Comparative study of extended release albuterol sulfate and long-acting inhaled salmeterol xinafoate in the treatment of nocturnal asthma.

BACKGROUND: Nocturnal worsening of asthma is a common problem in asthma and is associated with increased morbidity and mortality. Long acting beta-2 agonists are considered long-term symptom control medications, especially for nocturnal symptoms. OBJECTIVE: To compare efficacy of an extended release oral beta-2 agonist, albuterol sulfate (Volmax), to a long-acting inhaled agent, salmeterol (Serevent) in the treatment of nocturnal asthma. METHODS: This was a multicenter double-blind, double-dummy, randomized, crossover design with a 1-week baseline period and two 3-week treatment periods separated by a 7 to 9-day washout. An optional 2-week, open-label phase was conducted to evaluate patient preference. RESULTS: A total of 46 patients were included in the efficacy analysis. For the primary outcome variable of morning peak expiratory flow, there were similar and significant improvements over the 3-week treatment period for both medications compared with baseline (P < .001). Similar improvements were seen in the overnight change in PEF values (P < .001). The morning and overnight changes in FEV1 were not significantly different between treatment arms (P > .05). There were significant improvements in both treatment periods in regard to the percentage of nights without awakenings (baseline 53.6+/-5.3%), extended release albuterol 83.3+/-3.0% (P < .001), and salmeterol 88.8+/-2.4%. The percentage of patients who had no awakenings during treatment did not differ significantly for the two medications. Both treatments also resulted in a decrease in the use of rescue albuterol (extended release 2.66+/-0.35 puffs per day, salmeterol 1.85+/-0.29) from baseline (4.57+/-0.41, P < .001). There was a significant difference between groups (P = .001). The reasons why patients preferred one medication over the other varied. CONCLUSION: Both extended release albuterol tablets and inhaled salmeterol resulted in similar bronchodilation and good control of nocturnal asthma symptoms.

Long-term safety and efficacy of triamcinolone acetonide aqueous nasal spray for the treatment of perennial allergic rhinitis.

This 12-month, multicenter, open-label study to assess the long-term safety and efficacy of triamcinolone acetonide (TAA) aqueous nasal spray for perennial allergic rhinitis (PAR) symptom relief was a continuation of a 4-week, double-blind study. Patients who received TAA Aqueous (220 micrograms/day) during the 4-week, double-blind study continued with the same treatment for the open label study; those randomized to placebo during the 4-week, double-blind study received TAA Aqueous (220 micrograms/day) for the open-label study. Dose reduction to 110 micrograms/day was allowed if it was felt that symptom relief would be maintained. Safety was assessed by daily diary entries and clinical laboratory results. Long-term efficacy was assessed by visual analog scale (VAS). Of the 172 patients who began the open-label study, 94.2 percent completed 3 months of treatment, 83.6 percent completed 6 months, and 62 percent completed 12 months. PAR symptom relief improved progressively throughout the study. Adverse events were generally mild or moderate and consistent with long-term use and winter symptoms. The most common adverse events were pharyngitis (32 percent of patients), rhinitis (28.5 percent), headache (22.1 percent), and epistaxis (18 percent). Adverse events related to the local effects of the study medication were similar to those observed in long-term studies with TAA aerosol. The aqueous nasal spray formulation of triamcinolone acetonide was well tolerated and continued to relieve nasal symptoms with long-term use in adolescent and adult patients with PAR.

Minor symptoms are not predictive of elevated theophylline levels in adults on chronic therapy.

BACKGROUND: Theophylline toxicity is associated with significant morbidity and mortality. While a relationship of the serum theophylline level to symptoms associated with toxicity has been described in acutely intoxicated or elderly patients, this relationship may not be valid in younger patients receiving chronic theophylline therapy. OBJECTIVE: This study was designed to define the predictive value and prevalence of minor symptoms of theophylline toxicity in ambulatory asthmatic adults receiving chronic theophylline therapy with elevated serum theophylline levels. METHODS: We conducted a retrospective study to determine the prevalence of symptoms in patients with elevated theophylline levels ( > 20 mg/L or 110 mumol/L). A prospective study was performed to ascertain the sensitivity, specificity, and predictive value of symptoms as an indication of elevated the theophylline level. In addition, we describe a patient who had a seizure in association with an elevated theophylline level in the absence of any preceding symptom of theophylline toxicity. RESULTS: We reviewed the result of 483 theophylline measurements in 450 asthmatic patients. In 46 instances the theophylline levels was > 20 mg/L. Only three of these patients were symptomatic. Ninety patients were prospectively studies with a total of 111 theophylline measurements of which 13 exceeded 20 mg/L. None of the symptoms (ie, nausea or gastrointestinal upset; headache or palpitations, irregular heart beat, tremor, or shakiness) was a sensitive predictor of an elevated theophylline level. CONCLUSIONS: Elevation of the theophylline level is frequently associated with lack of symptoms in young ambulatory asthmatic adults receiving chronic theophylline therapy. The question of whether cardiac or neurologic electrophysiologic abnormalities might exist in the absence of symptoms is an issue that needs to be addressed. Clinicians should continue to monitor serum levels on a regular basis and prescribe this drug conservatively.

Triamcinolone acetonide aqueous nasal spray for the treatment of patients with perennial allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled study.

In this multicenter, randomized, double-blind, placebo-controlled study, 178 patients with symptoms of perennial allergic rhinitis (PAR) were treated with either triamcinolone acetonide (TAA) Aqueous nasal spray (220 micrograms once daily) or placebo for 4 weeks. Symptoms of PAR (nasal stuffiness, nasal discharge, sneezing, nasal index, and nasal itching) were evaluated throughout the treatment period through the use of patient diaries. In addition, both patients and physicians completed independent global evaluations of treatment efficacy at the conclusion of the study. TAA Aqueous provided clinically and statistically (P < or = 0.05) greater improvements in nasal stuffiness, sneezing, nasal index, and nasal itching over the 4-week study period than did placebo. Significant improvements in sneezing (P = 0.022) were observed as early as the first day (within 12 to 16 hours based on treatment in the morning and assessment of symptoms at bedtime), and in the nasal index (P = 0.009) by the third day after treatment with TAA Aqueous. Patients' and physicians' global evaluations of overall efficacy were concordant: 65% of patients rated their nasal symptoms greatly or somewhat improved with TAA Aqueous compared with 48% in the placebo group; physicians rated 66% of patients as having greatly or somewhat improved symptoms with the study drug compared with 48% of patients who received placebo. Adverse events were mild and the incidences were comparable for both groups; no significant changes in vital signs or clinical laboratory parameters were observed. This study demonstrated that TAA Aqueous administered once daily was well tolerated and provided relief of PAR symptoms in adults and adolescents.

Spontaneous cerebrospinal fluid rhinorrhea with associated sinusitis and allergic rhinitis.

The entity of spontaneous cerebrospinal fluid rhinorrhea is a rare condition that presents a special challenge to the practicing allergist. Delayed diagnosis can be associated with significant morbidity and mortality. We describe two cases of this condition occurring in association with allergic rhinitis and sinusitis. The presentation and management of these cases is described. A high index of suspicion for this condition should be maintained in all patients who present with profuse and often unilateral rhinorrhea.

Fasciitis with eosinophilia: a case report.

The history, laboratory findings, and treatment of a patient with fasciitis and eosinophilia are presented. A review of approximately ninety (90) cases in the literature suggests that this inflammatory process is distinct from scleroderma.