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Eighteen patients with chronic urticaria were evaluated concerning the benefit of oral sympathomimetic therapy. No significant differences could be found between the sympathomimetic agent (terbutaline) and a placebo in the various clinical parameters evaluated. The authors conclude that the efficacy of this drug is doubtful in the treatment of chronic urticaria.

Bioavailability and theophylline level variability were compared between a standard theophylline elixir and a new sustained release theophylline tablet. The results demonstrate a good bioavailability and a reduced dosage interval with less theophylline level variability for the sustained release tablet, administered every 12 hours, than with the immediate release product, every six hours.

To facilitate administration of sustained-release theophylline in pediatric patients fourteen children with asthma were studied using intact capsules versus the granular contents in apple sauce. In a cross-over study during multiple dose intervals the effectiveness of this administration technique was demonstrated for maintaining bioavailability and sustained-release characteristics.

Plasma theophylline concentrations were measured in 20 adults after single doses of 8 mg/kg of each of six oral sustained-release theophylline preparations. Twelve subjects were studied in a multiple-dose trial. Comparison of bioavailability and absorption characteristics suggest usefulness of some of these products for the purpose of maintaining safe and effective blood levels with twice-a-day dosing.

A double-blind, crossover study was performed with a new topical aerosol steroid, flunisolide, administered every 12 hours over a period of eight weeks to 36 adult patients with perennial allergic rhinitis. During the treatment period the majority of patients had significant relief of symptoms as compared with the placebo period. Most prominent improvement occurred with the symptoms of nasal stuffiness, sneezing, rhinorrhea and the number of times patients had to blow their noses. Best results were obtained in patients with higher degrees of atopy. Side effects were minimal and limited to nasal irritation in some patients. Criteria for optimal patient selection are discussed and an explanation for the lack of systemic effects of aerosolized use of the newer corticosteroids is given.

Theophylline levels were measured on 63 plasma samples by both high pressure liquid chromatography and Seralyzer methods with excellent correlation. Seralyzer results were obtained quickly and easily in an office setting and offered the additional advantage of allowing accurate measurements on finger-stick samples.

Procaterol hydrochloride, a new potent beta-2 agonist drug, was evaluated for effects of food absorption, onset of action, and efficacy in a single-dose non-blinded placebo controlled crossover design in 18 subjects. Three diet conditions, separated by a three to seven day washout period, were used and compared to a placebo treatment. The diets were standardized and included high fat, low fat, and a fasting condition. Spirometric determinations and vital signs were obtained at 0, 15, 30 minutes, and at one, two, four, six, eight hours post-dose to evaluate therapeutic availability since no technique for measuring serum levels of procaterol hydrochloride is currently available. Spirometry results indicated significant improvement in pulmonary function during all diet conditions except with the placebo treatment. A delay in onset of action was seen in the low fat diet and to a certain extent in the high fat diet as compared to the fasting condition. There was no effect of diet on procaterol hydrochloride's peak response or duration of action with improvement in pulmonary function demonstrated for up to eight hours. Tremor and headache were the most frequent side effects, and were mild and transient. No significant effects were noted in electrocardiograms, heart rate, or blood pressure. An elevation in serum glucose was seen in three subjects during the fasting challenge and was felt to be secondary to the beta-agonist effects of procaterol hydrochloride. Procaterol was found to be an effective drug with a delayed onset of action when administered with food, but no effect on subsequent efficacy or duration of action.

The purpose of this study was to compare nebulized terbutaline 5 mg vs. subcutaneous epinephrine (1/1000, 0.3 cc) in the treatment of acute exacerbations of asthma in adult patients. Patients with a known diagnosis of asthma, who presented to the investigators in acute respiratory distress, without any previous adrenergic agents for six hours, were the subjects for this study. There were 33 patients enrolled in the study between 16 and 64 years of age. The results indicate both treatment groups gave significant increases in pulmonary function at all times when compared to baseline (p less than 0.001). Nebulized terbutaline and subcutaneous epinephrine appeared equally effective in the treatment of acute exacerbations of asthma, without significant differences in bronchodilator effectiveness or side effects.

Recently some concern has been expressed of the effect of diet on the metabolism of theophylline. This brief trial in normal healthy adults observed the effect of fasting, high fat, low fat, and liquid fat/low carbohydrate diet on the metabolism of a sustained-release theophylline preparation (Theo-Dur). On analysis of the mean theophylline level values, there were no significant differences in the theophylline levels between the diets. However, in certain individuals there were differences in the theophylline absorption rates between diets. No consistent pattern was seen.

Beta agonists are a primary drug of choice in the treatment of asthma. Nevertheless, there are significant concerns about side effects in using these medications, especially in certain disease states, in higher dosages, and in severe asthma episodes. Proper patient evaluations and monitoring can reduce significantly these side effects and reduce their health consequences.

This study evaluated the compliance differences between administration of theophylline at six- and 12-hour intervals in a pediatric outpatient population. Compliance was statistically better with the sustained release tablets than with the short acting tablets.

Twenty-one adult chronic asthmatic patients were studied while taking a 12-hour sustained-action theophylline tablet. Pulmonary function testing and serum theophylline levels were monitored for 12 weeks, including testing every two hours over one dosing interval on the final day of the study. Results indicate the preparation tested produced sustained stable theophylline levels for a full 12 hours, with pulmonary function also remaining elevated and stable during this period. There was minimal toxicity reported over the 12-week period and no evidence of tolerance.

This double-blind parallel group study evaluated ketotifen 1 mg bid versus placebo in the treatment of 30 adult seasonally allergic asthmatics during the course of the spring pollen season. Those individuals on placebo had a fall in FEV1 through the pollen season, those on Ketotifen generally did not, and some individuals, in fact, showed improvement. Those patients receiving ketotifen had fewer allergic symptoms, better exercise tolerance, and in general had a better spring. This study demonstrated that ketotifen may have some benefit in the treatment of adult allergic asthma.