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Biomedical subjects

E O Meltzer

Publications and source records attributed to E O Meltzer.

At least 55 records · Page 3Linked to original sources
PubMed1996

Comparative outdoor study of the efficacy, onset and duration of action, and safety of cetirizine, loratadine, and placebo for seasonal allergic rhinitis.

BACKGROUND: Cetirizine, a new once-daily highly specific H1-antagonist, has been shown in conventional studies to be efficacious in the treatment of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria. OBJECTIVE: The efficacy, duration and onset of action, and safety of cetirizine, 10 mg once daily, was compared with that of loratadine, 10 mg once daily, and placebo in a field study of patients with seasonal allergic rhinitis. METHODS: This was a randomized, double-blind, parallel, double-dummy study conducted over 2 days in spring allergy season at outdoor parks in San Diego and Iowa City. Study medication was administered at 10:00 AM on both days. After screening, eligible patients completed rhinitis symptom diaries in the park hourly from 7:30 to 9:30 AM (baseline); at 10:30 AM and hourly from 11:00 AM to 4:00 PM (period I); at 6:00, 8:00, and 10:00 PM at home (period II); and the next day in the park hourly from 8:00 to 10:00 AM (period III), and from 11:00 AM to 4:00 PM (period IV). Major and total symptom complex scores, global efficacy and overall satisfaction, and adverse events were assessed. RESULTS: Of the 279 patients (140 men and 139 women; mean age, 29 years) randomized to treatment, 278 were included in the efficacy analysis. Cetirizine produced significantly greater mean reductions than loratadine or placebo in major symptom complex severity scores at all periods (p < or = 0.05), except period I for placebo. Cetirizine also produced mean reductions in total symptom complex severity scores that were superior to loratadine at every evaluation period (p < 0.05) and were statistically different from placebo at period II (p < 0.01). A rapid onset of action was observed with cetirizine, as was a better response pattern in the patient global assessment of efficacy compared with loratadine. Study medications were well tolerated; no patient stopped treatment because of side effects. The incidence of somnolence with cetirizine was 13% versus 2% with placebo (p < 0.05); headache occurred more frequently with loratadine (23%) than with cetirizine (11%, p = 0.03). CONCLUSIONS: Cetirizine relieved rhinitis symptoms more effectively and quickly than loratadine and placebo in this field study of seasonal allergic rhinitis. Both active agents were generally well tolerated.

Adolescent↗
PubMed1996

Fluticasone propionate aqueous nasal spray compared with terfenadine tablets in the treatment of seasonal allergic rhinitis.

BACKGROUND: Comparative studies with topical corticosteroids and antihistamines for treatment of allergic rhinitis have not always demonstrated clear distinctions between the two on the basis of therapeutic efficacy. OBJECTIVE: This study was designed to compare the efficacy and tolerability of fluticasone propionate aqueous nasal spray with those of terfenadine in the treatment of seasonal allergic rhinitis. METHODS: Three hundred forty-eight patients with allergic rhinitis were given fluticasone propionate aqueous nasal spray (200 micrograms once daily), terfenadine tablets (60 mg twice daily), or placebo for 4 weeks in a multicenter, randomized, double-blind, double-dummy, parallel-group study. RESULTS: Clinician-rated total nasal symptom scores after 1, 2, 3, and 4 weeks of therapy and patient-rated total nasal symptom scores throughout treatment were significantly (p <0.05) lower in the fluticasone propionate group compared with the terfenadine group or the placebo group. Terfenadine was not statistically different from placebo on the basis of clinician-related nasal symptom scores, except for sneezing. Total nasal airflow, measured by rhinomanometry, significantly (p <0.05) improved in the fluticasone propionate group compared with the terfenadine group or the placebo group. More fluticasone propionate-treated patients compared with placebo-treated patients had reduced nasal mucosal eosinophil counts after 4 weeks of therapy (p <0.05). No serious or unusual drug-related adverse events were reported. Morning plasma cortisol concentrations after 4 weeks of therapy did not differ among groups. CONCLUSION: Fluticasone propionate aqueous nasal spray is more effective than terfenadine tablets for treatment of seasonal allergic rhinitis.

Administration, Intranasal↗
PubMed1996

Fluticasone propionate compared with theophylline for mild-to-moderate asthma.

BACKGROUND: The inhaled corticosteroid, fluticasone propionate, was compared with the oral bronchodilator theophylline in the maintenance treatment of asthma. OBJECTIVE: The objective of the present study was to compare the efficacy and safety of twice-daily inhaled fluticasone propionate, 50 micrograms, and fluticasone propionate, 100 micrograms, with that of theophylline in the maintenance treatment of mild-to-moderate asthma. METHODS: In this randomized, double-blind, placebo-controlled, parallel-group study, 353 adult and adolescent patients with asthma inadequately controlled with inhaled beta-agonist therapy alone received fluticasone propionate, 50 micrograms, or fluticasone propionate, 100 micrograms, by metered-dose inhaler; theophylline capsules; or placebo twice daily for 12 weeks. Only inhaled albuterol was permitted as needed for acute symptoms. RESULTS: Both fluticasone propionate groups had a significantly greater probability of remaining in the study (ie, meeting asthma stability criteria) than did either the theophylline or placebo group (P < or = .008); 39% and 51% in the theophylline and placebo groups, respectively, were withdrawn due to lack of treatment efficacy compared with 14% and 21% in the fluticasone propionate, 50 micrograms, and fluticasone propionate, 100 micrograms, groups. Both fluticasone propionate groups experienced significantly greater improvement in FEV1 and PEF compared with patients in the theophylline or placebo group (P < or = .004). The incidence of potentially drug-related adverse events was significantly greater in the theophylline group (25%) than in the placebo group (11%) (P = .031), while there were no differences between placebo and fluticasone propionate, 50 micrograms, (18%) or fluticasone propionate 100 micrograms, (22%). CONCLUSION: Twice daily treatment with inhaled fluticasone propionate 50 micrograms or 100 micrograms was significantly more effective than theophylline in the treatment of mild-to-moderate asthma.

Administration, Inhalation↗
PubMed1995

The accuracy of environmental tobacco smoke exposure measures among asthmatic children.

This study determined the reliability and validity of parent-reported measures of environmental tobacco smoke (ETS) exposure among 91 asthmatic children. Test-retest reliability assessments were conducted for environmental, biological and parent-reported measures of ETS exposure. All measures except a urine cotinine assay resulted in satisfactory levels of reliability. The parent-reported measures of ETS exposure were compared to the environmental filter measure of nicotine as well as submitted to a construct validity test. Parent-reported home exposure to ETS proved moderately and significantly correlated to the filter measure. Approximately 80% of all hypothetical constructs agreed with the observed relationships for convergent, divergent and discriminant validity. It was concluded that middle class Caucasian parents' reports of their asthmatic child's residential ETS exposure are reliable and valid. These parent-reported measures should be valuable tools for epidemiological investigations and for clinical programs designed to reduce asthmatic children's residential exposure to ETS.

Adult↗
PubMed1995

Cetirizine in patients with seasonal rhinitis and concomitant asthma: prospective, randomized, placebo-controlled trial.

OBJECTIVE: This study explored the safety and efficacy of cetirizine for treatment of allergic rhinitis and asthma. METHODS: Daily treatment for 6 weeks with cetirizine 10 mg (93 patients) was compared with placebo treatment (93 patients) in a randomized, double-blind parallel study of patients with allergic rhinitis and asthma. This multicenter study was started just before onset of the fall pollen season. Rhinitis and asthma symptoms were assessed twice daily; spirometry was performed weekly. RESULTS: Placebo-treated patients experienced a worsening of rhinitis symptoms from baseline throughout the study, whereas cetirizine-treated patients had a significant improvement in rhinitis symptoms at week 1, which was maintained after onset of the pollen season. Asthma symptoms in the cetirizine group improved from baseline at week 1; symptoms were significantly better than in the placebo group for 5 of 6 weeks of the study. Pulmonary function did not worsen in patients taking cetirizine or placebo; there were no differences between treatments as determined by spirometry. Albuterol use was less frequent in the cetirizine-treated patients for every week of the study, but differences did not reach significance. Pseudoephedrine use was similar in both groups. More cetirizine-treated patients (90%) completed the trial than did placebo-treated patients (74%). Both treatments were well tolerated. CONCLUSION: Cetirizine 10 mg daily is safe and effective in relieving both upper and lower respiratory tract symptoms in patients with seasonal allergic rhinitis and concomitant asthma.

Adolescent↗
PubMed1995

An overview of current pharmacotherapy in perennial rhinitis.

BACKGROUND: Individuals with rhinitis experience significant morbidity due to their disease. Research and clinical care to reduce this suffering are important. OBJECTIVE: To review the pharmacological agents that have been developed for the treatment of perennial rhinitis. METHOD: Literature review of human studies. RESULTS: Medication classes include antihistamines, decongestants, anticholinergics, cromolyn sodium, and corticosteroids. These vary in regard to their pharmacology, efficacy, and adverse effects. Compliance and cost issues are also critical components of the therapeutic regimen. CONCLUSION: Carefully chosen pharmacotherapy based on an understanding of the pathophysiology of the disease, knowledge of the potential of medications, and commitment to an ongoing patient/physician education and monitoring program can lead to improved well-being for individuals with perennial rhinitis.

Cholinergic Antagonists↗
PubMed1995

A pharmacologic continuum in the treatment of rhinorrhea: the clinician as economist.

The economics of medications are now of great concern to health-care providers. Pharmacoeconomic issues are by no means simple, and yet, ironically, they assume greater importance in prescribing for modest disorders like rhinorrhea than for life-threatening conditions. The therapeutic continuum of quality and cost becomes foreshortened, and safety is an additional concern. Choosing the appropriate medication for rhinorrhea, then, can pose a challenge to the clinician, just as choosing a vital medication. This paper reviews the usage, quality, and cost of major therapies for the rhinorrhea that occurs secondary to various conditions, including nasal steroids, antihistamines and anticholinergics, and discusses the role of the clinician in factoring costs into therapy.

Cholinergic Antagonists↗
PubMed1995

Nasal cytological changes following pharmacological intervention.

Symptoms of allergic rhinitis are associated with increased numbers of inflammatory cells in the nasal mucosa. The effects of fluticasone propionate on the nasal mucosal cells of patients with symptomatic allergic rhinitis were evaluated in seven multicentre, double-blind, parallel-group, placebo-controlled, randomised studies. In three seasonal allergic rhinitis studies, significantly more patients receiving fluticasone propionate had a decrease in nasal eosinophils following treatment compared with patients receiving placebo. Similarly, more patients receiving fluticasone propionate had a decrease in nasal basophilic cells, but differences from placebo were not significant in all studies. Nearly identical results were observed in two 24-week perennial allergic rhinitis studies: significantly more patients receiving fluticasone propionate or beclomethasone dipropionate had a decrease in nasal eosinophils compared with patients receiving placebo. Furthermore, a higher percentage of patients receiving corticosteroids also had a decrease in the number of basophilic cells. In two separate seasonal allergic rhinitis studies, significantly more patients receiving fluticasone propionate had a decrease in nasal eosinophils compared with patients receiving terfenadine or astemizole, respectively. The decrease in nasal basophilic cells was also significantly greater with fluticasone propionate compared with astemizole. Inhibition of mediator release from eosinophilic and basophilic cells has also been demonstrated in patients receiving fluticasone propionate compared with patients receiving antihistamines. The results of these studies suggest that the therapeutic benefits of fluticasone propionate aqueous nasal spray in the treatment of seasonal and perennial allergic rhinitis may be related to its ability to reduce nasal mucosal inflammatory cells and to inhibit local mediator activity.

Administration, Topical↗
PubMed1995

Histamine levels and nasal cytology in children with chronic otitis media and rhinitis.

OBJECTIVE: Nasal and middle ear diseases are frequent health problems for young children. In some of these patients, allergic reactions may be contributing factors. The objective of this study was to determine whether the histamine level in nasal mucosal scrapings may be used as a marker for this subset of children. METHODS: A total of 50 children, aged 2 through 7 years, was categorized into five groups of ten subjects as: normal, allergic rhinitis, nonallergic rhinitis, allergic with otitis media and nonallergic with otitis media by history, physical examination, allergy skin testing, nasal cytology, and tympanometry. Nasal mucosal scrapings were obtained using the Rhino-probe technique. Eosinophils, basophilic cells, neutrophils, and bacteria in nasal cytograms were quantified. Histamine levels were measured by radioimmunoassay, the values normalized to the total protein content assayed by enzyme-linked immunoassay, and expressed in pcg/micrograms of total protein. RESULTS: The mean histamine level for each group was: normal = 0.20, allergic rhinitis = 10.14, nonallergic rhinitis = 0.13, allergic with otitis media = 5.34, nonallergic with otitis media = 0.24 pcg/micrograms of total protein. Mean levels of histamine were statistically significantly higher in the allergic groups than in the nonallergic and normal groups (P < .05). Allergic groups had significantly more eosinophils and basophilic cells in the nasal cytograms than the nonallergic groups. By contrast, the cytograms of children with nonallergic rhinitis and nonallergic otitis had significantly more neutrophils than the normal and allergic groups. CONCLUSION: We conclude that measuring histamine in nasal mucosal scrapings could be useful in the evaluation of young children with rhinitis and otitis and in determining which patients may have allergic disease.

Child↗
PubMed1994

A dose-ranging study of the efficacy and safety of azelastine nasal spray in the treatment of seasonal allergic rhinitis with an acute model.

BACKGROUND: Oral azelastine, a nonsteroidal antiinflammatory respiratory investigational drug has demonstrated activity in the treatment of allergic rhinitis and asthma with a good safety profile. METHODS: Azelastine nasal spray was compared with sustained-release oral chlorpheniramine maleate and placebo for efficacy and safety in the treatment of seasonal allergic rhinitis in a double-dummy, two-center, 2-day, double-blind, randomized, dose-ranging, parallel-groups, onset and duration of action study. Two hundred sixty-four subjects reported to an outdoor park on Saturday morning during the height of the fall pollen season and remained there for 8 hours that day and the next to ensure maximal exposure to seasonal aeroallergens. Symptom diary cards were collected hourly Saturday from 8:00 AM to 10:00 AM (baseline period). Subjects who had sufficient symptoms were randomized into five groups and received medication at 10:00 AM and 10:00 PM on Saturday and at 10:00 AM on Sunday: azelastine 0.1% (1 spray [0.12 mg] per nostril every 12 hours, 2 sprays per nostril every every 12 hours, or 2 sprays per nostril once daily), Chlor-Trimeton Repetabs (12 mg twice daily), or placebo (twice daily). Diary cards were completed hourly (11:00 AM to 4:00 PM) and at 6:00, 8:00, and 10:00 PM on Saturday and again hourly on Sunday (from 8:00 AM to 4:00 PM) to evaluate rhinitis symptoms and adverse events. RESULTS: Two hundred fifty-nine subjects completed the study. The groups that received 2 sprays of azelastine per nostril once and twice daily and the chlorpheniramine group had statistically significantly more improvement in total rhinitis symptoms than the placebo group without serious adverse events. CONCLUSIONS: This study supports a once to twice daily dosing regimen for 2 sprays of 0.1% azelastine in the acute treatment of allergic rhinitis with onset of action within 2 to 3 hours.

Administration, Intranasal↗
PubMed1994

Nasal cytology in patients with allergic rhinitis: effects of intranasal fluticasone propionate.

BACKGROUND: Nasal cytograms of patients with allergic rhinitis contain increased numbers of eosinophils and basophilic cells. Neutrophils are also more numerous in cytograms of allergic persons. Topical intranasal corticosteroid therapy for allergic rhinitis has been shown to decrease the numbers of some inflammatory cell types. Fluticasone propionate aqueous nasal spray, a potent synthetic corticosteroid preparation, is effective therapy for seasonal and perennial allergic rhinitis. METHODS: Nasal mucosal scrapings were obtained with a Rhinoprobe (Apotex Scientific, Inc. Arlington, Texas) before and after therapy with fluticasone propionate aqueous nasal spray at several doses in patients with either seasonal allergic rhinitis (2 to 4 weeks' therapy) or perennial allergic rhinitis (24 weeks' therapy). More than 1000 paired nasal cytograms obtained from patients participating in five multicenter studies were evaluated. RESULTS: The percentage of patients with nasal eosinophils (p < 0.01, most studies) and basophilic cells (p < 0.05, most studies) decreased significantly after treatment with fluticasone propionate compared with placebo-treated patients. Similar findings were observed with beclomethasone dipropionate in one study. The number of neutrophils remained relatively unchanged after treatment with the intranasal corticosteroids or placebo. CONCLUSIONS: These findings suggest that the therapeutic benefits of topical intranasal fluticasone propionate and beclomethasone dipropionate for the therapy of seasonal and perennial allergic rhinitis are reflected by the decrease in inflammatory cells in the nasal mucosa.

Administration, Intranasal↗
PubMed1994

Reduction of environmental tobacco smoke exposure among asthmatic children: a controlled trial.

STUDY OBJECTIVE: This randomized clinical trial tested a behavioral medicine program designed to reduce asthmatic children's exposure to environmental tobacco smoke (ETS) in the home. DESIGN: Families were randomly assigned to an experimental preventive medicine counseling group, a monitoring control group, or a usual treatment control group. Families were measured six times over 1 year. PARTICIPANTS: Ninety-one families were recruited from four allergy clinics. INTERVENTION: The experimental group received a 6-month series of counseling sessions designed to decrease ETS exposure. This group also monitored smoking, exposure, and children's asthma symptoms. The monitoring group did not receive counseling and the usual treatment control group received outcome measures only. MEASUREMENTS AND RESULTS: Parents reported the daily number of cigarettes children were exposed to during the week preceding interviews. A nicotine air monitor and construct validity analysis confirmed the validity of exposure reports. Exposure to the parent's cigarettes in the home decreased for all groups. The experimental group attained a 79 percent decrease in children's ETS exposure, compared with 42 percent for the monitoring control and 34 percent for the usual treatment control group. Repeated-measures analysis of variance resulted in a significant (F([10,350] = 1.92, p < 0.05) group by time effect. At the final 12-month visit, the experimental/counseling group sustained a 51% decrease in children's exposure to cigarettes in the home from all smokers, while the monitoring control group showed an 18% decrease and the usual treatment control group a 15% decrease from pre-intervention [corrected]. CONCLUSION: A behavioral medicine program was successful in reducing exposure to ETS in the home for these asthmatic children.

Adolescent↗
PubMed1994

Azelastine nasal spray in the management of seasonal allergic rhinitis.

Azelastine is a novel, investigational, antiallergy medication that inhibits the generation, release, and/or end-organ activity of multiple mediators of the inflammatory process in vitro and in vivo. Azelastine is capable of inhibiting both early-phase and late-phase allergic responses in animals and humans. In this 2-day trial in patients with seasonal allergic rhinitis, we evaluated the onset of action, duration of effect, and safety and efficacy of azelastine nasal solution (Astelin N.S.) in an outdoor, highly allergenic environment. Two hundred ninety-four patients who satisfied entry criteria were randomized to azelastine 2 sprays/nostril q24h or q12h, oral chlorpheniramine maleate 12 mg q12h, or placebo in this multicenter, double-blind, parallel-group study. Rhinitis symptoms were analyzed individually and combined as total and major symptom complexes. For both azelastine treatment groups, the overall mean percent improvements in the total and major symptom complex severity scores were statistically significant (P < or = .05) versus placebo. Improvements in rhinitis symptoms were observed by the second hour after administration of azelastine and lasted up to 24 hours. The therapeutic effect of azelastine was apparent for all rhinitis symptoms, not just one or a few symptoms. Seventy-three percent of the patients treated with azelastine reported overall improvement upon global assessment of their symptoms. Adverse effects with azelastine were generally mild or moderate. Azelastine nasal spray, administered either once or twice daily, was effective in treating the symptoms of seasonal allergic rhinitis and demonstrated a rapid onset of action with a duration of response lasting 12 to 24 hours.

Administration, Intranasal↗
PubMed1994

Prevalence, economic, and medical impact of tobacco smoking.

OBJECTIVE: The goal of this review is to report the epidemiology and risks associated with tobacco smoking. It also suggests reasons and measures to achieve a smoke-free society. DATA SOURCES: References are limited to the English language and human subjects. All are publications from either the United States or the United Kingdom and extend back to the past 50 years. Sources include computerized databases and bibliographies of recent articles and books. STUDY SELECTION: Papers were selected on the basis of their timeliness, credibility of their data, explanation of important findings, extrapolation of clinical data from large patient populations, and clarification of controversial issues. Approximately 60% of the articles initially reviewed are included in the bibliography. RESULTS: Tobacco smoking continues to affect the lives of millions of Americans. The risks of cardiovascular diseases, cancer, and respiratory diseases are significantly increased in both the smoker and in those exposed to environmental tobacco smoke. CONCLUSIONS: Understanding the consequences of tobacco smoking is necessary to effectively mobilize the appropriate political, social, and medical resources to combat this most important health issue.

Advertising↗
PubMed1994

Double-blind assessment of azelastine in the treatment of perennial allergic rhinitis.

Azelastine is a chemically novel multifunctional antiallergy investigational drug capable of inhibiting mast-cell activation and the synthesis and/or release of chemical mediators of the upper and lower airway inflammatory response. In previous controlled clinical trials, azelastine was shown to be effective in treating the symptoms of both seasonal allergic rhinitis and perennial allergic rhinitis. The objective of this 8-week double-blind trial was to evaluate further azelastine's efficacy and safety in improving the symptoms of perennial allergic rhinitis over a prolonged period of treatment. One hundred ninety-nine patients with symptomatic perennial allergic rhinitis were randomized to receive in a double-blind fashion azelastine, 2 mg bid, clemastine fumarate, 1.34 mg bid, or placebo bid for 8 weeks. Patients treated with azelastine had superior mean percent improvements in the total symptom complex score (nose blows, sneezes, stuffy nose, runny nose, itchy nose, and itchy eyes/ears/throat) versus placebo at each evaluation point and overall across all 8 weeks (P < .01) of the trial. Improvements in the individual symptoms of rhinitis were statistically significant (P < or = .04) for nose blows, sneezes, runny nose, itchy nose, and itchy eyes, ears, and throat. Treatment with azelastine also resulted in a clinically meaningful improvement in nasal congestion. Improvement in congestion was accompanied by a decreased requirement for backup decongestant medication. The adverse experiences were generally mild and well tolerated. Azelastine provided effective prolonged relief of the symptoms of perennial allergic rhinitis with no adverse effects that would limit its long-term use.

Administration, Oral↗
PubMed1994

Fluticasone propionate: an effective alternative treatment for seasonal allergic rhinitis in adults and adolescents.

BACKGROUND: Topical corticosteroids are widely regarded as the reference standard in allergic rhinitis therapy because they are well tolerated and effective against all rhinitis symptoms. We evaluated the efficacy, onset of action, and safety of two dosing regimens of the new corticosteroid fluticasone propionate compared with that of beclomethasone dipropionate in patients with moderate to severe seasonal allergic rhinitis. METHODS: In this double-blind, randomized multicenter trial, 110 adolescents and 128 adults were treated for 4 weeks with one of the following regimens: fluticasone aqueous nasal spray 100 micrograms twice daily or 200 micrograms once daily, beclomethasone aqueous nasal spray 168 micrograms twice daily, or placebo. RESULTS: Patient-rated scores for nasal obstruction, rhinorrhea, and combined nasal symptoms indicated that the two fluticasone regimens were equally effective and that both were superior to beclomethasone during most of the study (P < or = .05) and to placebo throughout the study (P < or = .01). Both fluticasone regimens also demonstrated significant clinical efficacy by 24 hours after the first dose. Clinician-rated mean total nasal symptoms scores for all three active treatments were superior to placebo at most time points but were not significantly different from each other. All treatments were well tolerated, with similar incidence and type of adverse events in all treatment groups and no apparent effects on hypothalamic-pituitary-adrenal (HPA) axis function. CONCLUSIONS: Fluticasone aqueous nasal spray was effective in relieving nasal symptoms in adolescents and adults with seasonal allergic rhinitis. Fluticasone administered once or twice daily was superior to beclomethasone administered twice daily in relieving nasal obstruction and rhinorrhea and in reducing nasal symptoms more quickly.

Administration, Topical↗