PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

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

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

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.