PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

Sanofi

Status and phase: Completed; Phase 4

Conditions: Respiratory Tract Infections

Treatments: Drug: Bacterial Lysates; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00599417

BACLY_L_03329

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Bacterial Lysates

2

Placebo Comparator group

Treatment:

Drug: placebo