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

• ClinicalTrials.gov Identifier: NCT00405509
• Recruitment Status: Completed
• First Posted: November 30, 2006
• Results First Posted: September 30, 2014
• Last Update Posted: August 19, 2016
• Sponsor: West Penn Allegheny Health System
• Collaborators: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute); Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Deborah Gentile, West Penn Allegheny Health System

Study Description

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.

Condition or disease
Upper Respiratory Infection; Common Cold

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 33 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to <14 Years
• Study Start Date: October 2006
• Actual Primary Completion Date: January 2009
• Actual Study Completion Date: January 2009

Groups and Cohorts

Group/Cohort
Confirmed respiratory virus
Unconfirmed respiratory infection

Outcome Measures

Primary Outcome Measures :

1. Local Leukotriene Levels [ Time Frame: once a day for 6 days and on day 30 ]
   nasal secretions were collected once a day for the first six days of the respiratory infection and on day 30 then measured for leukotriene levels

Secondary Outcome Measures :

1. Nasal Secretion Weights [ Time Frame: each day for 5 days ]
   Nasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight
2. Severity of Symptom Scores - COUGH [ Time Frame: once a day for six days and on day 30 ]
   Cough symptoms were rated by the participant each day for 6 days and on day 30. Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.
3. Severity of Symptom Score - NASAL CONGESTION [ Time Frame: once a day for six days and on day 30 ]
   nasal congestion symptoms were rated by the participant once a day for six days and on day 30. Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.
4. Severity of Symptom Score - SNEEZING [ Time Frame: once a day for six days and on Day 30 ]
   Sneezing symptoms were rated by participants once a day for six days and on Day 30, symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.

Biospecimen Retention:   Samples With DNA

Buccal brushing for genotyping

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 13 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Male and Female subjects ages 6 to 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 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.

Contacts and Locations

Locations

United States, Pennsylvania

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

Sponsors and Collaborators

West Penn Allegheny Health System

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

Merck Sharp & Dohme Corp.

Investigators

• Principal Investigator: Deborah Gentile, MD; West Penn Allegheny Health System

More Information

• Responsible Party: Deborah Gentile, Director of Research, Allergy and Asthma Institute, West Penn Allegheny Health System
• ClinicalTrials.gov Identifier: NCT00405509
• Other Study ID Numbers: RC#4065
• First Posted: November 30, 2006
• Results First Posted: September 30, 2014
• Last Update Posted: August 19, 2016
• Last Verified: July 2016

Keywords provided by Deborah Gentile, West Penn Allegheny Health System:

Upper Respiratory Infection; Common Cold

Additional relevant MeSH terms:

Infection; Communicable Diseases; Respiratory Tract Infections; Common Cold; Respiratory Tract Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases