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
|Condition or disease|
|Upper Respiratory Infection Common Cold|
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.
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 Type :||Observational|
|Actual Enrollment :||33 participants|
|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|
|Confirmed respiratory virus|
|Unconfirmed respiratory infection|
- 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
- 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
- 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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405509
|United States, Pennsylvania|
|Allegheny General Hospital|
|Pittsburgh, Pennsylvania, United States, 15212|
|Principal Investigator:||Deborah Gentile, MD||West Penn Allegheny Health System|