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

NCT ID: NCT00405509

Last Updated: 2016-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-01-31

Brief Summary

This study examines the cold processes of children aged 6 to less than 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.

Detailed Description

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.

Conditions

Upper Respiratory Infection; Common Cold

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Confirmed respiratory virus

No interventions assigned to this group

Unconfirmed respiratory infection

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Children 6 to < 14 years of age.
• Common cold symptoms for less than 24 hours.
• At least 2 of the following 8 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

OTHER

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

West Penn Allegheny Health System

OTHER

Sponsor Role: lead

Responsible Party

Deborah Gentile

Director of Research, Allergy and Asthma Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Gentile, MD

Role: PRINCIPAL_INVESTIGATOR

West Penn Allegheny Health System

Locations

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

RC#4065

Identifier Type: -

Identifier Source: org_study_id