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Nedocromil in the Outpatient Management of Asthma
Joseph M. Keenan, MD;
Leonard Bielory, MD;
Patrick C. Flamion, MD;
Linda B. Ford, MD;
Martin Murcek, MD;
Dennis R. Pyszczynski, MD;
Jay Selcow, MD;
Anthony Silvagni, DO, PharmD;
Martha Tarpay, MD;
Myron J. Zitt, MD
Arch Fam Med. 1995;4(10):835-841.
Abstract
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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.
Author Affiliations
From the University of Minnesota, Minneapolis (Dr Keenan); University of Minnesota Department of Family Practice—New Jersey Medical School, Newark (Dr Bielory); St Mary's Hospital, Evansville, Ind (Dr Flamion); Allergy and Asthma of Midlands, Papillon, Neb (Dr Ford); Jefferson Medical College, Greensburg, Pa (Dr Murcek); the University of Missouri Medical School (Dr Pyszczynski) and the University of Health Sciences (Dr Silvagni), Kansas City; the University of Connecticut and Hartford Hospital, West Hartford (Dr Selcow); Children's Hospital, Oklahoma City, Okla (Dr Tarpay); and the State University of New York—Stony Brook (Dr Zitt). Dr Pyszczynski has served as a paid consultant to Fisons Pharmaceuticals, Rochester, NY. None of the authors has a financial interest in the results of this study.
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