Respiratory Tract Infections
Conditions
Brief summary
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
Interventions
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
DRUGplacebo
placebo controlled
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
* Patients with history of relapse or recurrence of respiratory infections or disease * Patients with chronic respiratory disease as asthma, bronchitis or sinusitis
Exclusion criteria
* Patients unlikely to comply with the protocol, for example, uncooperativeness or impossibility to return for follow-up visits * Patients who are participating or who have participated in another clinical trial during the previous 3 months * Patients who have received immunology response stimulants during the previous 30 days * Hypersensitivity The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease of interleukin-4/interferon gamma index at baseline values | 60 days, 120 days |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and laboratory evaluation | 120 days |
Countries
Mexico
Outcome results
None listed