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PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00599417
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : September 21, 2009
Sponsor:
Information provided by:
Sanofi

Study Description
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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

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Drug: Bacterial Lysates Drug: placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Decrease of interleukin-4/interferon gamma index at baseline values [ Time Frame: 60 days, 120 days ]

Secondary Outcome Measures :
  1. Adverse events and laboratory evaluation [ Time Frame: 120 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599417


Locations
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Mexico
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Judith Diaz Sanofi
More Information
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Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00599417    
Other Study ID Numbers: BACLY_L_03329
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: September 21, 2009
Last Verified: September 2009
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
 Respiratory Tract Diseases
Broncho-Vaxom
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs