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Biomedical subjects

E O Meltzer

Publications and source records attributed to E O Meltzer.

At least 37 records · Page 2Linked to original sources
PubMed1999

Comparison of ipratropium bromide 0.03% with beclomethasone dipropionate in the treatment of perennial rhinitis in children.

OBJECTIVE: To compare the safety and efficacy of ipratropium bromide 0.03% (IB) with beclomethasone dipropionate 0.042% (BDP) in the treatment of perennial rhinitis in children. METHODS: Thirty-three children with nonallergic perennial rhinitis (NAPR) and 113 with allergic perennial rhinitis (APR) were randomly assigned to either IB or BDP for 6 months in a single-blind, multicenter protocol in which the physician was blinded to treatment. At each visit, patients and physicians rated symptom control of rhinorrhea, nasal congestion, and sneezing. Patients also completed quality of life questionnaires at baseline and after 6 months of therapy. RESULTS: Both treatments showed a significant improvement in control of rhinorrhea, congestion, and sneezing compared with baseline over the 6 months of treatment (P < .05). Only for the control of sneezing was BDP consistently better than IB (P < .05). Among the patients given IB, 61% to 73% assessed the control of rhinorrhea as good or excellent on different study visit days, 43% to 60% similarly rated the control of nasal congestion, and 39% to 43% the control of sneezing. The results for BDP were 68% to 78% for the control of rhinorrhea, 55% to 72% for the control of nasal congestion, and 54% to 68% for the control of sneezing. Quality of life assessment documented that both drugs significantly reduced interference with daily activities and disturbance of mood due to rhinorrhea compared with baseline (P < .05). Both treatments were well tolerated with IB causing less nasal bleeding and irritation than BDP. CONCLUSIONS: Ipratropium bromide was safe and effective in controlling rhinorrhea and diminishing the interference by rhinorrhea in school attendance, concentration on school work, and sleep. Ipratropium bromide was as effective as BDP in the control of rhinorrhea and showed a relatively good effect on congestion. Patient and physician assessment favored BDP in the control of sneezing.

Adolescent↗
PubMed1999

Once-daily fexofenadine HCl improves quality of life and reduces work and activity impairment in patients with seasonal allergic rhinitis.

BACKGROUND: Fexofenadine HCl (Allegra, Telfast) is approved in the US for twice-daily dosing for treatment of seasonal allergic rhinitis. OBJECTIVE: To determine the effect of once-daily fexofenadine HCl on patient-reported quality of life and impairment at work, in the classroom, and in daily activities due to seasonal allergic rhinitis symptoms. METHODS: This placebo-controlled, double-blind, randomized study included patients aged 12 to 65 years with moderate-to-severe seasonal allergic rhinitis symptoms. Outcomes were assessed using self-administered questionnaires at baseline, week 1, and week 2. Outcome measures included change from baseline in: overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score; individual RQLQ domain scores; work, classroom, and daily activity impairment measured using the Work Productivity and Activity Impairment (WPAI) instrument; and ratings in 3 generic health domains from the SF-36 Health Survey. RESULTS: Intent to treat efficacy analyses included 845 patients from 40 sites. Patients receiving either 120 or 180 mg QD fexofenadine HCl reported significantly greater improvement (P < or = .006) in overall RQLQ score than patients receiving placebo. Similarly, both fexofenadine treatment groups reported significantly greater reductions in overall work impairment and daily activity impairment compared with the placebo group (P < or = .004). There was a trend for improvement in classroom impairment with fexofenadine treatment, although differences from placebo were not statistically significant. Generic health measures demonstrated fexofenadine HCl treatment had a positive effect on general health. CONCLUSION: Once-daily fexofenadine HCl, 120 or 180 mg, significantly improved patient-reported quality of life and reduced performance impairment in work and daily activities due to seasonal allergic rhinitis symptoms compared with placebo.

Activities of Daily Living↗
PubMed1999

Impact of cetirizine on the burden of allergic rhinitis.

OBJECTIVE: The goals of this article include the reporting of the epidemiology, economic and medical impact of allergic rhinitis. In addition, the pharmacology and clinical profile of the therapeutic agent cetirizine are reviewed. DATA SOURCES: A detailed literature search was conducted. References are limited to the English language and human subjects and tissues. Studies considered relevant and important over the past 20 years are highlighted. STUDY SELECTION: Prevalence and morbidity data were chosen from more recent assessments. Because cetirizine is a relatively new compound, studies from the past several years from peer-reviewed journals have been emphasized. RESULTS: Allergic rhinitis affects between 15% and 25% of the US general population. It shares common pathophysiologic mechanisms with conjunctivitis and asthma and predisposes to nasal infections, otitis media, sinusitis, nasal polyposis, and orthodontic malocclusions. Direct medical care costs amount to up to 3 billion dollars every year. In addition, the quality of life of affected individuals is substantially compromised. Cetirizine is a potent H1-receptor antagonist and has anti-inflammatory properties. It does not interact with concomitantly administered medications, has no cardiac adverse effects, and does not appear to be associated with teratogenicity. Impairment of CNS function is comparable to other low-sedating antihistamines at the recommended dose of 10 mg daily for adults. Its clinical efficacy for allergic respiratory diseases has been established in numerous trials. CONCLUSIONS: Allergic rhinitis causes considerable suffering. Cetirizine, with a fine risk-benefit ratio, can be a most valuable therapeutic option.

Anti-Allergic Agents↗
PubMed1999

A step approach to the clinical management of allergic rhinitis: prescription and over-the-counter therapeutic reference summary.

Allergic rhinitis is a debilitating condition. Successful clinical management requires patient education, allergen avoidance, and individualized pharmacotherapy. Immunotherapy may also be valuable for specific patients. With recent changes in the prescription of pharmacotherapies for allergic rhinitis symptoms, physicians or pharmacists may recommend over-the-counter (OTC) therapies. In an effort to develop a comprehensive therapeutic reference guide and a step approach to the clinical management of allergic rhinitis, a panel concluded the use of OTC agents, as either self-directed or parent-directed treatment, based on self-initiative or consultation with health care providers, may result in health care cost savings for both patient and health care provider, as well as reduced risks of overmedication and drug interaction with prescription medications for the patient.

Administration, Oral↗
PubMed1998

Subjective and objective assessments in patients with seasonal allergic rhinitis: effects of therapy with mometasone furoate nasal spray.

BACKGROUND: Efficacy of topical nasal steroid therapy for allergic rhinitis is usually evaluated by patient and clinician assessments of subjective symptom changes in diaries and at clinical interviews. OBJECTIVE: We sought to complement the subjective measures with objective measures of nasal cytology, biochemistry, and function. METHODS: In this double-blind, randomized study patients with seasonal allergic rhinitis (SAR) 12 years of age or older received 200 microg mometasone furoate nasal spray (n = 80) or placebo spray (n = 41) once daily for 2 weeks. Subjective assessments by clinician and patient comprised symptom/sign scores and overall therapeutic response evaluations. Objective measures included nasal cytology, nasal biochemistry, nasal airway resistance (NAR), mucociliary clearance, and olfactory functions. RESULTS: Mometasone furoate produced a significantly greater decrease than placebo in subjective measures of SAR for total symptom score (-46% vs -30%, p < 0.05), total nasal score (-47% vs -30%, p < 0.024), individual nasal symptom scores, and overall therapeutic response. The objective measures of eosinophil, basophil, and neutrophil counts and mucociliary clearance were significantly better in mometasone furoate- than in placebo-treated patients. Similarly, within-treatment statistically significant improvements were produced by mometasone furoate but not by placebo sprays for levels of eosinophilic cationic protein, tryptase and albumin, NAR, and odor identification. Significant positive correlations were found between NAR and nasal stuffiness and between eosinophils, basophils, and neutrophils and both eosinophilic cationic protein and albumin. CONCLUSION: Subjective measures of SAR were significantly improved in the mometasone furoate group by comparison with placebo-treated patients. Objective assessments supported the subjective findings because within-treatment measures were frequently significantly improved after mometasone furoate treatment but not after placebo treatment.

Administration, Intranasal↗
PubMed1998

Clinical and antiinflammatory effects of intranasal budesonide aqueous pump spray in the treatment of perennial allergic rhinitis.

BACKGROUND: Intranasal corticosteroids are among the most effective treatments for perennial allergic rhinitis (PAR). Some individuals unable to tolerate aerosols may prefer an aqueous nasal spray. OBJECTIVE: To determine the efficacy, safety, and antiinflammatory effects of an intranasal aqueous pump spray formulation of budesonide. METHODS: Four hundred seventy-eight patients [257 adults, 221 children (6 to 17 years)] with PAR were randomized to budesonide aqueous pump spray (Rhinocort Aqua) 32, 64, 128, or 256 microg, or placebo once daily for 6 weeks. Patients recorded nasal/ocular symptom severity daily. Nasal cytology was evaluated at baseline and end of treatment. The study was powered only to evaluate the overall population for significance. RESULTS: Following 6 weeks of treatment, significant differences from baseline in nasal index score (NIS)--sum of blocked nose, runny nose, and sneezing scores--were observed in the 32-, 64-, and 256-microg aqueous budesonide groups compared with placebo (P < or = .031). No dose response was found for changes in NIS. Significant reductions from baseline NIS were observed with 256-microg aqueous budesonide compared with placebo in the first 24 hours following treatment (P = .004). Aqueous budesonide also significantly reduced individual nasal symptoms in two or more of the active treatment groups (P < or = .035). Patients' overall treatment efficacy assessments showed significantly greater symptom control with aqueous budesonide (P < or = .006), and overall quality of life improved. Significantly greater decreases in eosinophils and basophils were found in aqueous budesonide-treated groups (P < or = .007). The frequency of adverse events was similar among all treatments. CONCLUSIONS: Once daily aqueous budesonide is well tolerated and effective in relieving nasal symptoms and inflammation associated with PAR.

Administration, Intranasal↗
PubMed1998

Treatment options for the child with allergic rhinitis.

Allergic rhinitis is extremely common in pediatric populations. Its symptoms can interfere markedly with everyday life; moreover, untreated allergic rhinitis can predispose patients toward more serious respiratory diseases. Therapy focuses both on reducing the causes (avoidance, immunotherapy) and on controlling manifest symptoms (pharmacotherapy). Antihistamines, decongestants, anticholinergic agents, mast cell stabilizers, and intranasal corticosteroids constitute the pharmacotherapy arsenal. Of these, the intranasal corticosteroids most effectively control the major symptoms; many studies have found that their efficacy in persistent allergic rhinitis is greater than that of decongestants, antihistamines, and cromolyn sodium. Moreover, unlike systemic corticosteroids, they are generally free from adverse side effects. Thus, with appropriate attention to education and formulations most tolerable to children, they should be a wise choice for many pediatric patients.

Adrenal Cortex Hormones↗
PubMed1998

Pharmacological treatment options for allergic rhinitis and asthma.

The inflammatory response that results in allergic rhinitis and asthma is complex and involves numerous cell types, such as lymphocytes, mast cells, and eosinophils, and mediators, such as histamine, arachidonic acid metabolites, toxic proteins, and cytokines. Therefore, many different classes of pharmacological agents, acting at various discrete points, can influence the symptoms induced by this process. The various classes of agents include antihistamines, decongestants, anticholinergics, leukotriene antagonists, beta-adrenoceptor agonists, theophylline, sodium cromoglycate and corticosteroids. In this article the mechanism of action of each of these classes is discussed, together with their use in allergic rhinitis and asthma.

Anti-Allergic Agents↗
PubMed1997

Pilot study of bronchodilator response to inhaled albuterol delivered by metered-dose inhaler and a novel dry powder inhaler.

BACKGROUND: The metered-dose inhaler is currently one of the most prescribed methods of delivering drugs to the lungs. In the United States, most currently marketed metered dose inhalers use chlorofluorocarbons as the system propellant and require patient breath coordination. These factors lead to the need for a delivery system that is independent of propellants and patient coordination. OBJECTIVE: To compare the magnitude and time course of bronchodilation between albuterol delivered by Ventolin metered dose inhaler and albuterol sulfate powder (Rotacaps) delivered by a novel dry powder inhaler that generates a respirable drug aerosol over a range of inspiratory flow rates. METHODS: A single-center, single-dose, randomized, placebo-controlled, partial-blind, 3-way crossover study was conducted in an outpatient asthma Clinical Research Center. Twelve mild to moderate asthmatic patients 12 to 36 years of age participated in this study that involved three treatments, each separated by three to eight days, consisting of 2 puffs (90 micrograms/puff) albuterol by Ventolin metered-dose inhaler, two inhalations (100 micrograms/puff) albuterol sulfate powder (Rotacaps) by dry powder inhaler, and two inhalations (12.5 mg/inhalation) lactose powder by dry powder inhaler. Spirometry, blood pressure, and heart rate were measured at 30 minutes, 15 minutes, and immediately before treatment and then at 15, 30, 45, 60, 90, 120, 180, 240, and 300 minutes after each treatment. Serum potassium and glucose, and electrocardiograms were measured at 30 minutes before, and 30, 60, 90, and 180 minutes after each treatment. Endpoints were compared with analysis of variance. RESULTS: Five patients (one metered-dose inhaler and four dry powder inhaler) did not respond with > 15% FEV1 increase over baseline within 30 minutes. Metered-dose inhaler and dry powder inhaler mean FEV1 results, respectively, for 11 and 8 responders were 15 minutes in onset, 202.9 and 185.4 minutes in duration, 24.8% and 25.1% maximum change, and 18.6 and 18.2 area-under-FEV1-bronchodilation-curve. Statistical analysis of all patients and responders-only revealed both active treatments to be different from placebo (P = .0018), but not different from each other (P = .1291). No safety endpoints were significantly different among all three treatments (P > .10 for all safety endpoints). CONCLUSIONS: In this study, the dry powder inhaler safely and effectively delivered a commercially available albuterol sulfate powder (Rotacaps) into human lungs with bronchodilation comparable to Ventolin metered-dose inhaler.

Administration, Inhalation↗
PubMed1997

Azelastine nasal spray as adjunctive therapy to azelastine tablets in the management of seasonal allergic rhinitis.

BACKGROUND: Azelastine rhinitis medications (nasal spray and tablets) have been shown to relieve the symptoms of allergic rhinitis. Nevertheless, many rhinitic subjects suffer from acute exacerbations of symptoms that sometimes require additional treatment. OBJECTIVE: To assess the efficacy and safety of azelastine nasal spray as adjunctive therapy to azelastine tablets in the management of symptomatic seasonal allergic rhinitis in subjects who remain symptomatic despite the oral medication. METHODS: A 2-day, randomized, multicenter, double-blind, placebo-controlled, parallel-group study. Two hundred thirty-three subjects with symptomatic allergic rhinitis received azelastine tablets (0.5 mg bid) for a minimum of seven days prior to receiving either azelastine nasal spray (2 sprays per nostril bid) or placebo nasal spray as adjunctive therapy. Efficacy was determined by improvement in rhinitis symptoms that were grouped according to total and major symptom complex severity scores. RESULTS: Mean percent improvements in the total symptom complex severity scores for azelastine were statistically significant (P < or = .05) or showed a trend toward statistical significance (.05 < or = P < .10) versus placebo from the second through the first ten hours after the initial dose and for each of the last five hours of the second day, demonstrating a rapid onset of action and sustained efficacy over the 2-day study period. Azelastine was well tolerated, and no subject discontinued therapy with azelastine due to an adverse experience. CONCLUSION: Azelastine nasal spray can be effectively administered as adjunctive therapy, in an outdoor environment in which subjects are exposed to pollen and other aeroallergens.

Administration, Inhalation↗
PubMed1997

Ipratropium nasal spray in children with perennial rhinitis.

OBJECTIVE: To compare the efficacy and safety of ipratropium nasal spray and placebo administered twice each day for 4 weeks in pediatric patients with perennial rhinitis who had rhinorrhea as a major complaint. METHODS: This was a multicenter, double-blind, parallel group study. Patients aged 6 to 18 years with symptoms of perennial nonallergic (PNAR) or perennial allergic rhinitis (PAR) were randomized to receive ipratropium (42 micrograms per nostril) or placebo nasal spray, double-blind, twice each day for 4 weeks. Efficacy was evaluated by nasal symptoms, especially anterior rhinorrhea, and quality of life. Previous caregivers for rhinitis and medications used in the past were also evaluated. RESULTS: A total of 202 patients were empanelled, 162 with PAR, 40 with PNAR; of these 151 with mild-severe rhinorrhea were evaluated for efficacy. Treatment with ipratropium reduced symptoms of rhinorrhea primarily in patients with PNAR. In patients with PAR this response was less pronounced, and was seen as a modest decrease in the severity of rhinorrhea noted in the first 2 weeks of treatment. Quality of life assessments confirmed that rhinorrhea was bothersome to these pediatric patients, and suggested that treatment with ipratropium nasal spray was associated with an improvement, especially in the patients with PNAR. There were few adverse events; these were similar in the two treatment groups. CONCLUSIONS: Ipratropium nasal spray 0.03% administered at a dose of 42 micrograms/nostril bid is a safe and effective new therapy for control of anterior rhinorrhea in pediatric patients with PNAR. Twice daily administration is adequate for patients with PNAR, but patients with PAR might benefit from more frequent administration (e.g., tid).

Administration, Inhalation↗
PubMed1997

The pharmacological basis for the treatment of perennial allergic rhinitis and non-allergic rhinitis with topical corticosteroids.

The currently available respiratory topical corticosteroids are all effective at reducing the nasal symptoms of itch, sneezing, rhinorrhoea and obstruction associated with allergic rhinitis. The mechanism of action of corticosteroids is related to their anti-inflammatory activities. They have been documented to prevent fluid exudation and reduce the number of circulating inflammatory cells, including lymphocytes, mast cells, basophils, eosinophils, macrophages, and neutrophils. This occurs through multiple mechanisms, e.g. eosinophil infiltration is suppressed by preventing cytokine production, reducing local mechanisms of tissue infiltration, and decreasing eosinophil survival. Furthermore, corticosteroids also reduce preformed and newly-generated mediators (e.g. histamine, tryptase, prostanoids, leukotrienes), and inhibit production of cytokines and chemokines by inflammatory cells (e.g. IL-1 through IL-6, IL-8, RANTES, TNF-alpha, IFN-gamma and GM-CSF). The currently available corticosteroids differ pharmacologically. Fluticasone propionate appears to have the greatest affinity for the glucocorticoid receptor, and binds more quickly and dissociates more slowly from the receptor compared with other corticosteroids, suggesting a more prolonged duration of action. Its increased specificity for respiratory tissue may lead to greater potency with less potential for systemic adverse effects. Fluticasone propionate has been compared with other corticosteroids in animal models for relative topical and systemic potency, and according to these data, it has the most favourable risk-benefit ratio.

Administration, Topical↗
PubMed1997

Toward a simplified measure of asthma severity for applied research.

There is no universally accepted and validated measure of asthma severity. For community research, clinical tests are too costly, and epidemiological assessments provide inadequate data on severity. Symptom measures may offer a practical alternative. This study assessed psychometric properties of symptom ratings of 91 asthmatic children. Reliability and validity of scales created from these items were examined. A sum scale of symptom ratings was internally consistent, reliable across time, and associated with concurrent health indices. This scale may be a practical measure of severity for use in community-based research.

Adolescent↗
PubMed1997

Considerations in pharmaceutical conversion: focus on antihistamines.

The practice of pharmaceutical conversion, which encompasses three types of drug interchange (generic, brand, and therapeutic substitution), is increasing in managed care settings. Pharmaceutical conversion has numerous implications for managed care organizations, their healthcare providers, and their customers. Although drug cost may be a driving consideration in pharmaceutical conversion, a number of other considerations are of equal or greater importance in the decision-making process may affect the overall cost of patient care. Among these considerations are clinical, psychosocial, and safety issues; patient adherence; patient satisfaction; and legal implications of pharmaceutical conversion. Patient-centered care must always remain central to decisions about pharmaceutical conversion. This article discusses the issues related to, and implications of, pharmaceutical conversion utilizing the antihistamines class of drugs as the case situation.

Automobile Driving↗
PubMed1996

Double-strength beclomethasone dipropionate (84 micrograms/spray) aqueous nasal spray in the treatment of seasonal allergic rhinitis.

BACKGROUND: The use of intranasally administered corticosteroid sprays is an established treatment option for seasonal allergic rhinitis. METHODS: In this double-blind, placebo-controlled, multicenter study, 438 patients with moderate to severe symptoms of seasonal allergic rhinitis were treated for 4 weeks with double-strength beclomethasone dipropionate (BDP) aqueous nasal spray (84 micrograms/spray: BDP-ds), once daily; regular-strength BDP (42 micrograms/spray: BDP-rs), twice daily; high-strength BDP (336 micrograms/spray: BDP-hs), once daily; or placebo. BDP-hs was included as a safety comparison group. All treatments were given as two sprays per nostril. RESULTS: Physician-rated nasal symptom scores were significantly improved in all three active treatment groups compared with those of the placebo group within the initial 3 days of treatment. Improvement was maintained throughout the 4-week treatment period. BDP-ds and BDP-rs were equivalent at all time points. The BDP-ds, BDP-rs, and BDP-hs groups had greater numbers of patients with a good or excellent therapeutic response at end point than the placebo group. All treatments were well-tolerated, and no unexpected adverse events were reported. No effects on laboratory evaluations or vital signs were evident for any treatment group. CONCLUSIONS: The results of this study show that BDP-ds given once a day and BDP-rs given twice a day in the same total daily dose are comparably safe and effective in the treatment of patients with seasonal allergic rhinitis.

Administration, Intranasal↗