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

Common Cold Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405509
• Other study ID #: RC#4065
• Status: Completed
• Phase: N/A
• First received: November 28, 2006
• Last updated: September 24, 2014
• Start date: October 2006
• Est. completion date: January 2009

Study information

• Verified date: September 2014
• Source: West Penn Allegheny Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 13 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Common Cold
• Communicable Diseases
• Infection
• Respiratory Tract Infections
• Upper Respiratory Infection

Locations

Country	Name	City	State
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
West Penn Allegheny Health System	Allegheny Singer Research Institute, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Leukotriene Levels	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	once a day for 6 days and on day 30	No
Secondary	Nasal Secretion Weights	Nasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight	each day for 5 days	No
Secondary	Severity of Symptom Scores - COUGH	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.	once a day for six days and on day 30	No
Secondary	Severity of Symptom Score - NASAL CONGESTION	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.	once a day for six days and on day 30	No
Secondary	Severity of Symptom Score - SNEEZING	Sneezing symptoms were rated by participants once a day for six days and on Day 30	once a day for six days and on Day 30	No