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OpenTrials
Completed

NCT Number: NCT00599417

PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

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

Completed

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Key information

Conditions

Respiratory Tract Infections Infections Respiratory Tract Diseases

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Col. Coyoacan, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bacterial Lysates

Drug

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

Drug

placebo controlled

Primary outcomes

  1. Decrease of interleukin-4/interferon gamma index at baseline values

    Time frame: 60 days, 120 days

Secondary outcomes

  1. Adverse events and laboratory evaluation

    Time frame: 120 days

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 23, 2008
Registry last updated
Sep 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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