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Biomedical subjects

E O Meltzer

Publications and source records attributed to E O Meltzer.

103 records · Page 6Linked to original sources

Steady-state evaluation of twice-a-day dosing of a new sustained-release theophylline preparation for young children.

We studied the absorption properties of a new sustained-release theophylline, Theo-Dur Sprinkle (TS), to see if this formulation when given on a b.i.d. basis results in acceptable steady-state theophylline levels in children with asthma. Twelve patients (ages 5-8 years), after multiple TS dosing, had serum theophylline levels determined over a 10-hr period after a morning TS dose. Fluctuations in serum theophylline concentrations were acceptable with the observed mean percent peak-to-trough fluctuation [(peak-trough/trough) x 100] being 53%. Patients required higher than usually recommended theophylline doses to obtain therapeutic levels, suggesting incomplete absorption of TS; this was documented with one patient using a 100% bioavailable theophylline product as a comparison.

Absorption↗

Therapeutic efficacy and equivalence of tablet and syrup formulations of procaterol hydrochloride in childhood asthma.

It has been reported that albuterol syrup produces more improvement in pulmonary function and greater increases in heart rate than an equal dose of albuterol tablets in asthmatic children. Consequently, tablet and syrup formulations of a new beta 2-adrenergic drug, procaterol hydrochloride, were tested for efficacy and equivalence. The two formulations were compared after the first dose and after 1 week of double-blind treatment in 11 children. Statistical analyses indicated that there were few significant differences in the bronchodilating efficacy of the tablet and syrup formulations. Improvement in pulmonary function began within one-half hour postdose and continued until four to six hours postdose. Increases in heart rate were small. Adverse effects were similar for the two formulations. Five patients showed minimal electrocardiogram changes. Tremor, reported by four patients, was the only other adverse effect. In conclusion, the tablet and syrup formulations of procaterol hydrochloride were equivalent in bronchodilating efficacy and safety in childhood asthma.

Adrenergic beta-Agonists↗

Assessment of the correlation of rhinometry with the symptoms and signs of allergic rhinitis in children.

The measurement of nasal patency by anterior rhinometry is a potentially useful tool in evaluating patients with various forms of rhinitis. This study measured both nasal air flow by anterior rhinometry and symptom/sign scores in 49 children with perennial allergic rhinitis. We found that anterior rhinometry in children is (1) a simple, rapid procedure, (2) well accepted by the pediatric patient, and (3) a valid technique for objectively assessing and quantifying the somewhat subjective parameters that physicians traditionally follow for allergic rhinitis.

Administration, Intranasal↗

Beclomethasone dipropionate nasal aerosol spray in allergic rhinitis: a comparison of three delivery systems.

In this 3-way crossover study, the currently marketed beclomethasone dipropionate aerosol canister was sprayed intranasally through three different delivery adapters by 48 adult patients with allergic rhinitis. The adapters were evaluated and compared for force of spray, ease of use, preferred length of nozzle, and effectiveness. While all three were considered effective for symptom relief, there was a clear preference for both of the new longer, snout-like nozzle adapters over the currently available delivery system.

Adult↗

Concomitant bitolterol mesylate aerosol and theophylline for asthma therapy, with 24 hr electrocardiographic monitoring.

A higher incidence of fatal asthma after increased use of combined inhaled beta 2-agonists and theophylline has been attributed to additive cardiac toxicity of these agents. This study had three major objectives: first, to evaluate the efficacy and safety of a new long-acting beta 2-agonist, bitolterol mesylate, given as metered-dose aerosol in a regular "round-the-clock" asthma medication regimen; second, to compare the efficacy and safety of bitolterol with those of sustained-release theophylline alone and of the combination of bitolterol and theophylline; third, to use 24 hr Holter monitoring to evaluate cardiac toxicity of the three medication regimens. This was a 6 wk double-blind study of regular, daily medication in 36 young non-steroid-dependent and 37 older steroid-dependent stable asthmatic patients. All patients had two 24 hr Holter ECG monitorings during the 2 wk baseline period when all patients received theophylline only and four further 24 hr Holter monitorings during the double-blind period. All Holter recordings from the study groups showed no significant abnormalities in any treatment group. Pulmonary function studies were performed on 4 study days in the 6 wk double-blind period. The largest increase in bronchodilator effect was obtained with combined medication and the smallest with theophylline alone. Mean duration of action was markedly longer in the combined treatment group (greater than 7 hr) than with bitolterol mesylate aerosol or theophylline alone (greater than 5 and greater than 4 hr, respectively) in the non-steroid-dependent patients. Degree of bronchodilation and duration of action was less in the steroid-dependent patients in all treatment groups. There is no evidence from cardiac monitoring that therapeutic doses of bitolterol mesylate or theophylline alone or in combination have cardiotoxic effects.

Adolescent↗

The safety of egg-containing vaccines for egg-allergic patients.

Forty-two patients with a history of egg sensitivity were evaluated for receiving avian-grown vaccines. After giving a history and undergoing physical examination, each patient was skin-tested with egg antigens and six egg-propagated vaccines, given an oral egg challenge, and finally, when possible, given a vaccine challenge. Thirty-seven of the 42 patients (88%) were ultimately given one or more of the vaccines with no reactions or only minimal ones to both egg protein and vaccine; they had mild reactions consisting of pruritus, headache, and apprehension. Immunization was withheld from three patients who had a history of severe reactions after egg ingestion and strongly positive skin reactivity to both egg and vaccine. A history of egg intolerance should not, by itself, disqualify a patient from receiving one of these vaccines. However, a history of exquisite sensitivity to egg protein indicates that a severe vaccine reaction is likely. An intradermal skin test utilizing 0.02 ml of a 1:100 dilution of the vaccine and resulting in a wheal of greater than 5 mm was found to be the test that most reliably predicted those patients who should not receive the vaccine.

Administration, Oral↗

Multi-center, double-blind, placebo-controlled trial of fluocortin butyl in perennial rhinitis.

Fluocortin butyl (FCB) is a newly synthesized corticosteroid with a high ratio of topical to systemic activity. FCB was studied in a multi-center, double-blind, placebo-controlled trial of therapy of perennial rhinitis. The study was conducted between January and May 1981. Patients evaluated suffered from either chronic allergic or chronic nonallergic rhinitis or both. A total of 306 patients from 16 investigative centers were evaluated by comparing FCB to placebo. Three separate dosage regimens were employed. Patients received a total daily dose of 2, 4, or 8 mg. FCB was found to be an effective therapeutic agent. It reduced symptoms of nasal congestion, rhinorrhea, postnasal drainage, and sneezing. It also markedly reduced the use of concomitant medications (chlorpheniramine maleate and/or pseudoephedrine). Relief of symptoms was noted as early as the first week of therapy, and the degree of improvement increased progressively during the study. There was little difference between the relief produced by the 4 mg and 8 mg regimens. Both of these were superior to the 2 mg regimen. The drug was well tolerated; no significant side effects were noted.

Adult↗

Flunisolide aerosol in treatment of steroid-dependent asthma in children.

The efficacy of flunisolide aerosol in permitting the reduction of oral steroid dosage without deterioration of asthma was studied in 34 children requiring at least 10 mg prednisone g.o.d. This was a double-blind, placebo-controlled, parallel study lasting 14 weeks. Progress was evaluated daily by symptom scores, bronchodilator use and Wright Peak Flow measurement and every two weeks by spirometry and physical examination. Adrenal function and throat culture for Candida were evaluated before and after the study period. Similar reduction in mean prednisone dosage was achieved in flunisolide and placebo patients. However, flunisolide patients improved and placebo patients deteriorated clinically. These changes were gradual and frequently not detected at bi-weekly evaluation. No patient developed thrush, adrenal suppression or other adverse reaction. Flunisolide aerosol was shown to be safe, acceptable and effective in permitting reduction of oral steroid dosage without increase in symptoms.

Adolescent↗

Terbutaline sulfate and isoproterenol sulfate (metered dose aerosols) in the treatment of asthma.

A double-blind randomized study of 50 patients was conducted to evaluate the efficacy and safety of terbutaline sulfate aerosol and isoproterenol sulfate aerosol in the treatment of patients with moderate to severe asthma. The patients were randomized to receive either terbutaline or isoproterenol (two sprays, four times a day) for 14 weeks with office evaluations at three week intervals. On that day pulmonary function studies as well as electrocardiographs (EKG), blood chemistry analysis and urinalysis were performed before, and pulmonary function studies and EKG at intervals for four hours after, study medications were taken. Terbutaline sulfate was shown to have a much more sustained effect and a larger "area under the curve" than isoproterenol, but the magnitude of the peak effect was similar. There was no statistically significant difference in pulmonary function responsiveness throughout the duration of this study with either medication. Few patients experienced serious adverse reactions and no EKG changes were noted.

Adolescent↗

Flunisolide aerosol for treatment of severe, chronic asthma in steroid-independent children.

The efficacy and safety of flunisolide aerosol were studied in 46 steroid-independent children with asthma inadequately controlled by nonsteroid drugs. This was a double-blind, placebo-controlled, parallel study lasting eight weeks. Patients were randomly assigned either flunisolide by inhalation, 0.5 mg twice a day, or placebo. Effectiveness was evaluated daily by symptom scores, by Wright peak flow measurements twice daily, and weekly by spirometry and physical examination. Adrenal function and throat cultures for Candida were evaluated before and after the test-drug treatment period. Flunisolide was administered to 25 patients and 21 received placebo. Most symptom scores were statistically significantly better in flunisolide-treated than in placebo-treated patients; these included severity of wheezing (P = .01), chest tightness (P = .01) and shortness of breath (P = .02), and frequency (P = .001) and severity of asthma attacks (P = .03). In addition, placebo-treated patients used significantly more bronchodilators than flunisolide-treated patients. In the final therapeutic effectiveness evaluation, 72% of flunisolide-treated patients received very good or good ratings, whereas only 29% of placebo-treated patients received these ratings (P = .005). No patient developed thrush, evidence of adrenal suppression, or other severe adverse reaction. Flunisolide aerosol was shown to be effective and safe in controlling asthma in children who were candidates for oral steroid therapy.

Administration, Topical↗

Atopy and IgE in a pediatric allergy practice.

In children under six years of age referred to a pediatric allergy practice the usefulness of serum IgE assay was evaluated in relation to age, symptoms, nasal eosinophilia, skin tests and family history. In more than 60% of the children the initial symptom, usually rhinorrhea, had occurred before one year of age. In infancy the diagnosis was more difficult, gastrointestinal complaints were more frequent and nasal eosinophilia less frequent than in the older children. Many infants had positive skin tests to foods and to environmental allergens. There was a significant correlation between elevated serum IgE level and age, nasaeosinophilia, the number of positive skin tests and the probability of immunotherapy being prescribed. Although no clear diagnostic level is seen, an IgE level above 100 micron/ml at any age and an IgE level above 20 micron/ml in infants strongly suggest the possibility of atopic disease. However, a low IgE level does not exclude atopic disease.

Aging↗