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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

Tracking Information
First Submitted Date  ICMJE January 11, 2008
First Posted Date  ICMJE January 23, 2008
Last Update Posted Date September 21, 2009
Study Start Date  ICMJE December 2007
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2008)
Decrease of interleukin-4/interferon gamma index at baseline values [ Time Frame: 60 days, 120 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2008)
Adverse events and laboratory evaluation [ Time Frame: 120 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Tract Infections
Intervention  ICMJE
  • 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  ICMJE
  • Experimental: 1
    Intervention: Drug: Bacterial Lysates
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2008)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00599417
Other Study ID Numbers  ICMJE BACLY_L_03329
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Judith Diaz Sanofi
PRS Account Sanofi
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP