticasone-propionate--salmeterol-xinafoate-drug-combination and Rhinitis--Allergic--Perennial

β(2)-Agonists have previously been shown to be effective inhibitors of mediator release from airway mucosal mast cells.. To evaluate the effects of intranasal salmeterol and fluticasone propionate alone and in combination on the response to nasal adenosine monophosphate (AMP) challenge to assess mast cell activation.. Twenty-three patients with persistent allergic rhinitis completed a randomized, double-blind, placebo-controlled, 4-way crossover trial. They received once daily treatment with placebo, salmeterol, 50 μg, fluticasone propionate, 500 μg, or fluticasone propionate and salmeterol combination, 500/50 μg, delivered via an antistatic spacer with nasal adapter for 1 week each, with trough measurements being made 12 hours after the first and last dose. The primary outcome was the maximum percentage decrease in peak nasal inspiratory flow after nasal AMP challenge.. For the primary outcome there was significant protection after single and long-term dosing with fluticasone alone and fluticasone-salmeterol combination, whereas salmeterol alone only afforded protection after the first dose. Fluticasone-salmeterol combination and fluticasone but not salmeterol conferred significant chronic dosing effects on secondary outcomes of nasal symptoms and disease-specific quality of life. There was no potentiation of the response to fluticasone by salmeterol on any outcomes when given in combination.. Chronic dosing with fluticasone but not salmeterol confers anti-inflammatory activity against nasal AMP challenge, but there was no potentiation of fluticasone when given in combination with salmeterol. Thus, salmeterol may not be an effective treatment for use in allergic rhinitis.. clinicaltrials.gov Identifier: NCT01388595.

Topics: Adenosine Monophosphate; Administration, Intranasal; Adrenergic beta-2 Receptor Agonists; Adult; Albuterol; Androstadienes; Anti-Allergic Agents; Cross-Over Studies; Double-Blind Method; Drug Combinations; Female; Fluticasone; Fluticasone-Salmeterol Drug Combination; Glucocorticoids; Humans; Male; Rhinitis, Allergic, Perennial; Salmeterol Xinafoate; Treatment Outcome

Intranasal and inhaled corticosteroid administration concurrently in comorbid allergic rhinitis (AR) and asthma may potentially enhance cortisol suppression. This study determined whether intranasal ciclesonide 200 micro g once daily has an additional effect on cortisol suppression when coadministered with inhaled fluticasone propionate-salmeterol (FP-SAL) 500 to 50 micro g twice daily. Adults (N = 150) with perennial AR received FP-SAL and placebo nasal spray during the run-in period. Patients were randomized to ciclesonide or placebo and FP-SAL (43 days). A single 2-mg dose of dexamethasone was administered on the last treatment day. Plasma cortisol decreased during run-in period (p < 0.001), indicating cortisol suppression by FP-SAL. After ciclesonide was added to FP-SAL, plasma cortisol was similar in both groups. Dexamethasone decreased mean plasma cortisol (p < 0.001), demonstrating that further suppression was possible. Ciclesonide coadministered with FP-SAL did not have an additive effect on cortisol suppression compared with FP-SAL.

Topics: Administration, Inhalation; Administration, Intranasal; Adolescent; Adult; Albuterol; Androstadienes; Anti-Allergic Agents; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Female; Fluticasone-Salmeterol Drug Combination; Humans; Hydrocortisone; Male; Middle Aged; Pregnenediones; Rhinitis, Allergic, Perennial