PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

September 18, 2009 updated by: Sanofi

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Col. Coyoacan, Mexico
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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 Comparator: 2
Drug: placebo
placebo controlled

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease of interleukin-4/interferon gamma index at baseline values
Time Frame: 60 days, 120 days
60 days, 120 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events and laboratory evaluation
Time Frame: 120 days
120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Judith Diaz, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 11, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Estimate)

September 21, 2009

Last Update Submitted That Met QC Criteria

September 18, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BACLY_L_03329

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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