Primary aim:To evaluate the efficacy of Pulmonarom in the decrease of interleukin-4/interferon gamma after second period of treatment.Secondary aims: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.
Prospective, Pivotal Unicentre, Randomized Double-Bind, Placebo-Controlled Study, to Evaluate Efficacy and Safety of Bacterial Lysates (Pulmonarom) in the Prevention of Respiratory Tract Infections.
- Respiratory Tract Infections
Treatment, Randomised, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study.
Primary Outcome Measures:
- Decrease of interleukin-4/interferon gamma index at baseline values
[Time Frame: 60 days, 120 days]
[Designated as safety issue: No]
Secondary Outcome Measures:
- Adverse events and laboratory evaluation
[Time Frame: 120 days]
[Designated as safety issue: Yes]
Eligibility & Criteria
- Ages Eligible for Study: 6 months to 6 years
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No
- Patients with history of relapse or recurrence of respiratory infections or disease
- Patients with chronic respiratory disease as asthma, bronchitis or sinusitis
- Patients unlikely to comply with the protocol, for example, uncooperativeness or impossibility to return for future 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
The above information is not intended to contain all considerations relevant to a patient’s potential participation in a clinical trial.
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