Nedocromil in the outpatient management of asthma.

Objective: To more closely approximate the use of a nonsteroidal inhaled anti-inflammatory medication for asthma, nedocromil sodium, under actual ambulatory practice conditions.
Design: Large, open-label trial.
Patients: One thousand two hundred one patients from 286 primary care and specialty centers.
Intervention: Four weeks of treatment with nedocromil sodium (4 mg delivered from the valve and 3.5 mg delivered from the mouthpiece of a metered inhalor [2 puffs, four times daily]).
Main Outcome Measures: Asthma symptom scores, peak expiratory flow rate, a lifestyle assessment measures questionnaire, and mean number of days missed per month from work or school.
Results: Statistically significant improvements were seen after 1 and 4 weeks of treatment for cough, daytime and nighttime asthma, morning tightness, peak expiratory flow rate, and all four measured lifestyle assessment factors (P < .001). An additional clinically relevant outcome measure, mean number of days missed per month from work or school, was reduced by 75% (P < .001). No serious adverse reactions were reported.
Conclusion: This study reproduces the high level of efficacy and safety of nedocromil that was previously reported in placebo-controlled clinical studies.