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Biomedical subjects

Sheldon L Spector

Publications and source records attributed to Sheldon L Spector.

12 recordsLinked to original sources
PubMed2005

Once-daily fexofenadine treatment for chronic idiopathic urticaria: a multicenter, randomized, double-blind, placebo-controlled study.

BACKGROUND: Chronic idiopathic urticaria (CIU) can have a profound effect on patients' health and quality of life. OBJECTIVE: To evaluate the efficacy and safety of once-daily dosing of fexofenadine hydrochloride, 180 mg, on CIU. METHODS: This randomized, double-blind, parallel-group, placebo-controlled study consisted of a placebo run-in period followed by a 4-week treatment period. Patients 12 years and older with active CIU were randomized 2:1 to receive once-daily fexofenadine, 180 mg, or placebo. The primary end points were change from baseline in mean daily number of wheals (MNW score) and mean daily severity of pruritus during treatment. Secondary efficacy measures included modified total symptom scores and MNW and pruritus severity scores evaluated weekly and instantaneously at trough drug levels. RESULTS: Patients administered fexofenadine (n = 163) experienced significantly greater improvements in MNW and pruritus severity scores compared with the placebo group (n = 92) (P < .001 for both). Similarly, throughout treatment and at each individual week, the mean reductions in modified total symptom scores were significantly greater in the fexofenadine group (P < or = .005 for all comparisons vs placebo). The mean reductions in instantaneous MNW and pruritus severity scores were greater in patients in the fexofenadine group than in those who received placebo (MNW score: P = .015; pruritus severity score: P < .001). There were no significant differences in the frequency of treatment-emergent adverse events between the 2 treatment groups. CONCLUSIONS: A once-daily dose of fexofenadine hydrochloride, 180 mg, offered effective, well-tolerated relief for the management of CIU.

Adolescent↗
PubMed2004

Efficacy and safety of oral telithromycin once daily for 5 days versus moxifloxacin once daily for 10 days in the treatment of acute bacterial rhinosinusitis.

OBJECTIVE: To compare the clinical and bacteriologic efficacy and safety of short-duration treatment with telithromycin given for 5 days with moxifloxacin given for 10 days in adults with acute bacterial rhinosinusitis (ABRS). STUDY DESIGN: In this prospective, double-blind, parallel-group, randomized, multicenter study, adult patients (N = 349) with ABRS were randomized to oral telithromycin (800 mg once daily for 5 days) or to oral moxifloxacin (400 mg once daily for 10 days) and followed for 31 to 36 days. Clinical outcome was determined by the investigator at the posttherapy/test of cure (TOC) visit. Bacteriologic outcome was determined by comparing cultures taken at the pretreatment visit with cultures obtained at the posttherapy/TOC visit. The primary objective was to demonstrate equivalence of clinical cure rates in the per-protocol population between treatment groups at the posttherapy/TOC visit. RESULTS: Clinical success at TOC (primary endpoint) was achieved in 87.4% of patients in the telithromycin group compared with 86.9% for moxifloxacin (per-protocol patients; 0.5% difference between treatment groups; 95% confidence interval [CI], -8.1, 9.2; P = 0.8930). The bacteriologic success rates were 94.1% and 93.9%, respectively (0.2% difference between treatment groups; 95% CI, -14.2, 14.5; P = 0.9734). Overall treatment-emergent adverse events for both drugs (mostly gastrointestinal) were mild to moderate in intensity. CONCLUSION AND SIGNIFICANCE: The clinical and bacteriologic efficacy of telithromycin 800 mg once daily for 5 days was equivalent to that of moxifloxacin 400 mg once daily for 10 days, establishing telithromycin as an important treatment option for ABRS.

Acute Disease↗
PubMed2004

Effectiveness of montelukast in the treatment of cough variant asthma.

BACKGROUND: Antileukotriene agents have been shown to be beneficial in chronic asthma. Although patients with cough variant asthma have cough with minimal wheezing and dyspnea, airway hyperresponsiveness from chronic inflammation is believed to be the underlying mechanism. OBJECTIVE: To evaluate the effectiveness of montelukast, a leukotriene receptor antagonist, in the treatment of cough variant asthma. METHODS: Fourteen patients with cough variant asthma participated in a randomized, double-blind, placebo-controlled trial with a 7- to 10-day baseline period and a 4-week treatment period with montelukast, 10 mg, or placebo daily. Inclusion criteria were (1) chronic cough with a duration of at least 4 weeks with minimal or no wheezing or dyspnea and (2) forced expiratory volume in 1 second of 50% to 85% of predicted and reversibility of 12% with use of an inhaled beta-agonist or forced expiratory volume in 1 second greater than 85% and positive methacholine challenge results. Patients fulfilled the minimum criteria for cough frequency and symptom scores for randomization. RESULTS: Eight patients received montelukast and 6 received placebo. The primary efficacy variable, mean percentage change from baseline in cough frequency, was significantly improved by the second week, and by the fourth week the mean percentage change from baseline was 75.7% for the treatment group and 20.7% for the placebo group. CONCLUSIONS: The leukotriene receptor antagonist montelukast seems to be effective in the treatment of cough variant asthma. Larger studies are recommended to confirm this effect.

Acetates↗
PubMed2004

Lysozyme levels in the nasal secretions of patients with perennial allergic rhinitis and recurrent sinusitis.

BACKGROUND: The association of perennial allergic rhinitis (PAR) with recurrent sinusitis (RS) is well recognized. Anatomic abnormalities at the osteomeatal complex or ciliary dysfunction may play a significant role in some patients. However, for most patients with allergy, the determinants of RS are unknown. OBJECTIVE: To determine whether altered concentrations of antimicrobial peptides and proteins, such as lysozyme, lactoferrin, human beta-defensin-2 (HBD-2), and human neutrophil peptides 1 to 3 (HNP-1 to 3), contribute to the development of RS in patients with PAR. METHODS: Nasal secretions were collected by vacuum aspiration from 15 individuals with PAR+RS, 16 with PAR alone, and 16 controls. Lysozyme and lactoferrin levels were determined in nasal secretions by using quantitative enzyme-linked immunosorbent assay, and HBD-2 and HNP-1 to 3 levels were determined in nasal secretions by using semiquantitative Western blot analysis. Eosinophil-derived neurotoxin (EDN) levels were measured by using enzyme-linked immunosorbent assay as a marker of nasal eosinophilia in all 3 groups. RESULTS: Levels of EDN were elevated significantly in patients with PAR+RS compared with controls. Lysozyme levels were decreased significantly in patients with PAR+RS compared with PAR alone or controls. Mean lysozyme levels were significantly lower in patients with EDN levels greater than 1,000 ng/mL vs those with levels of 1,000 ng/mL or less in the PAR+RS group. There were no statistically significant differences in lactoferrin, HBD-2, and HNP-1 to 3 levels among the 3 groups. CONCLUSIONS: The presence of eosinophils and their products and reduced lysozyme concentrations may be critical factors that predispose the airways of patients with PAR to RS.

Adult↗
PubMed2003

Provocation studies in the diagnosis of occupational asthma.

Specific and nonspecific provocation studies, although not always essential for diagnosing OA, help confirm the diagnosis and identify the offending agent. Nonspecific bronchial challenge testing is used to detect airway hyperresponsiveness and to clarify the nature of the patient's symptoms. Pharmacologic bronchoconstrictor agents (eg, methacholine, histamine) most commonly are used for the challenge, but nonisotonic aerosols, exercise and hyperventilation also can show airway hyperresponsiveness. Nonspecific challenges usually are done in the laboratory, but can be done at the workplace if emergency equipment is available. A comparison of results obtained at and away from the workplace (at least 1 week apart) may be helpful in diagnosing OA. Specific bronchial challenge testing is considered the gold standard for OA diagnosis. It can be crucial in helping physicians, employers, and employees make decisions about continued employment, compensation, career changes, and treatment. Testing can pinpoint new industrial agents that cause OA, enabling dissemination of information on its hazards to the public and within the industry. The nature of the agent determines the type of protocol that is used for testing. Agents can be in the form of dusts, powders, aerosols, vapors gases, and animal dander. Exposure can be as simple as having patients simulate their work activities, or as complicated as using special challenge chambers with controlled environments and precise delivery of agents. Performing control challenges with a component that is separate from the test agent is essential to avoid false-positive results. The timing, duration, and dosing of exposure depend on the type of reaction that has been experienced previously, the nature of the agent, and the patient's baseline airway hyperresponsiveness. Serial spirometry and observation often are done for up to 8 hours to monitor early and late reactions. SBC testing should be performed in the proper medical setting in which emergency equipment available and should be administered only by healthcare personnel who are trained and experienced in the procedures. Safety of the patient is the primary consideration.

Asthma↗
PubMed2003

Diet and asthma: has the role of dietary lipids been overlooked in the management of asthma?

OBJECTIVE: This article discusses the role of diet in the management of asthma. Readers will gain an understanding of how evolution of the western diet has contributed to increased asthma prevalence and how dietary modification that includes management of dietary lipids may reduce symptoms of asthma. DATA SOURCES: Relevant studies published in English were reviewed. STUDY SELECTION: Medline search to identify peer-reviewed abstracts and journal articles. RESULTS: Asthma and obesity, which often occur together, have increased in prevalence in recent years. Studies suggest adaption of a western diet has not only contributed to obesity, but that increased intake of specific nutrients can cause changes in the frequency and severity of asthma. Increased asthma prevalence has also been proposed to arise from increased exposure to diesel particles or lack of exposure to infectious agents or endotoxins during childhood, generating a biased Th2 immune response, and increased cytokine and leukotriene production. Antagonists directed against these pro-inflammatory mediators include anticytokines and antileukotrienes. A reduction in the levels of inflammatory mediators associated with asthma has also been seen with dietary interventions, such as the administration of oils containing gamma-linolenic acid and eicosapentaenoic acid. CONCLUSIONS: Evidence suggests elevated body mass index and dietary patterns, especially intake of dietary lipids, contribute to symptoms of asthma. Dietary modification may help patients manage their asthma as well as contribute to their overall health.

Adolescent↗
PubMed2003

Efficacy and safety of budesonide inhalation powder (Pulmicort Turbuhaler) during 52 weeks of treatment in adults and children with persistent asthma.

BACKGROUND: Inhaled corticosteroids are the agents of choice for treating persistent asthma. OBJECTIVE: To evaluate the long-term efficacy and safety of budesonide inhalation powder (Pulmicort Turbuhaler) in patients with mild to severe persistent asthma. METHODS: Patients (n=1133) received open-label budesonide (dose range, 100-800 microg b.i.d.) for 52 weeks following 2 weeks to 5 months of treatment in one of four double-blind, placebo-controlled studies. Patients, identified before the double-blind studies, included adults (n=249) not receiving corticosteroids, adults (n=384) and children (n=356) previously maintained on inhaled corticosteroids, and adults (n=144) previously maintained on oral corticosteroids. RESULTS: Mean forced expiratory volume in 1 sec was 68.2% of predicted normal (n=1133) at baseline (mean from two visits before randomization), 74.4% (n=1132) at the end of double-blind treatment, 81.3% (n=971) at week 52, and 80.1% (n=1125) at last observation (including patients who discontinued early). Sixty-four patients maintained on oral corticosteroids before double-blind treatment entered the open-label study off oral corticosteroids, 58 of whom (91%) remained oral corticosteroid-free throughout the study. There was no evidence of basal or cosyntropin-stimulated hypothalamic-pituitary-adrenal axis function suppression, and the most commonly occurring adverse events were respiratory infection, sinusitis, and pharyngitis. CONCLUSIONS: During this 52-week, open-label study, budesonide maintained the improved pulmonary function and decreased oral corticosteroid use observed during previous double-blind treatment and was well tolerated, supporting its long-term use in adults and children with mild to severe persistent asthma.

Administration, Inhalation↗
PubMed2002

Exercise-induced asthma: diagnosis and management.

OBJECTIVE: To review the diagnosis and management of exercise-induced asthma (EIA). DATA SOURCES: Computer-assisted literature searches on MEDLINE for articles, abstracts, and other relevant data on exercise-induced asthma STUDY SELECTION: Published articles, abstracts, and conference proceedings were selected. RESULTS: EIA is seen in 40 to 90% of asthmatic patients. Exercise can be the sole trigger or be one of multiple triggers of asthma exacerbations. A good history and physical examination can diagnose most cases of EIA. Spirometry can confirm the diagnosis. Exercise testing may be necessary in certain cases. Prevention through both pharmacologic and nonpharmacologic measures is the key to EIA management. Inhaled beta-agonists remain the medications of choice for EIA prophylaxis. Inhaled cromolyn and antileukotrienes are alternatives. Good long-term control of asthma with anti-inflammatory medications such as inhaled steroids will also decrease the incidence of EIA. CONCLUSIONS: Early diagnosis and proper preventive and maintenance therapy can reduce episodes of EIA and enable patients to continue to engage in sports and lead an active life.

Adrenergic beta-Agonists↗