Faculty Bibliography

BACKGROUND: Intranasal corticosteroids and nonsedating antihistamines are the drug classes most often prescribed to treat allergic rhinitis (AR). Treatment guidelines recommend a combination of these agents for moderate-to-severe AR. However, clinical studies have found that combining an antihistamine with an intranasal corticosteroid provides few or no advantages over monotherapy with an intranasal corticosteroid. OBJECTIVE: To compare the efficacy of mometasone furoate nasal spray (NS) plus loratadine with that of monotherapy with the individual agents in patients 12 years and older with at least a 2-year history of seasonal AR. METHODS: In a multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study, 702 patients were randomized to receive mometasone furoate NS, 200 microg, plus loratadine, 10 mg (n = 169); mometasone furoate NS, 200 microg (n = 176); loratadine, 10 mg (n = 181); or placebo (n = 176) once daily for 15 days. Primary efficacy variables were total nasal symptom score (TNSS) and total symptom score (TSS) as recorded on diary cards. RESULTS: No statistically significant differences were observed between mometasone furoate NS plus loratadine and mometasone furoate NS monotherapy for the primary efficacy variables. For TNSS and TSS, all 3 active drug therapies were more effective than placebo (P < or = .02). Both mometasone furoate NS treatment regimens were more effective than loratadine or placebo for TNSS (P < .01 for both) and TSS (P < or = .03 for both), whereas loratadine was more effective than placebo for TNSS only (P = .02). CONCLUSIONS: Combination therapy with mometasone furoate NS and loratadine provided benefits similar to monotherapy with mometasone furoate NS for the symptoms of seasonal AR. Therefore, mometasone furoate NS monotherapy was shown to be an effective treatment for seasonal AR.

BACKGROUND: Burdensome symptoms of allergic rhinitis (AR) include nasal and ocular symptoms such as itching, tearing and redness. Intranasal corticosteroids are efficacious in the treatment of nasal symptoms of AR. OBJECTIVE: It was the aim of this study to determine the efficacy of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) in relieving ocular symptoms associated with seasonal AR (SAR). METHODS: Ocular symptom data were analyzed for subjects >or=12 years of age, randomized to MFNS 200 mug q.d. (n = 176) or placebo (n = 177) in a placebo-controlled, double-blind clinical trial. Post hoc efficacy analysis assessed the mean change from baseline in subject-reported total ocular symptom scores (TOSS) averaged over the treatment period. RESULTS: Mean baseline TOSS was 4.91 for the MFNS group and comparable (5.05) for the placebo group - combined average for individual symptoms such as itching, tearing and redness ranged from 0 (no symptoms) to 9 (all symptoms, severe). Mean change from baseline in TOSS averaged over days 1-15 was -1.42 for the MFNS group and -0.94 for the placebo group (p = 0.02), for an observed treatment difference of 0.49 (statistical data rounded to 2 decimal positions). Improvement in individual symptoms (eye itching, tearing and redness) contributed to this treatment effect; the greatest improvement occurred with tearing, which decreased -0.52 from the baseline score 1.59 in the MFNS group and -0.31 from 1.67 in those receiving placebo (p < 0.01), for an observed treatment difference of 0.21. Treatment with MFNS was safe and well tolerated. CONCLUSION: MFNS is effective in reducing ocular symptoms of SAR, in addition to its established efficacy in reducing nasal symptoms of SAR.

Flunisolide hydrofluoroalkane (HFA) has efficacy equivalent to that of flunisolide chlorofluorocarbon (CFC) at one third the dose of the CFC formulation, a reduction from 250 microg/puff for flunisolide CFC to 85 microg/puff for flunisolide HFA. Flunisolide HFA delivers a smaller particle size (1.2 microm) in solution, resulting in improved lung deposition as compared with flunisolide CFC (3.8 microm), which is delivered in suspension. An added built-in spacer has reduced oropharyngeal deposition that may result in fewer adverse events and make it easier to use. The objective of this study was to compare the year-long safety of flunisolide HFA (daily dosage 340 microg) with that of CFC beclomethasone dipropionate (BDP) (daily dosage 336 microg) and cromolyn sodium (daily dosage 6,400 microg) in children 4-11 years old with mild-to-moderate asthma. The effects of these drugs on linear growth and growth velocity were also compared. The study was a 1-year open-label, parallel-group trial. Changes in physical examinations (including growth), adverse events, vital signs, electrocardiograms, cosyntropin stimulation tests, mouth and throat cultures for Candida albicans, and laboratory findings were analyzed. Patients 4-5 years old received flunisolide HFA only. In total, 235 children were evaluated (152 receiving flunisolide HFA, 39 BDP, and 44 cromolyn). The incidence of adverse events was comparable among treatment groups; most were mild or moderate and considered unrelated to treatment. Among patients 6-11 years old, mean changes from baseline height at week 52 were 6.2 cm for the flunisolide HFA and cromolyn groups and 5.1 cm for the BDP group. Thus growth in children receiving flunisolide HFA was unaffected by 1 year of treatment. Changes from baseline in other parameters, including response to cosyntropin stimulation, were insignificant and similar among the 3 treatment groups. At the dosages studied, and following 1 year of treatment, flunisolide HFA with its small particle size and built-in spacer is safe and well tolerated in children 4-11 years old. There are no adverse effects associated with hypothalamic pituitary axis (HPA) function of flunisolide HFA, including linear growth in children 6-11 years old when compared with BDP and cromolyn sodium.