Ipratropium nasal spray in children with perennial rhinitis.
OBJECTIVE
To compare the efficacy and safety of ipratropium nasal spray and placebo administered twice each day for 4 weeks in pediatric patients with perennial rhinitis who had rhinorrhea as a major complaint.


METHODS
This was a multicenter, double-blind, parallel group study. Patients aged 6 to 18 years with symptoms of perennial nonallergic (PNAR) or perennial allergic rhinitis (PAR) were randomized to receive ipratropium (42 micrograms per nostril) or placebo nasal spray, double-blind, twice each day for 4 weeks. Efficacy was evaluated by nasal symptoms, especially anterior rhinorrhea, and quality of life. Previous caregivers for rhinitis and medications used in the past were also evaluated.


RESULTS
A total of 202 patients were empanelled, 162 with PAR, 40 with PNAR; of these 151 with mild-severe rhinorrhea were evaluated for efficacy. Treatment with ipratropium reduced symptoms of rhinorrhea primarily in patients with PNAR. In patients with PAR this response was less pronounced, and was seen as a modest decrease in the severity of rhinorrhea noted in the first 2 weeks of treatment. Quality of life assessments confirmed that rhinorrhea was bothersome to these pediatric patients, and suggested that treatment with ipratropium nasal spray was associated with an improvement, especially in the patients with PNAR. There were few adverse events; these were similar in the two treatment groups.


CONCLUSIONS
Ipratropium nasal spray 0.03% administered at a dose of 42 micrograms/nostril bid is a safe and effective new therapy for control of anterior rhinorrhea in pediatric patients with PNAR. Twice daily administration is adequate for patients with PNAR, but patients with PAR might benefit from more frequent administration (e.g., tid).
Meltzer
E O
EO
Allergy & Asthma Medical Group & Research Center, APC; San Diego, California, USA.
Orgel
H A
HA
Biondi
R
R
Georgitis
J
J
Milgrom
H
H
Munk
Z
Z
Van Bavel
J
J
Wood
C C
CC
Drda
K
K
D000280:Administration, Inhalation; D000293:Adolescent; D000336:Aerosols; D002559:Cerebrospinal Fluid Rhinorrhea / Q000150:complications; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D009241:Ipratropium / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D009297:Nasal Mucosa / Q000166:cytology / Q000378:metabolism; D010919:Placebos; D011788:Quality of Life; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*
D000336:Aerosols; D010919:Placebos; D009241:Ipratropium