PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

Respiratory Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599417
• Other study ID #: BACLY_L_03329
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2008
• Last updated: September 18, 2009
• Start date: December 2007
• Est. completion date: September 2008

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Respiratory Tract Infections

Intervention

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
• placebo
placebo controlled

Locations

Country	Name	City	State
Mexico	Sanofi-Aventis Administrative Office	Col. Coyoacan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of interleukin-4/interferon gamma index at baseline values		60 days, 120 days	No
Secondary	Adverse events and laboratory evaluation		120 days	Yes