Common Cold Clinical Trial
Official title:
The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to <14 Years
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.
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
West Penn Allegheny Health System | Allegheny Singer Research Institute, Merck Sharp & Dohme Corp. |
United States,
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 |
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