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Biomedical subjects

C W Bierman

Publications and source records attributed to C W Bierman.

At least 19 recordsLinked to original sources
PubMed1996

Efficacy and safety of inhaled bitolterol mesylate via metered-dose inhaler in children with asthma.

BACKGROUND: There have been numerous studies in asthmatic adults demonstrating the efficacy and safety of bitolterol mesylate metered-dose inhaler; however, only one additional study has examined bitolterol metered-dose inhaler in pediatric asthma. OBJECTIVE: To establish the safety and effectiveness of bitolterol mesylate metered-dose inhaler at one, two, and three inhalations in pediatric asthmatic patients 4 to 12 years of age. METHODS: A multicenter, double-blind, randomized, crossover, placebo-controlled, dose-ranging study. Forty-six patients were evaluated in three centers. Patients were stratified by age, 4 to 6, 7 to 9, 10 to 12 years at each center. One, two, or three inhalations were administered along with an additional double-blind, randomized, placebo dose. Bronchodilation was defined as a 15% or greater increase in FEV1 over baseline. Onset, maximum improvement, and duration of action were obtained for each patient. Serial pulse rate, blood pressure, and respiratory rate determinations were obtained for each patient. RESULTS: Onset within five minutes occurred in 56.6% to 71% of patients, depending on the dose. Mean maximum improvement, which was dose dependent, overall ranged from 28.2% to 40.3% with a peak response in 66.7 to 69.8 minutes. In direct relationship of magnitude with regard to dose of bitolterol was observed, (P < .001). A significant correlation, r = .732, in response between bronchodilation and baseline FEV1 was observed (P < .001). Median duration of action ranged from three to four hours in responding patients across all doses. Up to 31% of patients had durations greater than eight hours after three inhalations. Adverse effects were reported in five of 46 patients for all doses with mild transient tremor occurring in two patients, 4.3%. Also, there was little effect on pulse rate, 2.2%. CONCLUSION: Bitolterol is an effective bronchodilator with durations of activity up to eight hours and minimal adverse effects in children.

Administration, Intranasal↗
PubMed1994

A 1-week dose-ranging study of inhaled salmeterol in patients with asthma.

STUDY OBJECTIVE: A dose-ranging study was conducted to evaluate the efficacy and safety of a new long-acting, selective beta 2-adrenoceptor agonist, salmeterol. DESIGN: Adolescents and adults (N = 160) with mild-to-moderate asthma received salmeterol (10.5, 21, 42, or 84 micrograms) or placebo by metered-dose inhaler twice daily for 1 week. Twelve-hour serial spirometry measurements were performed on the first and last days of treatment, and patients recorded their peak expiratory flow (PEF) twice daily on diary cards. RESULTS: On day 1, salmeterol produced greater bronchodilation than placebo (p = 0.001), and both the 42-micrograms and 84-micrograms doses of salmeterol were significantly more effective in improving FEV1 responses than the two lower doses of salmeterol (p < 0.05). After 1 week of treatment, all but the 21-micrograms dose of salmeterol remained statistically superior to placebo (p < 0.01), but significant differences between salmeterol doses were no longer evident, despite an apparent dose-response effect. Only the 42-micrograms and 84-micrograms doses of salmeterol sustained bronchodilation for 12 h in the majority of patients at both treatment days. The degree of improvement in morning and evening PEF was also found to be dose related. There was no significant difference among treatment groups in the overall incidence of adverse events; however, pharmacologically predictable events (eg, tremor) occurred significantly more often with salmeterol, 84 micrograms. CONCLUSIONS: Salmeterol, 42 micrograms, was similar in efficacy to 84 micrograms but was associated with a lower incidence of adverse events. Salmeterol, 42 micrograms twice daily, is a safe and effective dosage for patients with mild-to-moderate asthma who are persistently symptomatic and require maintenance bronchodilator therapy.

Administration, Inhalation↗
PubMed1993

Dose-response study of inhaled salmeterol in asthmatic patients with 24-hour spirometry and Holter monitoring.

Salmeterol is a new long-acting beta 2-selective adrenoceptor agonist. In this double-blind, 6-way crossover study, four single doses of salmeterol by metered dose inhaler (12.5, 25, 50, 100 micrograms) were compared with albuterol aerosol 200 micrograms and placebo in 24 patients with moderate asthma with 24-hour pulmonary function testing and Holter monitoring. Salmeterol was an effective bronchodilator at each dose evaluated and demonstrated a greater increase in FEV1 above baseline, a slightly slower onset and a longer duration of bronchodilation than albuterol. Median durations of bronchodilation were 9.0, 15.6, 13.4, and 18.4 hours with increasing doses of salmeterol in comparison to 4.2 hours for albuterol. Holter monitoring showed (1) a mean maximum heart rate 2 to 5 bpm higher after salmeterol 50 and 100 micrograms compared with placebo and (2) supraventricular premature beats (> 30 per hour or > 100 per 24 hours) more often in the salmeterol 100-micrograms group (13% to 17% of patients) than in the placebo (4%), albuterol (4% to 8%), or other salmeterol groups (4% to 9%). These differences were not statistically significant. Tremor and palpitations were the most frequently reported drug-related adverse events and their frequencies increased with increasing doses of salmeterol. This study demonstrated that single doses of salmeterol given by metered dose inhaler over an 8-fold range possess substantial, long-lasting bronchodilator activity.

Administration, Inhalation↗
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

Cromolyn versus triamcinolone acetonide for youngsters with moderate asthma.

Although both cromolyn (C) and inhaled corticosteroids are anti-inflammatory therapies for childhood asthma, there are few controlled comparisons of these medications for asthma therapy in children. None were conducted in the United States, and none specifically study triamcinolone acetonide (T) versus C. This 12-week evaluation followed 31 youths, aged 8 to 18 years, with moderate asthma who were assigned to receive C or T according to a prerandomized and blinded code. Patients were instructed to take two inhalations from the study metered-dose inhaler (active T or placebo) and to inhale the contents of one study-provided ampule (C, 20 mg, or placebo) from a compressor-driven home nebulizer three times per day. Patients also used albuterol, two inhalations from a metered-dose inhaler, three times a day (before study medication) and, additionally, if needed. Patients maintained a daily diary, recording extra medication use, adverse experiences, peak flow rates morning and night, and asthma symptom scores. Laboratory assessment of pulmonary function was done at 1, 4, 8, and 12 weeks. Cosyntropin challenge and methacholine bronchoprovocation challenge were performed at the beginning and end of the study. C and T provided similar, adequate asthma control. Symptoms of wheezing, cough, and chest tightness decreased, and daily peak expiratory flow rate increased with both regimens compared to during a 2-week baseline when patients received medication only as needed. There was no significant change in methacholine sensitivity and no change in endocrine function, as measured with fasting plasma control before and after administration of cosyntropin.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Inhalation↗
PubMed1991

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↗
PubMed1991

Effect of H1-receptor blockade on late cutaneous reactions to antigen: a double-blind, controlled study.

This study is of the effect of the blockade of histamine H1 receptors by a long-acting antihistamine on the immediate and late clinical response to antigen (Ag) and on the recruitment of eosinophils in the late-phase cutaneous reaction. Ten adult volunteers with late-phase reactions to the intradermal injection of either Dermatophagoides pteronyssinus or Phleum pratense (timothy) pollen performed a double-blind, crossover study. Each volunteer took astemizole, 10 mg, or identical placebo, daily for 2 weeks. Ag in the concentration that induced a late reaction in the screening visit was injected intradermally at the end of each drug period. The early reaction was measured serially for 30 minutes and the late reaction at 4 and 6 hours. Biopsies of the Ag and control sites were also performed at 6 hours. After a 6-week washout period, subjects then took the opposite medication for 2 weeks and returned for skin testing and biopsy. Skin testing demonstrated that astemizole inhibited the immediate response to both histamine and allergen but had no effect on the late response at 4 hours and at 6 hours. Biopsy specimens revealed no significant effect on eosinophil recruitment at 6 hours. We conclude that histamine H1-receptor blockade has no effect on the late cutaneous reaction to Ag.

Antigens↗
PubMed1991

Metaproterenol (Alupent) metered dose inhaler in children 5-12 years of age.

This multiclinic study was performed to evaluate the safety and efficacy of metaproterenol sulfate (Alupent) metered dose inhaler in children with asthma ages 5 to 12 years. A total of 268 children completed this study according to the protocol, having received either metaproterenol or placebo for 30 consecutive days. Full spirometric testing was done pre- and postdose on Days 1 and 30 for a total duration of 6 hours on each day. The results showed that metaproterenol was consistently superior to placebo in all pulmonary function parameters measured on Days 1 and 30. This difference was statistically significant for peak values and areas under the curves for both FEV1 and FEF25-75%. There were no significant side effects noted. We conclude that metaproterenol metered dose inhaler is safe and effective in the treatment of asthma in children ages 5 to 12 years.

Administration, Inhalation↗
PubMed1991

Immunologic defects in patients with refractory sinusitis.

Sixty-one patients with chronic sinusitis who were referred for an allergy evaluation were evaluated for immunologic competence including assessment of quantitative serum immunoglobulin levels, IgG subclass levels, and response to pneumococcal and Haemophilus influenzae vaccines. In addition to chronic sinus disease, recurrent otitis media and asthma exacerbation were common problems in this group. Five patients had an elevated age-adjusted IgE level and 22 patients had positive prick tests to one or more environmental inhalants; these findings suggest an allergic component in this subgroup. Twelve additional patients had highly reactive intradermal tests to common environmental allergens, which also may be clinically significant for underlying atopy. Eleven patients had low immunoglobulin levels, 6 had low immunoglobulin levels and vaccine hyporesponsiveness, and 17 had poor vaccine response only. Thus, 34 of 61 patients with refractory sinusitis had abnormal results on immune studies, with depressed IgG3 levels and poor response to pneumococcal antigen 7 being most common. In addition to allergy, immunologic incompetence may be an important etiologic factor in patients with chronic, refractory sinusitis.

Adolescent↗
PubMed1990

Effects of albuterol and procaterol on exercise-induced asthma.

Procaterol and albuterol, beta agonists, were studied using a placebo-controlled, repeated exercise challenge design in order to assess their duration of effectiveness in both bronchodilation and in modifying exercise-induced asthma (EIA). Fifty-three subjects aged 12 to 50 years who had at least a 20% drop in FEV1 during a screening exercise tolerance test were entered. Subjects took two inhalations of procaterol (10 micrograms/inhalation), albuterol (90 micrograms/inhalation), or placebo. Thirty minutes later they exercised on a treadmill at a workload sufficient to induce greater than or equal to 80% aerobic O2 consumption for six minutes. Pulmonary function was measured before and serially for 30 minutes after exercise. The same exercise challenge was repeated three, six, and nine hours after drug administration. Both procaterol and albuterol bronchodilated and modified EIA at 30 minutes and three hours, mean drops in FEV1 being 8.2 and 9.7% respectively at 30 minutes and 16.8 and 16.3% at three hours. This was compared with placebo falls of 30% and 26%. At six hours the subjects' response was similar after both procaterol and albuterol, and fewer subjects had a 20% fall in FEV1 than with placebo, although protection afforded by both beta agonists was substantially less than at three hours. Both drugs were tolerated well.

Adolescent↗
PubMed1989

Clinical expression of bronchial hyperreactivity in children.

Airway hyperreactivity is a consistent finding in most children with asthma and is responsible for many clinical manifestations of asthma. BH in children has been elicited by bronchial challenge with methacholine and histamine, cold air (isocapnic hyperventilation), and exercise. Pharmacologic agents employed in therapy of childhood asthma, which may modulate both the late asthmatic reaction and bronchial hyperreactivity, include cromolyn sodium, glucocorticoids, and possibly ketotifen. Beta adrenergic agonists, though effectively blocking the early asthmatic response, had no effect on the late response and did not alter bronchial hyperreactivity. Theophylline, in both children and adults, and enprophylline (not yet studied in children) may modify both the early and late responses, but do not appear to have an effect on bronchial hyperreactivity. New drugs that may have potential value in reducing bronchial hyperreactivity include calcium channel blockers and PAF antagonists.

Airway Resistance↗
PubMed1989

Therapeutic monitoring of theophylline. Rationale and current status.

Theophylline has been demonstrated to be a useful agent in the therapy of chronic asthma. Its use must be tempered with knowledge of its adverse effects and that these effects are related primarily to serum concentration. Accordingly, it is mandatory to monitor serum theophylline concentrations on a regular basis with any patient receiving maintenance therapy with theophylline. It is also necessary to recognise the potential side effects of theophylline therapy, and when such a patient displays symptoms of vomiting, headache or seizures, serum theophylline concentration must be checked even if a recent concentration was within the therapeutic range. The means for monitoring theophylline concentrations are now available even to the average physician who does not have immediate access to a laboratory that can provide timely serum theophylline determinations.

Adult↗
PubMed1989

Terfenadine blockade of exercise-induced bronchospasm.

Terfenadine, in doses of 60, 120, and 180 mg, provided significant bronchodilation for up to four hours after administration. In addition, when the same doses were given four hours prior to exercise, the drug demonstrated significant blockade of exercise-induced bronchospasm at two and five minutes postexercise. These effects on exercise-induced bronchospasm followed a dose-response curve; 180 mg had the most significant effect. All dosing levels, however, produced both bronchodilation and a significant degree of blockade of exercise-induced bronchospasm. No patients were bothered by adverse effects during this single-dose study. Eight of the 11 subjects who completed the study also noted some improvement in their nasal congestion during the testing period when they were on the active drug.

Adolescent↗
PubMed1988

Is a uniform round-the-clock theophylline blood level necessary for optimal asthma therapy in the adolescent patient?

Twenty-one patients, 12 to 18 years of age, with nocturnal asthma controlled with sustained-release theophylline administered twice daily, were enrolled in a 10-week, double-blind, two-way crossover study that compared Theo-Dur tablets administered twice daily with an equivalent daily dose of Uniphyl tablets administered once daily at bedtime. Seventeen patients completed the study. The mean morning theophylline serum level obtained with Uniphyl tablets was significantly higher than that obtained with Theo-Dur tablets (13.1 versus 9.6 micrograms/ml, p = 0.02). The mean evening serum level was significantly lower with Uniphyl tablets (6.3 versus 10.1 micrograms/ml, p = 0.003). Despite these differences in serum concentrations, morning and evening pulmonary function test values (forced expiratory volume in one second and peak expiratory flow rate) and symptom scores were nearly identical for the two preparations, as was the supplemental use of aerosol bronchodilators. Once-daily dosing with Uniphyl tablets may benefit adolescent patients with nocturnal asthma by increasing compliance and providing better asthma control. In addition, the lower daytime theophylline levels produced by this preparation may also reduce long-term adverse effects on behavior and cognition.

Adolescent↗