The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years

Official Title: “The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to <14 Years”

This study examines the cold processes of children aged 6 to <14. Children will be seen by the study staff 6 days in a row during the course of their naturally-acquired colds. Nasal secretions will be examined for chemicals that the body creates during a cold. Skin cells will be collected by brushing the inside of the child's cheek with a small brush. The cells will be examined for genes that may hold control the creation of these chemicals.

Leukotrienes are chemicals that are naturally made by your body. Leukotrienes are increased in the bodies of adults and children with asthma and allergies and cause some of the symptoms of these diseases. Leukotrienes are increased in the bodies of adults who have common colds and are believed to cause some of the symptoms of the common cold. It is not known if increases in leukotrienes are related to the symptoms of the common cold in children. There are also genes that may control levels of leukotrienes and other chemicals in your body during the common cold. If you enroll your child in this study, he/she will be tested for allergies and for genes that may control the levels of leukotrienes and other chemicals.

STUDY DESIGN:

There will be 40 subjects enrolled into the study between the ages of 6 to < 14 years of age. However, approximately 80 participants may have to sign the consent form and undergo screening activities in order enroll these 40 subjects. The study will last approximately 1 month and will require you and your child to return to our clinic approximately 7 times over the study duration. You and your child will be required to return to our clinic six days in a row for testing.

Testing will include skin testing for allergies, nasal secretion collection, and skin cell collection.

Inclusion Criteria:

• Children 6 to <14 years of age.
• Common cold symptoms for less than 24 hours.
• At least 2 of the following 9 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratch throat, and sneezing.

Exclusion Criteria:

• Investigational medication in past 30 days.
• History of persistent asthma or other chronic diseases.
• Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction.
• Patients with evidence of significant nasal septal deviation.
• Patients with a positive rapid antigen test for streptococcal infection.
• Common cold symptoms for more than 24 hours.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 13 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: West Penn Allegheny Health System Other

Overall Clinical Trial Officials and Contacts

Deborah Gentile, MD Principal Investigator West Penn Allegheny Health System  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00405509

Study ID Number: RC#4065

ClinicalTrials.gov Identifier: NCT00405509

Health Authority: United States: Institutional Review Board