PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

NCT ID: NCT00599417

Last Updated: 2009-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-09-30

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

Conditions

Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

Bacterial Lysates

Intervention Type: DRUG

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

2

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo controlled

Interventions

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

Intervention Type: DRUG

placebo

placebo controlled

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Judith Diaz

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Col. Coyoacan, , Mexico

Countries

Mexico

Other Identifiers

BACLY_L_03329

Identifier Type: -

Identifier Source: org_study_id