NCT00599417

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Not accepted

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

Conditions

• Respiratory Tract Infections

Interventions

Type	Name	Description
DRUG	Bacterial Lysates	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
DRUG	placebo	placebo controlled

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-01-23
• Last updated: 2009-09-21

Locations

1 site across 1 country: Mexico