Treatment of seasonal and perennial rhinitis with intranasal flunisolide.

Flunisolide (F), a potent fluorinated corticosteroid or its propylene/polyethylene glycol vehicle (V) were intranasally administered to 50 patients with ragweed hayfever and 75 patients with perennial rhinitis. Each patient was randomly assigned in a double-blind manner an indistinguishable metered pump spray device containing either F or V. Each hayfever patient administered two puffs in each nostril b.i.d. Each perennial rhinitis patient administered two puffs in each nostril t.i.d. Each puff of F contained 25 micrograms F. Hayfever and perennial rhinitis patients inhaling F demonstrated significantly lowered symptom scores compared to their V controls. Skin test positive patients with perennial rhinitis inhaling F demonstrated significantly large reductions in symptom scores and significantly greater subjective control of symptoms compared to their V control than their skin test negative counterparts inhaling F and V. Morning plasma cortisol measured prior to and at the end of 1 month and 3 months of F revealed no significant diminution in cortisol level compared to patients inhaling V. No long-term adverse local or systemic steroid effects attributable to F were observed. Flunisolide spray is a safe and effective modality for the treatment of seasonal and perennial rhinitis.

Efficacy of safety of concurrent use of intranasal flunisolide and oral beclomethasone aerosols in treatment of asthmatics with rhinitis.

Steroid-dependent, chronic asthmatic patients with severe rhinitis or nasal polyps are often candidates for treatment with intranasal topical corticosteroids, such as flunisolide. The possibility of additive adrenal suppression, when flunisolide, beclomethasone and prednisone are given together, has not previously been studied. The need to asses the risk is suggested by reports of additive adrenal suppression when aerosol and oral steroids are used together to treat asthma, and by the demonstrably higher systemic availability of aerosol steroid given intranasally rather than via the lung. We performed a double-blind, placebo-controlled crossover assessment of the efficacy and safety of 3 weeks of intranasal flunisolide spray treatment (300 micrograms/day) in nineteen steroid-dependent chronic asthmatic subjects, who also had nasal polyps or severe rhinitis. During the study, their doses of prednisone and beclomethasone, used for asthma, were held stable. Morning serum cortisol levels and 24-hr urinary-free cortisol excretion were essentially the same after the placebo, and the flunisolide treatments. The intranasal flunisolide improved their nasal symptoms significantly (P less than 0.05). Local complications were negligible. Given conventional steroid doses like those used in this study, there appears to be no important risk to endogenous adrenal function from combining the use of intranasal, flunisolide spray with administration of other steroids by other routes, when this is deemed clinically necessary. If higher doses are used, the possibility of some additive adrenal suppressive effect cannot be excluded.

Intranasal flunisolide in the treatment of perennial rhinitis: Correlation with immunologic parameters.

The effectiveness and safety of 200 micrograms/day of intranasal flunisolide in the treatment of perennial rhinitis was studied in 56 patients in a 6 wk double-blind parallel vehicle controlled clinical trial. In addition, patients failing to respond to placebo were entered into a 6 wk open trial with the active drug. Forty-six percent of the flunisolide-treated patients achieved total or substantial control of their nasal symptoms compared to 11% of the placebo-treated group in the double-blind study (p = 0.031). Eighty percent of patients achieved total or substantial control of their nasal symptoms in the 6 wk open study. No adverse effects attributable to flunisolide were observed. Parameters of IgE-mediated reactivity, including immediate-type skin test reactivity, total serum and nasal secretion IgE, specific serum and nasal secretion IgE, and nasal eosinophilia, were also assessed in these patients. Although benefit from flunisolide significantly correlated with all of these parameters except specific serum IgE, the absence of these findings did not preclude significant benefit from the drug. This study demonstrates the efficacy and safety of intranasal flunisolide in the treatment of perennial rhinitis, especially but not exclusively in those patients with evidence of IgE-mediated reactivity.

Flunisolide nasal spray for the treatment of children with seasonal allergic rhinitis.

Forty-eight children with seasonal allergic rhinitis received either 150 microgram/day of flunisolide (a new topical steroid) or placebo. Those receiving flunisolide had a significantly shorter daily duration of sneezing, stuffy nose, runny nose and throat itch. Total or substantial control of their symptoms was reported by 67% of the flunisolide group and 25% of the placebo group.

Treatment of ragweed hay fever with an intranasal spray containing fluinsolide, a new synthetic corticosteroid.

Flunisolide, a new synthetic fluorinated corticosteroid, was administered as a nasal spray via a squeeze bottle to patients with ragweed hay fever for 4 wk during the hay fever season. Fifty-one patients, paired on the basis of similar skin sensitivity to intradermal ragweed (greater than or equal to 10-1 PNU/ml), were randomly assigned in a double-blind manner either an aerosol-containing flunisolide dissolved in vehicle (a mixture of polyethylene glycol and propylene glycol) or vehicle alone. Flunisolide was sprayed as a 0.025% solution two times in each nostril twice a day. Forty-eight patients completed the study. Three patients dropped out for reasons unrelated to flunisolide usage. On the basis of physician interviews and daily symptom dairy scores, patients receiving flunisolide showed significant improvement of hay fever symptoms when compared to their counterparts receiving vehicle. No systemic steroid side effects were observed. Morning plasma cortisol levels measured prio to and after 3 wk of flunisolide therapy showed no significant difference between the treatment groups. Adverse local effects were minor and were noted less frequently with flunisolide than with vehicle. Flunisolide's topical efficacy and lack of adrenal suppression provide distinct advantages over other steroid preparations available in the United States for treatment of seasonal allergic rhinitis.