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PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

NCT00599417 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2009-09-21

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Judith Diaz · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Mexico

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00599417 on ClinicalTrials.gov