PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00599417
First received: January 11, 2008
Last updated: September 18, 2009
Last verified: September 2009
  Purpose

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 Intervention Phase
Respiratory Tract Infections
Drug: Bacterial Lysates
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Decrease of interleukin-4/interferon gamma index at baseline values [ Time Frame: 60 days, 120 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events and laboratory evaluation [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599417

Locations
Mexico
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Judith Diaz Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00599417     History of Changes
Other Study ID Numbers: BACLY_L_03329
Study First Received: January 11, 2008
Last Updated: September 18, 2009
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Broncho-Vaxom
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014