fluocortin-butyl-ester and Rhinitis--Allergic--Perennial

The effect of fluocortin butylester (FCB) in the topical treatment of perennial rhinitis was investigated in a double-blind study using a cross-over technique. The daily dose was 4 mg. Of the 30 patients who completed the trial, 26 had either allergy or nasal eosinophilia. 20 of the 30 patients preferred FCB to placebo. Moreover, there was a positive, but not statistically significant, therapeutic effect according to the patient score cards (0.1 less than p less than 0.2). In other words, the results are positive, but not definite. It is concluded that possibly the dose ought to be increased to obtain a more reliable effect.

Topics: Administration, Inhalation; Adult; Clinical Trials as Topic; Double-Blind Method; Female; Fluocortolone; Humans; Male; Middle Aged; Rhinitis, Allergic, Perennial

Fluocortin butyl (FCB) is a newly developed corticosteroid drug with no detectable systemic corticosteroid activity when it is used topically. Previous studies have demonstrated the therapeutic efficacy of FCB applied topically to the nasal mucosa three to four times a day for perennial rhinitis. The therapeutic efficacy of FCB used only twice daily, with total daily dosages similar to those previously found to be effective when these were applied more frequently, was studied in a multicenter, double-blind, placebo-controlled trial. This was a 4-week study with a 1-week observation (baseline) period and a 3-week period during which the response to three dosage regimens (2 mg per day, 4 mg per day, and 8 mg per day) of FCB and placebo were compared to baseline observations of rhinitis. Two hundred thirty-five patients from six centers were studied. Patients had perennial rhinitis of allergic, nonallergic, or combined etiology. Patients who received FCB exhibited significant amelioration of signs and symptoms of rhinitis as assessed by patients and physicians and had a greater reduction in the use of concomitant antihistamine and/or decongestant therapy compared to placebo-treated patients. Relief tended to occur early and was progressive during the 3 wk of therapy. There were no significant differences in response between the various dosages of FCB used. Side effects were minimal and insignificant and did not differ between FCB-treated and placebo-treated patients. FCB appears to be an effective well-tolerated topical steroid useful in the treatment of perennial rhinitis.

Topics: Adolescent; Adult; Chlorpheniramine; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Ephedrine; Fluocortolone; Humans; Middle Aged; Rhinitis, Allergic, Perennial

The measurement of nasal patency by anterior rhinometry is a potentially useful tool in evaluating patients with various forms of rhinitis. This study measured both nasal air flow by anterior rhinometry and symptom/sign scores in 49 children with perennial allergic rhinitis. We found that anterior rhinometry in children is (1) a simple, rapid procedure, (2) well accepted by the pediatric patient, and (3) a valid technique for objectively assessing and quantifying the somewhat subjective parameters that physicians traditionally follow for allergic rhinitis.

Topics: Administration, Intranasal; Adolescent; Child; Clinical Trials as Topic; Double-Blind Method; Female; Fluocortolone; Humans; Male; Manometry; Nasal Mucosa; Pulmonary Ventilation; Rhinitis, Allergic, Perennial; Transducers, Pressure

Fluocortin butyl (FCB) is a newly synthesized corticosteroid with a high ratio of topical to systemic activity. FCB was studied in a multi-center, double-blind, placebo-controlled trial of therapy of perennial rhinitis. The study was conducted between January and May 1981. Patients evaluated suffered from either chronic allergic or chronic nonallergic rhinitis or both. A total of 306 patients from 16 investigative centers were evaluated by comparing FCB to placebo. Three separate dosage regimens were employed. Patients received a total daily dose of 2, 4, or 8 mg. FCB was found to be an effective therapeutic agent. It reduced symptoms of nasal congestion, rhinorrhea, postnasal drainage, and sneezing. It also markedly reduced the use of concomitant medications (chlorpheniramine maleate and/or pseudoephedrine). Relief of symptoms was noted as early as the first week of therapy, and the degree of improvement increased progressively during the study. There was little difference between the relief produced by the 4 mg and 8 mg regimens. Both of these were superior to the 2 mg regimen. The drug was well tolerated; no significant side effects were noted.

Topics: Adult; Chlorpheniramine; Clinical Trials as Topic; Double-Blind Method; Ephedrine; Female; Fluocortolone; Humans; Male; Placebos; Rhinitis, Allergic, Perennial

Fluocortin butyl (FCB) is a recently developed topical intranasal corticosteroid that is inhaled as a powder and has been demonstrated to be well tolerated and to improve symptoms and signs of perennial rhinitis in previous short-term studies. This multicenter, open-label study evaluated the efficacy and safety of FCB during a 12-month treatment period in patients with perennial rhinitis. Treatment was initiated with one inhalation of FCB in each nostril three times a day (total dosage, 3 mg/day). In subsequent months, one third of the patients was maintained at the dosage of 3 mg/day, one third at a lower dosage of 2 mg/day, and the remaining one third of the patients at a larger dosage of 4 to 8 mg/day. Of 109 patients enrolled in the study, 90 patients (82.6%) completed all 12 months of treatment. Symptom and sign scores decreased significantly (p less than 0.001) at the 2-month evaluation compared to scores at baseline, and the improvement was maintained throughout the 12-month study period. After 12 months, greater than 80% of the patients had substantial control of symptoms. Specimens of nasal biopsies, performed at the beginning and end of treatment, revealed a decrease in eosinophils and other cellular infiltrates, a slight tendency of an increase in mast cell counts, and a trend toward normalization of the nasal mucosa. There were few adverse effects. Mean plasma cortisol levels were normal before and after corticotropin stimulation at baseline and after 12 months of FCB therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Intranasal; Adolescent; Adrenal Cortex; Adult; Aged; Biopsy; Child; Female; Fluocortolone; Humans; Male; Middle Aged; Nasal Mucosa; Rhinitis, Allergic, Perennial