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NCT Number: NCT00405509

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

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Key information

Conditions

Upper Respiratory Infection Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

West Penn Allegheny Health System

Other

Collaborators

  • Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 30, 2006
Registry last updated
Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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