PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections
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
1 other identifier
interventional
80
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 11, 2008
CompletedFirst Posted
Study publicly available on registry
January 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedSeptember 21, 2009
September 1, 2009
9 months
January 11, 2008
September 18, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Decrease of interleukin-4/interferon gamma index at baseline values
60 days, 120 days
Secondary Outcomes (1)
Adverse events and laboratory evaluation
120 days
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- Patients with history of relapse or recurrence of respiratory infections or disease
- Patients with chronic respiratory disease as asthma, bronchitis or sinusitis
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Judith Diaz
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 11, 2008
First Posted
January 23, 2008
Study Start
December 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
September 21, 2009
Record last verified: 2009-09