Back to resultsPulmonarOM (Bacterial Lysates) in Respiratory Tract Infections
Primary Purpose
Respiratory Tract Infections
Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Bacterial Lysates
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Tract Infections
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.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Decrease of interleukin-4/interferon gamma index at baseline values
Secondary Outcome Measures
Adverse events and laboratory evaluation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00599417
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bacterial Lysates
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo controlled
Primary Outcome Measure Information:
Title
Decrease of interleukin-4/interferon gamma index at baseline values
Time Frame
60 days, 120 days
Secondary Outcome Measure Information:
Title
Adverse events and laboratory evaluation
Time Frame
120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Diaz
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Col. Coyoacan
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections
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