PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

Primary aim:To evaluate the efficacy of Pulmonarom in the decrease of interleukin-4/interferon gamma after second period of treatment.Secondary aims: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.

Official Title

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.

Conditions

• Respiratory Tract Infections

Study Type

Interventional

Study Design

Treatment, Randomised, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study.

Further Details

Primary Outcome Measures:

• Decrease of interleukin-4/interferon gamma index at baseline values
  [Time Frame: 60 days, 120 days]
  [Designated as safety issue: No]

Secondary Outcome Measures:

• Adverse events and laboratory evaluation
  [Time Frame: 120 days]
  [Designated as safety issue: Yes]

Study Start

December 2007

Eligibility & Criteria

• Ages Eligible for Study: 6 months to 6 years
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

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 future 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.

Total Enrolment

80

Contact Details

Judith Diaz
Sanofi-Aventis

Location:

Sanofi-Aventis Mexico
Mexico