Primary \- To evaluate the efficacy of Pulmonaron in the decrease of interleukin-4/interferon gamma after second period of treatment Secondary * To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract infections symptoms through patient evaluation of fever or respiratory presence after second period of treatment * To evaluate loss of working or study days after second period of treatment * To evaluate the safety and tolerability of Pulmonarom in the population under study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Bacterial Lysates ampoules 3 mL, oral route, daily for 10 days, followed by 30 days free of medication and then 10 days of administration of the drug
placebo controlled
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Decrease of interleukin-4/interferon gamma index at baseline values
Time frame: 60 days, 120 days
Adverse events and laboratory evaluation
Time frame: 120 days
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