Use of 0.06% ipratropium bromide nasal spray in children aged 2 to 5 years with rhinorrhea due to a common cold or allergies.
BACKGROUND
Rhinorrhea from common colds or allergies in children is similar to that in adults, yet there are few data on the use of ipratropium bromide nasal spray in children younger than 5 years.


OBJECTIVE
To evaluate the safety and efficacy of 0.06% ipratropium bromide nasal spray in 2- to 5-year-old children with rhinorrhea from a common cold or allergies.


METHODS
A total of 230 children (43 with common colds and 187 with allergies) participated in an open-label, multicenter study. Patients with a common cold received ipratropium bromide nasal spray (84 microg per nostril) 3 times daily for 4 days; those with allergies received ipratropium bromide nasal spray (42 microg per nostril) 3 times daily for 14 days.


RESULTS
In the common cold and allergy groups, 91% and 90% of the parents, respectively, found that ipratropium bromide was either "very useful" or "somewhat useful." Furthermore, 67% and 91% of parents in the common cold and allergy groups, respectively, found that administration of a nasal spray was either "extremely easy" or "very easy." Symptom scores were improved from baseline in both groups. The nasal spray was well tolerated and was not associated with serious or systemic anticholinergic adverse effects. Most adverse events were infrequent and mild to moderate, and study discontinuation due to an adverse event occurred in less than 3% of patients.


CONCLUSIONS
The 0.06% ipratropium bromide nasal spray, 42 or 84 microg per nostril 3 times daily, is easy to administer, safe, and effective for the control of rhinorrhea in children aged 2 to 5 years with a common cold or allergies.
Kim
Kenneth T
KT
West Coast Clinical Trials Inc, Long Beach, California, USA.
Kerwin
Edward
E
Landwehr
Lawrence
L
Bernstein
Jonathan A
JA
Bruner
Dawn
D
Harris
Duane
D
Drda
Kristin
K
Wanger
Jack
J
Wood
Chester C
CC
D000281:Administration, Intranasal; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002675:Child, Preschool; D018680:Cholinergic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D003139:Common Cold / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D009241:Ipratropium / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D009297:Nasal Mucosa / Q000378:metabolism; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000503:physiopathology; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology
D001993:Bronchodilator Agents; D018680:Cholinergic Antagonists; D009241:Ipratropium