Prophylactic management of children at risk for recurrent upper respiratory infections: the Preventia I Study.
BACKGROUND
Given the morbidity and mortality of asthma and the recent dramatic increase in its prevalence, pharmacologic prophylaxis of this disease in children at risk would represent a major medical advance.


OBJECTIVE
The Preventia I Study was designed to evaluate the efficacy and long-term safety of loratadine in reducing the number of respiratory infections in children at 24 months. A secondary objective was to investigate the benefit of loratadine treatment in preventing the onset of respiratory exacerbations.


METHODS
Preventia I was a randomized placebo-controlled study involving 22 countries worldwide. The children were 12-30 months of age at enrollment and had experienced at least five episodes of ENT infections, and no more than two episodes of wheezing during the previous 12 months. Phase I was a 12-month double-blind period during which the children were treated with loratadine 5 mg/day (2.5 mg/day for children</=24 months of age) or placebo. Phase II was a double-blind follow-up period without study medication.


RESULTS
Of the 412 children enrolled, 342 and 310 completed Phase I and Phase II, respectively. The results showed a significant decrease in the number of infections in the whole population of children. However, no difference was observed between the loratadine and placebo group. When considering secondary end-points, loratadine was shown to reduce the number of respiratory exacerbations during the treatment phase. None of the 204 children who received loratadine discontinued the study because of drug-related events. Loratadine treatment was not more sedative than placebo and was not associated with cardiovascular events.


CONCLUSIONS
The strong decrease in the rate of infections in the children at risk of recurrent infections, while not being influenced by loratadine treatment, should encourage future reflection in terms of prophylactic management. This study also confirms the long-term safety of loratadine and its metabolites in young children.
Grimfeld
A
A
Hôpital Armand Trousseau, Paris, France. alain.grimfeld@trs.ap-hop-paris.fr
Holgate
S T
ST
Canonica
G W
GW
Bonini
S
S
Borres
M P
MP
Adam
D
D
Canseco Gonzalez
C
C
Lobaton
P
P
Patel
P
P
Szczeklik
A
A
Danzig
M R
MR
Roman
I
I
Bismut
H
H
Czarlewski
W
W
D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000517:prevention & control; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D039563:Histamine H1 Antagonists, Non-Sedating / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D017336:Loratadine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D012008:Recurrence; D012141:Respiratory Tract Infections / Q000517:prevention & control*; D016896:Treatment Outcome
D018926:Anti-Allergic Agents; D039563:Histamine H1 Antagonists, Non-Sedating; D017336:Loratadine