N/A
N=33
The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years
Upper Respiratory Infection · Common Cold
Bottom Line
View on ClinicalTrials.gov: NCT00405509 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Local Leukotriene Levels — 440; 368; 440; 619 pg/ml
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- West Penn Allegheny Health System
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Leukotriene Levels |
440; 368; 440; 619; 676; 368 | — |
| SECONDARY Nasal Secretion Weights |
2.9; 0.8; 2.0; 0.8; 1.8; 0.8 | — |
| SECONDARY Severity of Symptom Scores - COUGH |
1.5; 0.7; 1.6; 0.7; 1.5; 0.7 | — |
| SECONDARY Severity of Symptom Score - NASAL CONGESTION |
1.5; 1.5; 1.8; 1.4; 1.7; 1.2 | — |
| SECONDARY Severity of Symptom Score - SNEEZING |
0.9; 0.9; 0.9; 0.8; 0.7; 0.7 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00405509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.