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.


METHODS
Large, open-label trial.


METHODS
One thousand two hundred one patients from 286 primary care and specialty centers.


METHODS
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]).


METHODS
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.


CONCLUSIONS
This study reproduces the high level of efficacy and safety of nedocromil that was previously reported in placebo-controlled clinical studies.
Keenan
J M
JM
University of Minnesota, Minneapolis, USA.
Bielory
L
L
Flamion
P C
PC
Ford
L B
LB
Murcek
M
M
Pyszczynski
D R
DR
Selcow
J
J
Silvagni
A
A
Tarpay
M
M
Zitt
M J
MJ
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D017835:Nedocromil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010366:Peak Expiratory Flow Rate; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D018927:Anti-Asthmatic Agents; D017835:Nedocromil