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Biomedical subjects

E O Meltzer

Publications and source records attributed to E O Meltzer.

At least 73 records · Page 4Linked to original sources

Intranasal flunisolide spray as an adjunct to oral antibiotic therapy for sinusitis.

BACKGROUND: The diagnosis of sinusitis is difficult and there are few controlled studies of customary therapies. In particular, the possible role of topical intranasal steroid as an adjunct to antibiotic treatment has not been evaluated. METHODS: The study was a multicenter, double-blind, randomized, parallel trial in which patients aged 14 years or older were recruited from allergy practices. All patients had maxillary sinusitis documented by radiographs. Treatment consisted of amoxicillin/clavulanate potassium 500 mg combined with nasal spray of either 100 micrograms flunisolide or placebo to each nostril three times a day for 3 weeks (phase I) followed by administration of flunisolide or placebo nasal spray alone three times a day for 4 weeks (phase II). RESULTS: Clinical symptoms and signs decreased significantly in both treatment groups during phase I (p < 0.01). There was a trend to greater improvement in the patients treated with flunisolide, but only the decrease in turbinate swelling/obstruction was statistically significant at the end of phase I when compared with placebo (p = 0.041). Patients' global assessment of overall effectiveness of treatment was higher for flunisolide than placebo after phase I (p = 0.007) and after phase II (p = 0.08). Maxillary sinus radiographs showed improvement in both treatment groups during phase I (p < 0.004) with somewhat greater regression of abnormal findings in patients treated with flunisolide after phase II (p = 0.066). However, 80% of radiographs were still abnormal at the end of phase I. All types of inflammatory cells were significantly decreased in nasal cytograms in patients treated with flunisolide in comparison with those treated with placebo. Flare-up of sinusitis during phase II occurred in 26% of with those treated with placebo. Flare-up of sinusitis during phase II occurred in 26% of patients treated with flunisolide and 35% of those treated with placebo and tended to be more severe in the latter, although these differences were not statistically significant. Adverse events, mainly gastrointestinal symptoms and headache, were similar in both groups and more frequent in phase I than in phase II, (42 vs 15 patients); these side effects were probably due to the antibiotic. CONCLUSION: The addition of flunisolide topical nasal spray as an adjunct to antibiotic therapy was most effective in global evaluations, tended to improve symptoms, to decrease inflammatory cells in nasal cytograms, to normalize ultrasound scans, and to aid regression of radiographic abnormalities compared with placebo spray.

Administration, Inhalation↗

Once daily fluticasone propionate is as effective for perennial allergic rhinitis as twice daily beclomethasone diproprionate.

BACKGROUND: Fluticasone propionate aqueous nasal spray, a new potent corticosteroid, is effective when given once or twice daily for seasonal allergic rhinitis. METHODS: Fluticasone propionate was compared with beclomethasone dipropionate in a multicenter double-blind, randomized, placebo-controlled, parallel-group study in 466 patients with perennial allergic rhinitis. Adults and adolescents (aged 12 to 71 years) with moderate to severe symptoms, nasal eosinophilia, and a positive skin test reaction (> or = 2+) to a perennial allergen received fluticasone propionate aqueous nasal spray 100 micrograms twice daily or 200 micrograms once daily, or beclomethasone dipropionate aqueous nasal spray 168 micrograms twice daily, or placebo for 6 months. RESULTS: Clinician- and patient-rated scores for nasal obstruction (including obstruction on awakening), rhinorrhea, sneezing, and nasal itching were reduced by the first visit at 7 days after initiation of active treatment and remained lower than those of patients receiving placebo throughout the 6-month treatment period. Nasal eosinophilia was reduced in significantly more patients receiving active treatment. The incidence of adverse events was similar in all four treatment groups except for blood in nasal mucus, which was reported by significantly more patients in the two twice-daily active treatment groups compared with the placebo group. There was no evidence of systemic effects of fluticasone propionate. There were no significant differences between fluticasone propionate given once or twice daily or beclomethasone dipropionate given twice daily for any efficacy or safety evaluation. CONCLUSIONS: Fluticasone propionate aqueous nasal spray given once daily in the morning is safe and effective therapy for perennial allergic rhinitis and is as effective as twice daily dosing with fluticasone propionate or beclomethasone dipropionate.

Administration, Topical↗

Reduction of secondary smoke exposure in asthmatic children: parent counseling.

Epidemiological evidence shows that children's exposure to secondhand tobacco smoke increases their risk of respiratory illness. This study evaluated five families and their asthmatic children (aged 5-14 years) in an outpatient counseling program for reducing the children's exposure to passive smoking. Intervention included biweekly counseling/instructions for parents to limit their children's tobacco exposure. A multiple-baseline, quasiexperimental design was used for self-reported measures of the children's smoke exposure and the parent's smoking frequency. Counseling was associated with smoke exposure reduction of 40-80% from baseline for each of 5 children, with most improvements sustained during follow-up. This study provides support for the development of tobacco exposure prevention programs for children with pulmonary disease.

Adolescent↗

Ipratropium bromide aqueous nasal spray for patients with perennial allergic rhinitis: a study of its effect on their symptoms, quality of life, and nasal cytology.

Ipratropium bromide is an anticholinergic agent with topical activity that has been studied as a freon-propelled aerosol spray for therapy of nonallergic rhinitis. This is the first report of its use both as an aqueous nasal spray and in perennial allergic rhinitis. In this study 123 patients who had symptoms of perennial allergic rhinitis were randomized to receive ipratropium bromide 21 micrograms or 42 micrograms or placebo, one spray per nostril three times a day for 4 weeks. Patients maintained daily diaries of duration and severity of nasal symptoms and were evaluated weekly. Mean duration and severity of rhinorrhea was decreased in both ipratropium bromide treatment groups by comparison with placebo, with consistently greatest improvement in the group treated with ipratropium bromide 42 micrograms per nostril three times a day. No statistically significant differences occurred among treatment groups in duration or severity of postnasal drip, congestion, or sneezing. Seventy percent of patients treated with 42 micrograms of ipratropium bromide thought it had good or excellent effect on rhinorrhea (p less than 0.05 vs placebo); significantly more patients thought that it had improved the quality of life (p = 0.02). No changes occurred in nasal cytology, and no significant local or systemic adverse events occurred. These data indicate that ipratropium bromide significantly decreases the rhinorrhea of perennial allergic rhinitis.

Administration, Intranasal↗

Intranasal anticholinergic therapy of rhinorrhea.

This article reviews the role of anticholinergic therapy for the rhinorrhea that occurs in various rhinopathies, including irritant reactions, perennial nonallergic rhinitis, viral infection rhinitis, allergic rhinitis, and temperature-induced rhinitis. The use of a topical anticholinergic medication, ipratropium bromide, and its ability to inhibit methacholine and rhinitis-induced hypersecretion is emphasized. Ipratropium bromide appears to be both safe and effective in reducing this troublesome symptom.

Administration, Intranasal↗

Long-term comparison of three combinations of albuterol, theophylline, and beclomethasone in children with chronic asthma.

Three combination regimens, (1) inhaled albuterol (ALB) with oral theophylline (THEO), (2) inhaled ALB with inhaled beclomethasone dipropionate (BDP), or (3) inhaled ALB, inhaled BDP, and oral THEO, were evaluated and compared as optimal pharmacotherapy for chronic asthma in 111 children. In this double-blind, parallel-group, multicenter study, children, aged 6 to 16 years with moderately severe asthma (unstable despite daily medications), were treated with one of the combinations for 12 weeks. Patients were evaluated every 4 weeks by spirometry and serum THEO measurement. Patients kept daily symptom diaries, measured peak flow rates twice daily, and recorded adverse events. Treatment groups did not differ in disease or demographic characteristics at study entry. All three combination treatments provided and maintained significant improvement in FVC, FEV1, and FEF25%-75% volume points, and compared with that of pretreatment, with no significant differences between treatments. Throughout the 12-week treatment period, however, patients receiving BDP had lower symptom scores, fewer had more than one asthma attack, fewer required "bursts" of prednisone (p = 0.001), and fewer required rescue medication (p = 0.009). Significantly more patients receiving BDP said that they felt better than they did at the beginning of the study compared with the number of patients not receiving BDP (p = 0.002). Adverse events were similar among treatment groups.

Administration, Inhalation↗

Double-blind study of intranasal ipratropium bromide in nonallergic perennial rhinitis.

We undertook this trial to determine whether ipratropium bromide nasal spray 0.03% (IB) reduced the nasal hypersecretion associated with nonallergic perennial rhinitis (NAPR) without causing excessive dryness or irritation of the nasal mucosa. We compared two drug doses of IB (21 micrograms and 42 micrograms per nostril) to a placebo, administered as two sprays to each nostril twice daily. The study design consisted of a 1-week screening period without treatment, a 1-week single-blind placebo period, a 4-week double-blind treatment comparison period, and a 1-week follow-up period without medication to evaluate nasal rebound. One hundred fifty-two patients were entered and 140 completed the trial. Both doses of IB reduced the severity and duration of rhinorrhea compared with placebo (P = .05 and .03, respectively). Treatment differences were noticeable during the first week of therapy, continued to widen during the second week, and then remained stable throughout the next 2 weeks. There was no evidence of nasal rebound observed during the week after treatment. The drug was well tolerated with side effects limited to infrequent nasal adverse events of nasal dryness, blood-tinged mucus, and epistaxis occurring in 2% to 6% of patients. We conclude that IB is a safe and effective therapy for control of rhinorrhea associated with NAPR.

Administration, Intranasal↗

Diagnosis and "desensitization" in tetanus vaccine hypersensitivity.

A 5-year-old boy was evaluated for a history of an anaphylactic reaction to a DPT immunization at 18 months of age. Cutaneous tests and RAST disclosed high titers of IgE antibody to tetanus toxoid vaccine. Variable sensitivity to different vaccine commercial preparations was demonstrated. Immunization was achieved using a 9-step graded dosing schedule with the tetanus toxoid vaccine to which the patient was least sensitive.

Child, Preschool↗

Intranasal fluocortin butyl in patients with perennial rhinitis: a 12-month efficacy and safety study including nasal biopsy.

Fluocortin butyl (FCB) is a recently developed topical intranasal corticosteroid that is inhaled as a powder and has been demonstrated to be well tolerated and to improve symptoms and signs of perennial rhinitis in previous short-term studies. This multicenter, open-label study evaluated the efficacy and safety of FCB during a 12-month treatment period in patients with perennial rhinitis. Treatment was initiated with one inhalation of FCB in each nostril three times a day (total dosage, 3 mg/day). In subsequent months, one third of the patients was maintained at the dosage of 3 mg/day, one third at a lower dosage of 2 mg/day, and the remaining one third of the patients at a larger dosage of 4 to 8 mg/day. Of 109 patients enrolled in the study, 90 patients (82.6%) completed all 12 months of treatment. Symptom and sign scores decreased significantly (p less than 0.001) at the 2-month evaluation compared to scores at baseline, and the improvement was maintained throughout the 12-month study period. After 12 months, greater than 80% of the patients had substantial control of symptoms. Specimens of nasal biopsies, performed at the beginning and end of treatment, revealed a decrease in eosinophils and other cellular infiltrates, a slight tendency of an increase in mast cell counts, and a trend toward normalization of the nasal mucosa. There were few adverse effects. Mean plasma cortisol levels were normal before and after corticotropin stimulation at baseline and after 12 months of FCB therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intranasal↗

Vocal cord dysfunction in a child with asthma.

Vocal cord dysfunction is uncommon in children. We present the case of a 12-year-old boy with a history of mild, intermittent asthma from 7 to 10 years of age. Subsequently, severe, rapid-onset attacks of respiratory distress occurred with increasing frequency. After a life-threatening attack of airway obstruction with 3 minutes of apnea, he was hospitalized for diagnostic studies. Although pulmonary function tests were normal, laryngoscopy under general anesthesia revealed extremely severe vocal cord spasm induced by minimal contact of the laryngoscope. It required intravenous lidocaine and muscle relaxant to reverse. Spasm was not demonstrable one week later on repeat laryngoscopy and bronchoscopy. No structural abnormalities were seen. There was considerable family stress exacerbated by anxiety about the patient's illness. Parents were told that the condition was different from asthma and probably functional in origin. There have been no further episodes, possibly due to counseling and education in relaxation techniques as well as oral pharmacotherapy for asthma with avoidance of inhaled medications.

Asthma↗

Comparison of intranasal cromolyn sodium, 4%, and oral terfenadine for allergic rhinitis: symptoms, nasal cytology, nasal ciliary clearance, and rhinomanometry.

Topical intranasal cromolyn sodium, 4% solution, and oral terfenadine, 60 mg tablets, both relieve symptoms of allergic rhinitis with few or no adverse effects, but no comparison of their relative efficacy has been reported. In this double-blind, double-dummy study, 79 patients, ages 12-56 years with symptoms of allergic rhinitis, were randomized to receive either active cromolyn sodium, 1 spray in each nostril QID, or active terfenadine BID along with the appropriate placebo spray or tablet for 4 weeks following a 1-week baseline qualification period. Patients' daily symptom scores were reviewed weekly and constituted the primary efficacy measures. Changes in nasal cytology, nasal ciliary clearance, and rhinomanometry were also assessed. The presence of adverse effects and the overall score of medication efficacy at the end of each week was recorded. The cromolyn sodium and terfenadine groups had comparable baseline scores for severity of allergic rhinitis symptoms and both treatments resulted in significant improvement (P less than .0001) with no statistical difference between them for total symptom scores at the end of 4 weeks. Eosinophils in nasal samples were decreased significantly in the cromolyn treated group with no significant change in the terfenadine-treated group. There were no significant differences between treatment groups in ciliary clearance or rhinomanometry. Adverse effects were uncommon and mild. We conclude that cromolyn sodium and terfenadine are comparably effective and well-accepted treatments for allergic rhinitis.

Administration, Intranasal↗

Comparative safety of H1 antihistamines.

In the allergic reaction, mast cells degranulate, releasing inflammatory mediators including histamine. The H1 receptor antihistamines have been developed over the past 50 years to minimize the clinical symptoms caused by this reaction. Currently, H1 antihistamines are taken by approximately 30 million Americans per year. First-generation H1 antihistamines, some of which are available without prescription, can cross the blood-brain barrier and have been reported to produce sedation in 10% to 25% of users. When activities that require mental alertness and concentration are considered--school performance and driving, for example--this effect is troublesome and even potentially hazardous. The newer, second-generation H1 antihistamines (eg, astemizole, cetirizine, loratadine, terfenadine) have difficulty entering the brain because they are typically large, lipophobic molecules that have charged side chains and are extensively bound to protein. Consequently, they appear to induce sedation less commonly than classic antihistamines. Since a primary tenet of medical care has always been primum non nocere--first of all, in the management of clinical illness, do no harm--it is important in these "State-of-the-Art Perspectives" to address the comparative safety of the H1 antihistamines. A number of methodologies have been used to make this assessment, including the multiple sleep latency test, the P300 (P3) wave of the auditory-evoked potential, self-ratings, visual function tests, and tests that measure reaction times, visual-motor coordination, and driving skills. The effect of the interaction of H1 antihistamines with alcohol and tranquilizers also has been examined.(ABSTRACT TRUNCATED AT 250 WORDS)

Central Nervous System↗

A dose-ranging study of fluticasone propionate aqueous nasal spray for seasonal allergic rhinitis assessed by symptoms, rhinomanometry, and nasal cytology.

Fluticasone propionate is a new glucocorticosteroid with potent topical activity. In a double-blind, randomized, parallel-group study, 423 adult patients with moderate to severe seasonal allergic rhinitis received placebo or fluticasone propionate aqueous nasal spray at doses of 25, 100, or 400 micrograms twice daily (b.i.d.) for 2 weeks. Efficacy was evaluated by nasal symptom scores, nasal airflow, nasal cytology, and global evaluation. All doses of fluticasone propionate were significantly better than placebo in reducing symptoms of seasonal allergic rhinitis. Patients receiving the largest dose of fluticasone propionate (400 micrograms b.i.d.) had a slightly greater reduction (not significant) in symptom scores than patients receiving the smallest dose (25 micrograms b.i.d.). Symptom improvement was evident within 3 days of treatment. Nasal airflow improved in the groups treated with fluticasone propionate, 100 and 400 micrograms b.i.d. Examination of nasal cytograms revealed a striking decrease in both eosinophils and basophils in all three groups receiving active treatment compared with placebo. There were few adverse events and no treatment-related abnormalities in laboratory assays or evaluations of hypothalamo-pituitary-adrenocortical axis function. Comparison of treatment groups indicated that fluticasone propionate aqueous nasal spray was as safe as placebo at the doses studied.

Administration, Intranasal↗

Performance effects of antihistamines.

In 1988 an estimated 30 million Americans spent more than $500 million for single-entity antihistamines. Classic first-generation antihistamines, which are available without prescription, can cross the blood-brain barrier and have been reported to produce various central nervous system effects. Sedation, the most common adverse effect of these agents, occurs in 10% to 25% of antihistamine users. Drowsiness has been attributed to the blockade of central histaminergic receptors; antagonism of other brain receptors, such as serotonergic, cholinergic, and central alpha-adrenergic receptors, has also been proposed. The newer second-generation H1-receptor antagonists are typically large, lipophobic molecules with a charged side chain and are extensively bound to albumin. Consequently, these agents have difficulty entering the brain, and they appear no more likely to induce sedation than does placebo. The effects of antihistamines on psychomotor reflexes and driving, antihistamine-induced drowsiness, and interaction of antihistamines with alcohol and tranquilizers have been studied with numerous methodologies. The centrally acting first-generation agents commonly cause greater performance decrements as compared with the newer, nonsedating, second-generation antihistamines.

Automobile Driving↗