Clinical trial NCT00405509: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Respiratory Infection
Common Cold
Keywords: Upper Respiratory Infection
Common Cold
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
Collaborators: name: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
name: Merck Sharp & Dohme LLC
First posted: 2006-11-30
Enrollment: 33
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Local Leukotriene Levels
timeFrame: once a day for 6 days and on day 30
Secondary outcomes:
measure: Nasal Secretion Weights
timeFrame: each day for 5 days
measure: Severity of Symptom Scores - COUGH
timeFrame: once a day for six days and on day 30
measure: Severity of Symptom Score - NASAL CONGESTION
timeFrame: once a day for six days and on day 30
measure: Severity of Symptom Score - SNEEZING
timeFrame: once a day for six days and on Day 30
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: West Penn Allegheny Health System
name: Deborah Gentile, MD
role: PRINCIPAL_INVESTIGATOR
References: