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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT00405509
First received: November 28, 2006
Last updated: February 5, 2009
Last verified: February 2009
  Purpose

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.


Condition
Upper Respiratory Infection
Common Cold

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to <14 Years

Resource links provided by NLM:


Further study details as provided by West Penn Allegheny Health System:

Biospecimen Retention:   Samples With DNA

Buccal brushing for genotyping


Enrollment: 36
Study Start Date: October 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   6 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male and Female subjects ages 6-under 14 years with common cold symptoms of less than 24 hours in duration.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405509

Locations
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
West Penn Allegheny Health System
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Deborah Gentile, MD West Penn Allegheny Health System
  More Information

No publications provided

Responsible Party: Deborah Gentile/Principal Investigator, Allegheny General Hospital
ClinicalTrials.gov Identifier: NCT00405509     History of Changes
Other Study ID Numbers: RC#4065
Study First Received: November 28, 2006
Last Updated: February 5, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by West Penn Allegheny Health System:
Upper Respiratory Infection
Common Cold

Additional relevant MeSH terms:
Common Cold
Respiratory Tract Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection

ClinicalTrials.gov processed this record on August 27, 2014