Intranasal fluticasone propionate does not prevent acute otitis media during viral upper respiratory infection in children.
BACKGROUND
Acute otitis media (AOM) is the most common complication of a viral upper respiratory infection (URI) in children. The virus-induced host inflammatory response in the nasopharynx plays a key role in the pathogenesis of AOM. Suppression of this inflammatory process might prevent the development of AOM as a complication.


OBJECTIVE
We sought to assess the effect of intranasally administered fluticasone propionate on prevention of AOM during a viral respiratory infection.


METHODS
A total of 210 children (mean age, 2.1 years; range, 0.7-3.9 years) with normal middle ear status and URI of 48 hours' duration or less were randomly allocated to receive either fluticasone (100 microg twice daily) or placebo for 7 days. The specific viral cause of the infection was determined from nasopharyngeal aspirates obtained at the first visit. The children were re-examined at the end of the 7-day medication period.


RESULTS
In the fluticasone group AOM developed in 40 (38.1%) of 105 children compared with 29 (28.2%) of 103 children receiving placebo (P =.13). The viral cause of the respiratory infection was determined in 167 (86.1%) of 194 children from whom a nasopharyngeal aspirate was obtained. In children with rhinovirus infection, AOM developed significantly more often in the fluticasone group (45.7%) than in the placebo group (14.7%, P =.005).


CONCLUSIONS
Intranasally administered fluticasone does not prevent the development of AOM during URI but may increase the incidence of AOM during rhinovirus infection.
Ruohola
A
A
Department of Pediatrics, Turku University Hospital, Finland.
Heikkinen
T
T
Waris
M
M
Puhakka
T
T
Ruuskanen
O
O
D000208:Acute Disease; D000281:Administration, Intranasal; D000730:Androstadienes / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D005260:Female; D000068298:Fluticasone; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000517:prevention & control*; D012141:Respiratory Tract Infections / Q000150:complications* / Q000821:virology*
D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D000068298:Fluticasone