Upper Respiratory InfectionNCT00405509
The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years
An observational study of Upper Respiratory Infection and Common Cold, run by West Penn Allegheny Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Upper Respiratory Infection, Common Cold
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jan 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Male and Female subjects ages 6 to under 14 years with common cold symptoms of less than 24 hours in duration.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
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.
Read the 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.
- Conditions
- Upper Respiratory Infection, Common Cold
- Keywords
- Upper Respiratory Infection, Common Cold
- Medical subject headings
- Respiratory Tract Infections, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Confirmed respiratory virus | Not described | |
| Unconfirmed respiratory infection | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: once a day for 6 days and on day 30
Secondary outcomes (4)
Nasal Secretion Weights
Nasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight
Measured: each day for 5 days
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.
Measured: once a day for six days and on day 30
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.
Measured: once a day for six days and on day 30
Severity of Symptom Score - SNEEZING
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.
Measured: once a day for six days and on Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Upper Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Penn Allegheny Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Deborah Gentile, West Penn Allegheny Health System
- Investigators
- Deborah Gentile, MD, Principal investigator, West Penn Allegheny Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405509
- Sponsor's protocol ID
- RC#4065
- Status last verified
- Jul 2016
- First submitted
- 28 Nov 2006
- Last updated
- 19 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to <14 Years
- ClinicalTrials.gov ID
- NCT00405509
- Acronym / sponsor ID
- RC#4065
- Conditions
- Upper Respiratory Infection, Common Cold
- Keywords
- Upper Respiratory Infection, Common Cold
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- West Penn Allegheny Health SystemUniversity, hospital or other
- Collaborators
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), Merck Sharp & Dohme LLC
- Study start
- Oct 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 30 Nov 2006 (estimated)
- Results
- Posted 30 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Confirmed respiratory virus | – | – |
| Unconfirmed respiratory infection | – | – |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Male and Female subjects ages 6 to under 14 years with common cold symptoms of less than 24 hours in duration.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Nasal Secretion Weights
Time frame: each day for 5 days
Severity of Symptom Scores - COUGH
Time frame: once a day for six days and on day 30
Severity of Symptom Score - NASAL CONGESTION
Time frame: once a day for six days and on day 30
Severity of Symptom Score - SNEEZING
Time frame: once a day for six days and on Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Gentile, MD principal investigator
West Penn Allegheny Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Respiratory Infection and Common Cold, run by West Penn Allegheny Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Leukotriene Levels (time frame: once a day for 6 days and on day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.