PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

• ClinicalTrials.gov Identifier: NCT00599417
• Recruitment Status: Completed
• First Posted: January 23, 2008
• Last Update Posted: September 21, 2009
• Sponsor: Sanofi
• Information provided by: Sanofi

Tracking Information

• First Submitted Date: January 11, 2008
• First Posted Date: January 23, 2008
• Last Update Posted Date: September 21, 2009
• Study Start Date: December 2007
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 11, 2008): Decrease of interleukin-4/interferon gamma index at baseline values [ Time Frame: 60 days, 120 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 11, 2008): Adverse events and laboratory evaluation [ Time Frame: 120 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections
• 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

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 Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: 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
• Drug: placebo
  placebo controlled

Study Arms

• Experimental: 1
  Intervention: Drug: Bacterial Lysates
• Placebo Comparator: 2
  Intervention: Drug: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 11, 2008): 80
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2008
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 6 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Mexico

Administrative Information

• NCT Number: NCT00599417
• Other Study ID Numbers: BACLY_L_03329
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Medical Affairs Study Director, sanofi-aventis
• Study Sponsor: Sanofi
• Collaborators: Not Provided

Investigators

• Study Director: Judith Diaz; Sanofi

• PRS Account: Sanofi
• Verification Date: September 2009