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Biomedical subjects

D G Tinkelman

Publications and source records attributed to D G Tinkelman.

At least 19 recordsLinked to original sources
PubMed1992

Evaluation of the Multi-Test device for immediate hypersensitivity skin testing.

Test-to-test reproducibility, user variability, and the effect of positive reactions on adjacent negative sites were evaluated for the Multi-Test skin testing device. Twenty-five subjects had skin tests with 24 histamine (1 mg/ml), four glycerosaline controls, and four "dry" controls on two testings 7 days apart. To assess reproducibility from large and smaller histamine reactions and/or their effect on adjacent negative controls, 10 of the 25 subjects were retested once with the same testing format, but histamine at 10 mg/ml was substituted. To determine whether large allergen reactions affect adjacent negative controls differently than histamine reactions, 24 additional patients were retested on arms and back with negative controls adjacent to allergens to which they had prior 3+ to 4+ skin test reactions. Conclusions from 2688 skin tests on 49 patients are as follows: large (mean > 10 mm) histamine reactions reproduced better than smaller (mean < 7 mm) responses--coefficients of variation were 12.3 and 21.4 respectively. A 14% user variability occurred when comparing mean wheal sizes from histamine produced by each nurse and 1.2% when comparing their coefficients of variation. Neither small histamine reactions nor large reactions from histamine and allergens affected adjacent negative controls. We conclude that Multi-Test is a highly reliable skin testing technique that provides good reproducibility of results and low user variability.

Adolescent↗
PubMed1992

Effect of increasing dosage of an inhaled beta-2 specific agonist on pulmonary function, tremor, and cardiovascular indices.

In this investigation we evaluated the effect of increasing dosage, using an inhaled beta-2 specific agonist, pirbuterol, administered by a metered dose inhaler on pulmonary function, tremor, and cardiovascular parameters in nonacute adult asthmatic patients. This study was conducted with a randomized crossover study design in which each individual was administered a single dose of pirbuterol (0.4, 0.8 and 1.2 mg) [corrected] on separate days. Measurements of pulmonary function, tremor (by accelerometer readings), electrocardiogram, blood pressure and pulse were obtained at 0, 15, 30, 60, 90, 120, and 180 minutes following test drug administration where appropriate. These measurements were performed until there had been no change from baseline in tremor by 60 minutes or return of tremor measurements to within 15% of baseline for up to six hours. The data demonstrated that the onset of bronchodilator effectiveness had occurred by 15 minutes after test drug administration (the first testing time). The peak percent change from baseline for the FEV1 occurred at 60 minutes after administration for all three test doses. The duration of activity was never truly established as there was no significant difference between any of the potential side effects for any of the three test drugs at any testing time period. This study demonstrated that with the beta-2 specific agent pirbuterol, administered as a metered dose inhaler, there is little risk of development of skeletal muscle or cardiovascular toxicity when as much as three times the recommended dose is used in a single usage, and that there is no direct correlation between the onset, peak, and/or duration of tremor with the onset and peak of bronchodilator efficacy with this agent.

Adolescent↗
PubMed1992

Pemirolast, a new oral nonbronchodilator drug for chronic asthma.

Pemirolast is a new oral, nonbronchodilator antiallergy medication that is being evaluated for the therapy of asthma. In this multicenter, double-blind, randomized study, 96 patients with mild asthma received pemirolast, 50 mg (n = 34); pemirolast, 25 mg (n = 31); or placebo (n = 31) BID for 6 weeks. Patients were evaluated weekly at the research centers; they maintained daily symptom diaries and measured peak expiratory flow rates twice a day. Methacholine challenge was performed at the start and end of the study. Results with pemirolast, 50 mg BID, showed statistically significant decrease in nocturnal symptoms (P = .02), in composite symptom scores (P = .02) and in bronchodilator use (P = .05) when compared with placebo. There were no statistically significant differences between treatments in pulmonary function tests or in methacholine challenge sensitivity. Pemirolast, 25 mg BID, did not differ from placebo. There were no significant adverse effects. Pemirolast, 50 mg BID, demonstrated sufficient antiasthma activity to warrant further studies in patients with more severe asthma and with higher doses.

Administration, Oral↗
PubMed1991

Analysis of breath sounds in normal and asthmatic children and adults using computer digitized airway phonopneumography (CDAP).

Analysis of breath sounds using the stethoscope is a major part of physicians evaluation of their patients. However, the use of a stethoscope is often inadequate to give quantitative measurements of the clinical state of the individual. In this study a modification of a previously described computer analysis of breath sounds was used to measure sound intensity levels in both normal and asthmatic children who, in most cases, were unable to perform pulmonary function. The intensity levels were derived using a microcomputer-based program that digitizes audio signals and calculates energy values at 25-ms intervals throughout each signal. There were statistical differences between mean intensity levels for normal breath sounds in children between 2 and 6 years and the mean intensity levels for wheezing sounds in the same age group, as well as wheezing sounds in asthmatic patients over the age of 8 years (P less than 0.002). Also, the mean intensity levels for normal breath sounds could be clearly differentiated from intensity levels for other sounds from the chest, including heart sounds and voice sounds. Thus, computer digitized airway phonopneumography (CDAP) proved to be a reproducible, quantifiable method for demonstrating airway obstruction in those children and patients unable to perform pulmonary function testing.

Adolescent↗
PubMed1991

Evaluation of oral terfenadine for treatment of the common cold.

This study was a single center trial comparing the effects of the nonsedating antihistamine terfenadine, at a dose of 120 mg twice a day, with placebo in the treatment of rhinitis symptoms associated with the common cold. Forty-nine subjects were treated with terfenadine, 120 mg twice each day, and 48 subjects were treated with placebo twice each day for four or five days. Evaluations by both subjects and physicians suggest that terfenadine at 120 mg given twice daily marginally improved sneezing and total symptom scores at day 4. When comparing terfenadine to placebo, neither the symptoms nor signs of the common cold improved in a clinically or statistically significant manner. Terfenadine was well tolerated and had a low incidence of side effects. Terfenadine was found to be ineffective in the treatment of the signs and symptoms of the common cold.

Administration, Oral↗
PubMed1991

Utilizing lung sounds analysis for the evaluation of acute asthma in small children.

One of the most difficult aspects of management of acute asthma in the small child is the clinician's inability to quantitate the response or lack of response to bronchodilator agents because of the inability of a child this age to perform objective lung measurements in the acute state. The present study was designed to evaluate bronchodilator responsiveness in children between 2 and 6 years of age with wheezing by means of a computerized lung sound analysis, computer digitized airway phonopneumonography. Children between ages 2 and 6 who were experiencing acute exacerbations of asthma were included in this study population. The 43 children were evaluated by physical examination, pulmonary function testing, if possible, by use of (spirometry or peak flow meter) and transmission of lung sounds to a computer using an electronic stethoscope to obtain a phonopneumograph with sound intensity level determinations during tidal breathing. A control group of 20 known asthmatic patients between the ages of 8 and 52 years who also presented to the office with acute asthma were evaluated similarly. In each of these individuals, a physical examination was followed by complete spirometry as well as computer digitized airway phonopneumonography recordings. Following initial measurements, all patients were treated with nebulized albuterol (0.25 mL in 2 mL of saline). Five minutes after completion of the nebulization all patients were reexamined and repeat pulmonary function tests were performed followed by CDAP recordings. In the study group of children, the mean pretreatment sound intensity level was 1,694 (range 557 to 4,950 SD +/- 745).(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗
PubMed1991

Clinical evaluation of triamcinolone acetonide nasal aerosol in children with perennial allergic rhinitis.

Triamcinolone acetonide aerosol (TAA), a topical corticosteroid, now available for intranasal use, has been shown to be highly effective in the treatment of both seasonal and perennial allergic rhinitis (PAR) in adults. To evaluate the efficacy and safety of TAA in children, 210 patients (ages 4 to 12 years) with PAR were randomly assigned to one of three treatment groups (placebo, TAA 82.5 micrograms/day, or TAA 165 micrograms/day). Medication was given tid over 12 weeks in a double-blind fashion. Response to medication was evaluated using symptom scoring, physician evaluation, and, in 44 patients, nasal airflow determinations by anterior rhinomanometry. The higher dose of TAA (165 micrograms/day) significantly improved rhinitis symptoms relative to placebo: the total nasal symptom score and most individual symptom scores (eg, nasal stuffiness, itch, sneezing) were significantly better, duration of rhinitis symptoms (hours per day) was significantly reduced, and nasal airflow in a subset of patients showed significant improvement. The lower dose of TAA (82.5 micrograms/day) was superior to placebo by the same parameters as the higher dose, but this improvement was not as consistently significant as the higher dose. There were no clinically significant adverse events; nasal irritation and epistaxis were rare with a similar incidence among treatment groups. In conclusion, TAA at 165 micrograms/day was effective in controlling the symptoms of PAR and in improving nasal airflow in pediatric patients; the lower dose (82.5 micrograms/day) was marginally effective. Both doses were safe and well-tolerated in the children studied.

Administration, Inhalation↗
PubMed1991

A pilot study of pemirolast in patients with seasonal allergic rhinitis.

Pemirolast is a potent, long-acting, orally effective antiallergic agent evaluated for clinical activity in prevention of symptoms of seasonal allergic rhinitis. It was evaluated in a randomized, double-blind, placebo-controlled parallel group in season trials to test its safety, tolerance, and prophylactic activity. Thirty-one patients with a history of fall seasonal allergic rhinitis were treated for 6 weeks with pemirolast, 50 mg bid, or placebo beginning approximately 2 weeks before the onset of the ragweed season in Atlanta. Daily evaluation of symptom scores disclosed statistically significantly less sneezing, rhinorrhea, and stuffy nose during treatment with pemirolast. There was, however, no difference for other evaluated symptoms or for the use of rescue medicines. There were no side effects during this short study. This preliminary study indicates that pemirolast may warrant further evaluation for the treatment of allergic rhinitis.

Adolescent↗
PubMed1991

Methacholine challenges in the management of young children.

Methacholine bronchial challenges (MBCs) have been used as an important diagnostic and management tool for physicians who treat children with chronic asthma. Despite this, children less than 5 years of age present significant diagnostic and management questions that can not easily be answered because of their inability to perform standard spirometry, and thus methacholine bronchial challenges. The present study was designed to evaluate with methacholine bronchial challenge small children (between 2 and 6 years of age) with the diagnosis of or a suspected diagnosis of asthma, utilizing a new method of evaluating airflow in small children through sound analysis, Computer Digitized Airway Phonopneumography (CDAP). There were 23 children in the study between the ages of 2 and 6 years with suspected asthma who could not perform pulmonary function tests. A control group consisting of 12 subjects between the ages of 8 and 38 years of age with a history of chronic cough and/or wheezing who could perform pulmonary function tests was also studied. Of the 12 patients over the age of 8 who had MBC, 11 of them had positive challenges with a fall in FEV1 of 19% or greater. The percent change in sound intensity levels from baseline range from 232% to 396% of baseline. There was greater than 200% change in mean intensity levels with a concentration of methacholine that produced a 19% fall in FEV1 in all of the eleven patients. For one individual who had a negative MBC there was only a 16% change in pulmonary function at 25 mg of methacholine with essentially no change in sound intensity level from baseline.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1990

Evaluation of tremor and efficacy of oral procaterol in adult patients with asthma.

Tremor, the most common side effect of ordinary doses of beta 2-agonists, was evaluated in a quantitative manner and compared to improvement in pulmonary function in respect to time of onset, duration, peak effect, and tachyphylaxis with procaterol in adults. Forty-five adult patients with reversible obstructive airway disease were studied during administration of three different dosages of procaterol, 25 micrograms escalating to 100 micrograms, and 100 micrograms twice daily. Tremor was quantitatively evaluated with a Grass model accelerometer. The patients were evaluated during 8 hours approximately every 2 weeks for 8 weeks. Daily diaries of symptoms and side effects were also maintained. The study demonstrated no direct relationship between tremor and pulmonary function as far as time of onset, peak effect, or duration. Although tachyphylaxis was demonstrated, much of the tolerance developed to the tremor was explained by an increase in baseline tremor. Procaterol was demonstrated to be an effective bronchodilator, and tolerance to tremor was demonstrated to develop with time but is highly variable. There was not a direct relationship between tremor and pulmonary function, indicating possible differences between lung and peripheral muscle beta 2-receptors. It appeared that the best way to minimize the problem of tremor is to begin with a lower dose and increase the dose gradually during a period of weeks.

Administration, Oral↗
PubMed1990

Relationship of different serum levels of theophylline on methacholine sensitivity.

With an increased awareness of the importance of bronchial hyperreactivity on the clinical state of asthma, efforts at establishing effective treatment for asthma have been aimed at trying to reduce the level of bronchial hyperreactivity. This study investigated whether or not theophylline at different serum concentrations had any effect on bronchial hyperreactivity, as measured by methacholine challenges. Twelve adult subjects with mild asthma participated. All subjects were atopic and were nonsmokers. Subjects were studied on three separate occasions according to a double-blind, randomized, crossover study design with one of the following medications: two placebo capsules in the morning and evening, a placebo and 250 mg of sustained-release theophylline in the morning and evening, or two 250 mg sustained-release theophylline capsules each morning and evening. Subjects were administered their medication between 5 and 15 days before performing methacholine challenges in the morning at the presumed trough level, and in the afternoon at the presumed peak serum theophylline level. Despite statistically significant differences in the pulmonary function and theophylline levels between the two active dosages (p less than 0.05 for both), there was no difference in methacholine sensitivity at the time of ingestion of the two dosage forms. There was also no correlation between a particular theophylline level and degree of methacholine sensitivity. It was concluded that, although theophylline has significant bronchodilator capability, it has little, if any, effect on bronchial hyperreactivity, as measured by methacholine challenges. Thus, other forms of long-term therapy should be used in reducing bronchial hyperreactivity.

Adult↗
PubMed1990

Evaluation of the safety and efficacy of multiple doses of azelastine to adult patients with bronchial asthma over time.

Azelastine is a new oral antiasthma agent with bronchodilating and antiallergic properties. This 12-wk study compared azelastine (2, 4, 6, and 8 mg) and placebo given twice a day in asthmatics 12 to 60 yr of age requiring daily bronchodilator therapy. Patients were allowed albuterol aerosol, short-acting theophylline, and pseudoephedrine only as needed. The study was completed by 221 asthmatic subjects. No significant differences in symptoms, medication, or pulmonary function existed between groups at baseline. Analysis of the zero hour FEV1 before azelastine administration on eight occasions during the 12 wk of therapy indicated an increasing slope for azelastine 6 mg that was statistically different from that of placebo; similarly, the slope for azelastine 4 mg showed the same trend, but it did not reach statistical significance. All azelastine groups had significant reductions of as-needed medication after 1 wk; only in the 4-mg and 6-mg groups was this reduction sustained for 12 wk. Asthma symptom scores and peak expiratory flow measurements remained stable in the azelastine groups despite significant reductions in concomitant medication administration. Side effects were minor and included: altered taste (30.1 to 51.9%), drowsiness (6.0 to 16.9%), and dry mouth (3.8 to 6.1%). The occurrence of these adverse events decreased with time throughout the study.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1990

Comparison of safety and efficacy of inhaled pirbuterol with metaproterenol.

This multicenter study was performed to compare the safety and efficacy of a new beta-2 selective beta agonist, pirbuterol, with metaproterenol. The study followed a double-blind parallel design evaluating 133 asthmatic patients for 12 weeks. There were essentially no clinical differences between groups and no differences in onset of action, peak effect, side effects, or development of tolerance between these two agents. Our conclusion is that pirbuterol is at least as effective and safe under conditions of chronic administration to asthmatics as metaproterenol and therefore can be considered a suitable alternative for therapy.

Administration, Inhalation↗
PubMed1989

Clinical and bacteriologic features of chronic sinusitis in children.

The clinical and bacteriologic aspects of chronic sinusitis in childhood were studied. Of 35 children who underwent surgical procedures for chronic sinusitis, 22 had positive bacteriologic cultures of aspirates from the sinus. The most common organisms isolated were Haemophilus influenzae, Streptococcus pneumoniae, and Branhamella catarrhalis. Five of eight S pneumoniae strains were relatively resistant to penicillin and resistant to sulfamethoxazole-trimethoprim. All of the B catarrhalis and 20% of the H influenzae organisms were beta-lactamase positive. Overall, 14 of 28 of the bacteria were penicillin resistant. In addition, all 12 children 2 years of age or younger had a positive bacterial culture as compared with much lower rates in older children. Although the incidence of S pneumoniae strains that are relatively resistant seems to be rising, to our knowledge we report the first description of these organisms as significant pathogens in chronic childhood sinusitis. These results indicate that chronic, difficult to manage sinusitis in very young children is frequently bacterial in origin, especially if the patient is 2 years old or younger. In light of the frequent failure of antibiotic therapy and considering the incidence of relatively resistant S pneumoniae strains, puncture of the sinus should be considered early in the course of chronic sinusitis to isolate pathogenic organisms and determine appropriate antimicrobial therapy.

Adolescent↗