PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

Phase 4

Completed

• Conditions: Respiratory Tract Infections
• Interventions: Drug: Bacterial Lysates; Drug: placebo

• Registration Number: NCT00599417
• Lead Sponsor: Sanofi

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-11
• Study First Posted: 2008-01-23
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-18
• Last Update Posted: 2009-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Bacterial Lysates	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
Decrease of interleukin-4/interferon gamma index at baseline values	60 days, 120 days

Secondary Outcome Measures

Name	Time	Method
Adverse events and laboratory evaluation	120 days

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇲🇽 Col. Coyoacan, Mexico