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A van As

Publications and source records attributed to A van As.

At least 19 recordsLinked to original sources

A comparative study of the clinical efficacy of nedocromil sodium and placebo. How does cromolyn sodium compare as an active control treatment?

Nedocromil sodium and cromolyn sodium are the only two currently available nonsteroid anti-inflammatory agents for treatment of asthma. Clinical differences between the two agents remain under continuous investigation with reports differentiating the two on the basis of atopy of the patient and reversibility of bronchoconstriction. This study investigated the efficacy of nedocromil sodium (4 mg, qid) for treatment of mild-to-moderate asthma in comparison to placebo using cromolyn sodium (2 mg, qid) as an active control treatment. Patients were primarily allergic asthmatics (with at least 15% reversibility) previously maintained on a regimen of regular bronchodilator therapy. During a 2-week run-in period, the patient's slow-release theophylline therapy was removed, and the patients were randomized to treatment after deterioration of asthma control (asthma symptom summary score of 3 for 7 of the 14 days). After 8 weeks of treatment, patients were returned to as occasion requires bronchodilator therapy, as per the 2-week baseline period. The results demonstrate that patients treated with nedocromil sodium showed statistically significant improvements during the primary time period (mean weeks 3 through 8) over placebo-treated patients as evidenced by all indexes of asthma symptoms, pulmonary function measures, and decreased bronchodilator reliance (p<0.05). Patients treated with cromolyn sodium demonstrated similar improvements over placebo-treated patients. Comparisons between nedocromil sodium and cromolyn sodium showed the two agents to be comparable in this group of primarily allergic patients with reversible disease. Between-group differences were noted for 3 of the 13 variables (nighttime asthma, FEV1, and forced expiratory flow rate between 25 % and 75% of the FVC) in favor of cromolyn sodium when the data were pooled during the primary time period. The number of patients missing 1 or more days from work/school/regular activity due to asthma was significantly fewer compared with placebo, and favoring nedocromil sodium over cromolyn sodium. No differences were observed among the three treatments for adverse events. This study demonstrated that in primarily allergic patients with reversible airways disease, nedocromil sodium and cromolyn sodium are both significantly more effective than placebo for treatment of mild-to-moderate asthma.

Activities of Daily Living

Fluticasone propionate aerosol for the treatment of adults with mild to moderate asthma. The Fluticasone Propionate Asthma Study Group.

BACKGROUND: Recent emphasis on the control of airway inflammation in asthma highlights the need for safe and effective antiinflammatory agents. Fluticasone propionate is one of the most potent antiinflammatory corticosteroids developed to date. OBJECTIVE: This study assessed the safety and efficacy of fluticasone propionate aerosol in the treatment of mild to moderate asthma. METHODS: Fluticasone propionate aerosol (25, 100, or 500 micrograms twice daily) or placebo was given for as long as 8 weeks to adults with mild to moderate asthma in a randomized, double-blind, parallel-group study. Patients were removed from the study if they showed predefined signs of worsening asthma. RESULTS: Sixty-three percent of placebo-treated patients and 23%, 13%, and 4% of patients treated with fluticasone propionate 25, 100, and 500 micrograms twice daily, respectively, were removed from the study. Mean forced expiratory volume in 1 second, forced vital capacity, and forced expiratory flow at midexpiratory phase at weekly visits throughout the study demonstrated that fluticasone propionate was more efficacious than placebo in maintaining asthma control. Measurements of peak expiratory flow and symptom scores significantly improved and nighttime awakenings and albuterol use to treat symptoms significantly declined in fluticasone propionate-treated groups relative to the placebo-treated group. Differences among fluticasone propionate groups for these variables were not statistically significant. Incidence and severity of adverse events were similar across groups. Fluticasone propionate did not affect morning or stimulated plasma cortisol concentrations, although slight, transient reductions in urinary free cortisol and urinary 17-hydroxy steroids occurred in the group receiving 500 micrograms fluticasone propionate twice daily. CONCLUSION: These data indicate that fluticasone propionate provides safe and effective treatment for mild to moderate asthma.

Administration, Topical

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

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

Dose tolerance study of fluticasone propionate aqueous nasal spray in patients with seasonal allergic rhinitis.

A multicenter, double-blind, parallel-group, dose-tolerance study was conducted to evaluate the safety of fluticasone propionate aqueous nasal spray, a potent new corticosteroid preparation. Ninety-seven adult patients with moderate to severe seasonal allergic rhinitis during the fall weed season received either placebo or fluticasone propionate in doses of 50, 200, or 800 micrograms twice daily for 4 weeks. Safety evaluations included adrenal function evaluation by morning plasma cortisol concentration, response to ACTH stimulation, and 24-hour urinary free cortisol excretion. There was no evidence of effects on adrenal function at any dose. The severity, nature, and frequency of adverse events were similar across all treatment groups, including placebo. Drug-related adverse events were consistent with local nasal irritation. The groups receiving fluticasone propionate showed greater improvement in nasal symptoms (obstruction, rhinorrhea, sneezing, and itching) than did the placebo group. The results demonstrate that fluticasone propionate aqueous nasal spray is safe in doses up to 1600 micrograms per day and effective in the treatment of seasonal allergic rhinitis.

Administration, Intranasal

The effect of exercise on secretory and natural immunity.

Secretory immunity. 1. Intense endurance exercise suppresses salivary immunoglobulins. The exercise-induced decrease is specific for the secretory antibodies IgA and IgM. 2. The suppression of secretory Ig is transitory, lasting at least one hour, and returning to pre-exercise levels by 24 hours after a single bout of severe exercise. These results suggest that anecdotal statements by athletes and their coaches of an increased susceptibility to upper respiratory infection after severe exercise could be related to changes in secretory immunity. Natural immunity. 1. Natural killer activity of PBL is suppressed one hour after intense endurance exercise. This effect is transitory, since activity returns to pre-exercise levels by 24 hours after a single bout of exercise. 2. The decrease in NK lytic activity is due to a decrease in the percentage of NK cells (Leu-11a+ cells). When NK cell activity is expressed on a per cell basis, it appears that activity is enhanced after exercise.

Adult

A group comparative study of the safety and efficacy of nedocromil sodium (Tilade) in reversible airways disease: a preliminary report.

Nedocromil sodium in a dose of 4 mg b.i.d. or q.i.d. by inhalation was used to treat asthmatic patients in a double-blind, placebo-controlled, randomized, parallel study. 80 patients (39 active drug and 41 placebo) received q.i.d. dosage and 87 patients (45 active drug and 42 placebo) received b.i.d. dosage. The patients selected were not on oral or inhaled steroids but required oral sustained-release theophylline with or without an inhaled beta-agonist aerosol. There was a significant reduction in daytime asthma symptoms (p = 0.04) and asthma severity (p less than 0.01) 6 weeks after the onset of therapy in the nedocromil sodium q.i.d. treated group as compared with placebo. In the nedocromil sodium b.i.d. treated group, the following variables showed statistically significant improvements compared with placebo: daytime and night-time asthma (p = 0.002 in both instances), wheezing assessed by auscultation (p = 0.03) and overall asthma severity (p less than 0.01). All these variables showed improvements within 2 weeks of the onset of therapy and became statistically significant at 6 weeks. Side-effects were minor and occurred only in a small number of patients. It can be concluded from this study that nedocromil sodium is a safe and effective drug in the management of asthma.

Adrenal Cortex Hormones

Body surface area of the Chacma baboon (Papio ursinus).

The body surface area (BSA) of 11 Chacma Baboons has been determined by a coating method using plaster of Paris. The relationship between BSA (Cm2) and mass (g) is adequately described by the simple Meeh formula A = (12.7) M2/3. The inclusion of an additional variable, such as length, is not indicated by the data. The difference in K values between species and individuals is postulated to be determined by variations in body density rather than other factors.

Animals

A comparative assessment of carbuterol, fenoterol and hexoprenaline in allergic asthma.

Carbuterol tablets (2,0 mg) were compared with the tablets of fenoterol (2,5 mg) and hexoprenaline (1 mg). The three drugs were shown to be equally effective for a period of 4 hours, but carbuterol and fenoterol exerted a statistically significant bronchodilating action for 7 and 8 hours respectively, while the action of hexoprenaline lasted for 4 hours in the majority of patients. The aerosols of carbuterol (200 mg) and fenoterol (400 mg) appeared to be similar in inhibiting exercise-induced asthma, whereas hexoprenaline (200 mg) did not appear to be as effective.

Adolescent

Fat embolism.

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Blood Coagulation Disorders