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Published on: April 6, 2017
Nedocromil in the outpatient management of asthma
J M Keenan1, L Bielory, P C Flamion
1University of Minnesota, Minneapolis, USA.
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.
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