PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Broncho-Vaxom

Criteria

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.