ABSTRACT
BACKGROUND: Proinflammatory mediators such as the cysteinyl leukotrienes are important in the pathophysiology of allergic rhinitis. This study evaluated the efficacy and tolerability of montelukast, a cysteinyl leukotriene receptor antagonist, given once daily in the morning for treatment of seasonal (fall) allergic rhinitis for 4 weeks. METHODS: This was a randomized, double-blind trial with a placebo run-in and a 4-week treatment period. Patients (n = 1079) with a history of allergic rhinitis and a positive skin test to seasonal pollen allergens were assigned to placebo, montelukast 10 mg, or loratadine 10 mg. Symptoms were assessed with a daily diary. RESULTS: Montelukast was more effective than placebo in improving scores for the primary endpoint of daytime nasal symptoms (P = 0.003) and the secondary endpoints of night-time, composite, and daytime eye symptoms, patient's and physician's global evaluations of allergic rhinitis, and rhinoconjunctivitis quality-of-life (P = 0.006). The positive control loratadine also improved scores for the primary endpoint (P = 0.001) and the majority of the secondary endpoints (P < 0.03). When analyzed by week, the treatment effect of montelukast was more persistent than loratadine over all 4 weeks of treatment. CONCLUSION: Montelukast provided effective relief of seasonal allergic rhinitis symptoms when given once daily in the morning, showed significant and sustained improvement in symptoms of allergic rhinitis over 4 weeks of treatment, and was well-tolerated.
Subject(s)
Acetates/therapeutic use , Leukotriene Antagonists/therapeutic use , Quinolines/therapeutic use , Rhinitis, Allergic, Seasonal/drug therapy , Adolescent , Adult , Aged , Anti-Allergic Agents/therapeutic use , Cyclopropanes , Double-Blind Method , Female , Humans , Loratadine/therapeutic use , Male , Middle Aged , Sulfides , Treatment OutcomeABSTRACT
BACKGROUND: Mometasone furoate nasal spray (MFNS, NASONEX ), is a new synthetic corticosteroid with considerable efficacy in the treatment of seasonal and perennial rhinitis and less than 0.1% systemic absorption. This study was designed to evaluate the time of onset of action of MFNS. The subjects were evaluated over the course of 2 weeks during the spring allergy season. METHODS: The effects of MFNS 200 microg given once daily for 2 weeks were evaluated in a randomized, multicenter, double-blind, placebo-controlled study in 201 patients with seasonal allergic rhinitis. Clinically significant onset of action was assessed prospectively by special patient diary cards kept during the first 3 days of treatment. RESULTS: By 12 h after initial dosage (the earliest evaluation), 28% of patients in the MFNS group experienced clinically significant relief, compared with 13% of those given placebo (P = 0.01). Median time to at least moderate symptom relief in patients who received MFNS was 35.9 h, compared with more than 72 h in patients given placebo (P<0.01). By 72 h, 64% of the patients receiving MFNS experienced at least moderate relief, compared with 40% of those treated with placebo (P<0.01). Both patient and physician ratings of symptom severity, response to treatment, and overall condition of rhinitis indicated significant (P<0.01) superiority of MFNS over placebo. MFNS was well tolerated, with adverse events comparable to placebo. CONCLUSIONS: MFNS provided rapid onset of clinically significant symptom relief in patients with seasonal allergic rhinitis.
Subject(s)
Anti-Allergic Agents/administration & dosage , Pregnadienediols/administration & dosage , Rhinitis, Allergic, Seasonal/drug therapy , Administration, Intranasal , Adolescent , Adult , Child , Double-Blind Method , Female , Humans , Male , Middle Aged , Mometasone Furoate , Self Care , Time FactorsABSTRACT
BACKGROUND: National and international guidelines recommend the use of inhaled antiinflammatory medications in patients with all but the mildest forms of asthma. Twice daily dosing may increase compliance with therapy. OBJECTIVE: We sought to evaluate the safety and efficacy of 400 microg twice daily triamcinolone acetonide (TAA) compared with placebo in adult patients with mild-to-moderate asthma who were poorly controlled by beta2-agonist therapy. METHODS: We performed a multicenter, randomized, double-blind, placebo-controlled study, including a screening visit, a 7- to 21-day pretreatment baseline phase, and a 6-week double-blind treatment phase. Efficacy was measured by weekly spirometry and daily diary recordings of peak flow rates, asthma symptom scores, and albuterol use. Eligible patients used albuterol four or more times per day, had total asthma symptom scores of 15 or greater (possible total, 60) over 5 of 7 baseline days, and had FEV1 measurements of 60% of predicted value or greater. RESULTS: One hundred twenty-one patients were randomized to treatment. TAA was superior to placebo for all efficacy measures, with significant improvements in asthma symptoms, albuterol use, morning and evening peak flow rates, and forced vital capacity evident at Treatment Week 1. Significant improvements in other pulmonary function measurements were observed after 2 or more weeks. All efficacy variables improved progressively throughout the study. CONCLUSIONS: Twice daily TAA (400 microg) decreased asthma symptoms and improved lung function in patients with mild-to-moderate asthma compared with placebo. Therapeutic benefit was evident within 1 week and increased throughout treatment.
Subject(s)
Anti-Inflammatory Agents/therapeutic use , Asthma/drug therapy , Triamcinolone Acetonide/therapeutic use , Adult , Albuterol/therapeutic use , Asthma/physiopathology , Double-Blind Method , Drug Administration Schedule , Female , Humans , Lung/physiopathology , Male , Maximal Expiratory Flow Rate , Middle Aged , Triamcinolone Acetonide/administration & dosageABSTRACT
Between 15 and 30 million Americans have allergic rhinitis. Costs of diminished job and school performance extend beyond the financial burden of treatment, taking their toll in worker productivity and school absences. Therapeutic approaches include allergen avoidance, pharmaceuticals, and allergy immunotherapy. Among the pharmaceutical agents, decongestants, anti-inflammatory drugs, and antihistamines relieve allergic rhinitis symptoms. Often, decongestants are prescribed along with antihistamines to provide maximum relief. Anti-inflammatory agents such as cromolyn sodium and topical corticosteroids are efficacious despite their delayed effect. However, allergic rhinitis is most frequently treated with antihistamines. Today's antihistamines have minimal sedative effects and cholinergic actions, are safe to use, and do not impair performance.
Subject(s)
Rhinitis, Allergic, Seasonal , Humans , Rhinitis, Allergic, Seasonal/diagnosis , Rhinitis, Allergic, Seasonal/economics , Rhinitis, Allergic, Seasonal/therapyABSTRACT
BACKGROUND: Few clinical trials have directly compared the efficacy of antihistamines with topical nasal corticosteroids. OBJECTIVE: The study was performed to compare the efficacy and safety of triamcinolone acetonide nasal spray at a dose of 110 micro g in each nostril once daily with 10 mg of oral astemizole once daily for the treatment of seasonal allergic rhinitis. METHODS: A multicenter, double-blind, parallel-group study was conducted in 239 patients who were randomized to receive either triamcinolone acetonide or astemizole. A 5-day, drug-free, lead-in period was followed by 4 weeks of double-blind treatment. One hundred four patients treated with triamcinolone acetonide and 105 patients treated with astemizole could be evaluated. RESULTS: Overall, triamcinolone acetonide was more effective than astemizole in reducing total nasal symptoms, nasal stuffiness, nasal itching, and sneezing (p = 0.01). Triamcinolone acetonide was superior to astemizole at weeks 1, 2, and 3 in reduction of the total nasal symptom score (p = 0.0401) and in reduction of nasal stuffiness (p = 0.05). Improvements in individual nasal symptoms (itching, postnasal drip, runny nose, and sneezing) were greater for triamcinolone acetonide at week 2 (p = 0.01). Ocular symptoms improved from baseline in both groups. When pollen counts were correlated to mean nasal rhinitis scores, the triamcinolone acetonide group showed continued improvement from week 1 to week 2 in nasal symptoms when pollen counts were at their highest. During the same period, patients treated with astemizole failed to show improvement from week 1 to week 2. This study demonstrated that once daily administration of triamcinolone acetonide was more effective than astemizole for controlling nasal symptoms of seasonal allergic rhinitis, especially during the peak pollination period.