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Abstract
At four medical centers, 98 patients with stable asthma, histories of nighttime awakening at least three times weekly and nighttime declines of pulmonary function of at least 15%, who were not taking oral adrenergic agonists, were randomly treated with either oral repeat-action albuterol sulfate (Proventil® Repetabs®), 4 mg in the morning and 4–16 mg at bedtime, or a placebo for 2 weeks. All patients were required to have nocturnal symptoms of asthma, with prior use of bronchodilators other than oral adrenergic agonists to be eligible for the study.
The patients maintained a diary of asthma symptom scores and recorded peak flow rates at home at bedtime and in the morning. They had spirometry (FEV1 FVC, and PEFR) after a 1-week baseline stabilization period, and after 1 and 2 weeks of double-blind oral therapy as noted above. Efficacy was evaluated by changes in the bedtime and morning peak flow rates, changes in the number of nighttime awakenings, results of office spirometry testing, and by physician and patient global evaluations of response to therapy.
Of the 98 patients in the study, 47 received oral albuterol, and 51 received placebo. The patients on albuterol had a statistically significant reduction in the number of nighttime awakenings (p ≤ 0.01), as compared with the patients on placebo; this included both the average number of awakenings per week (p = 0.04), and the mean number of nights with awakenings per week (p = 0.04). The albuterol group had a statistically significant reduction in the number of nights with a greater than 15% dip in peak flow between bedtime and morning (p ≤ 0.05). The active treatment group showed a statistically significant improvement in mean FEV1 over the period of the study (p = 0.02), and significant improvement in their global assessment (p < 0.01), both by the patients and the physicians. Their daily total symptom scores of asthma also were statistically significantly improved over the placebo group (p = 0.03). Tremor was noted more frequently in the albuterol group than in the placebo group (34 vs 4%; p < 0.01); only 2 patients in the albuterol group stopped treatment because of side effects, however. In summary, we find that repeat-action albuterol sulfate (Proventil® Repetabs®) is effective for the treatment of nocturnal symptoms of asthma, with improvement in symptom scores and pulmonary function parameters.