PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00599417

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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-Aventis:

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 ]

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

Arms	Assigned Interventions
1: Experimental	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
2: Placebo Comparator	Drug: placebo placebo controlled

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.

Contacts and Locations

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

Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Judith Diaz

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	BACLY_L_03329
Study First Received:	January 11, 2008
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00599417
Health Authority:	Mexico: Ministry of Health

Study placed in the following topic categories:

Bacterial lysate
Respiratory Tract Diseases
Respiratory Tract Infections

Additional relevant MeSH terms:

Communicable Diseases
Immunologic Factors
Physiological Effects of Drugs

Adjuvants, Immunologic
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009