Nedocromil sodium is more effective than cromolyn sodium for the treatment of chronic reversible obstructive airway disease.

In a multicenter, double-blind, group comparative trial, the efficacy of nedocromil sodium (nedocromil, 4 mg, four times daily [qid]), cromolyn sodium (2 mg, qid), and placebo was compared in patients receiving inhaled beta 2-agonists and inhaled corticosteroids for the treatment of chronic reversible obstructive airway disease. After a 2-week baseline period, 132 patients (8 centers) between the ages of 20 and 75 years entered a 4-week run-in period in which the dose of inhaled corticosteroid was reduced by 50 percent. During the run-in phase, deterioration of symptoms (total symptom score) by ten points qualified patients to enter the 6-week drug trial period. Patients in the nedocromil treatment group showed the most robust and consistent improvements over placebo and cromolyn sodium for all daily dairy variables. Statistically significant improvements over placebo were noted for both active treatment groups for daytime, nighttime, and total symptom score. Symptom scores for nedocromil were statistically significantly improved over both cromolyn sodium and placebo for both daytime and nighttime asthma. Patients treated with nedocromil also demonstrated a significant reduction in the use of nighttime as needed (prn) beta 2-agonists as compared with either the placebo- or cromolyn sodium-treated groups. Only nedocromil-treated patients demonstrated a statistically significant improvement in morning peak expiratory flow rate (PEFR) as compared with placebo. Both nedocromil and cromolyn sodium groups demonstrated statistically significant improvements in afternoon and evening PEFRs. Collectively, the improvements in nighttime symptoms, decreased bronchodilator use, and improved morning PEFR show that patients treated with nedocromil had improved nocturnal symptoms. Pulmonary function tests (FEV1, FVC, PEFR) demonstrated no statistically significant differences between the two active treatments, although trends favored nedocromil for both FEV1 and PEFR. Although symptoms improved in patients treated with cromolyn sodium, the level of symptom control was less than that achieved by nedocromil. As compared with baseline control (regular dose of inhaled steroids), patients treated with nedocromil plus the 50 percent reduced dosage of inhaled corticosteroid consistently demonstrated comparable or better symptom control. Although both active drugs reduced symptoms, nedocromil proved to be more effective than cromolyn sodium for treatment of reversible obstructive airway disease in patients normally well maintained on regimens of low to moderate doses of inhaled corticosteroids.

Psychosocial effects of continuous oxygen therapy in hypoxaemic chronic obstructive pulmonary disease patients.

Twenty six hypoxaemic patients with severe and stable chronic obstructive pulmonary disease (COPD) were treated with continuous domiciliary oxygen for a six month period. The patients were evaluated 1, 3 and 6 months after the start of oxygen therapy. In addition to blood gas analysis, 15 coping skills were evaluated by the patient and by the nurse, who also rated the general activity of the patients. Depression was measured by Beck Depression Inventory (BDI) at the start of the trial and after six months' oxygen therapy. The general psychosocial response was meagre; no significant changes were observed in any psychosocial measures. The response was slightly better in younger and less hypoxaemic patients. We conclude that the psychosocial response to oxygen therapy in severely hypoxaemic COPD patients is limited.

A controlled study on the effect of treatment with cromolyn sodium pressurized aerosol on bronchial reactivity in patients with asthma.

The effect of cromolyn sodium (CS) pressurized aerosol on bronchial hyperreactivity was assessed by comparison with placebo in a double-blind crossover study of 14 adult patients with clinically stable asthma. The trial was performed in a cold climate during the pollen-free winter months and the patient's risk of exposure to clinically relevant allergens was judged to be low. The dose was two puffs, each of 1 mg CS or placebo, four times daily over two successive 4-week periods, the order of treatment being decided by random allocation. No significant difference between treatments was observed in bronchial reactivity to histamine, determined as PC15. There was no difference between treatments with regard to symptoms, which were slight, or daily peak expiratory flow recordings, which showed minimal circadian variation. The results suggest that, although prolonged treatment with CS may decrease bronchial reactivity by reducing airway inflammation secondary to the assault of allergic stimuli, the drug probably has little or no effect on the basal bronchial reactivity in asthma.

Comparison of enprofylline and theophylline for intravenous treatment of acute asthma.

Thirty-nine patients with asthma requiring acute treatment were included in a randomized, double-blind, parallel study which compared the effect of enprofylline (1.0 mg/kg) and theophylline (3.0 mg/kg). The drugs were given intravenously over a period of 10 min. Peak flow (PEF), heart rate and plasma concentrations of the drugs were determined before and after the injection. Both enprofylline and theophylline significantly increased the PEF 30 min after the injection, the mean increases over the baseline values being 21% and 23%, respectively. The clinical effects assessed by the patient and the physician and the significant decreases in heart rate were similar for the two drugs. Side effects were rare. Thus, 1.0 mg/kg of enprofylline was comparable to 3.0 mg/kg of theophylline in the treatment of patients with acute asthma.

Comparison of ketotifen, disodium cromoglycate and placebo in the treatment of adult patients with mild extrinsic asthma.

Sixty-four patients with mild of moderate extrinsic asthma were treated with placebo for 1 month and thereafter with ketotifen (1 mg twice daily, orally), disodium cromoglycate (inhalation of 20 mg, four times daily), or placebo for 2 subsequent months. The trial was performed at four different centres and the treatments were compared using double-blind technique. We found no difference between the effect of ketotifen, disodium cromoglycate and placebo on the patients' daily measurements of evening peak expiratory flow, daily score values or respiratory symptoms of the number of salbutamol puffs required to control symptoms. There was no difference between the treatment groups with regard to the patients' estimates of changes in airway sensitivity to different non-specific stimuli: fumes, tobacco smoke, cold air, and exercise. The only significant effect of DSCG was a minor (4%) increase in the mean morning value for peak expiratory flow. The findings suggest that the addition of ketotifen or disodium cromoglycate to the regimen is unlikely to give further benefit in asthmatic patients, whose symptoms are reasonably well controlled by small doses of bronchodilating drugs.