Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | OTHER |
| Merck Sharp & Dohme LLC | INDUSTRY |
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Confirmed respiratory virus | |||
| Unconfirmed respiratory infection |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Severity of Symptom Scores - COUGH |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Male and Female subjects ages 6 to under 14 years with common cold symptoms of less than 24 hours in duration.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deborah Gentile, MD | West Penn Allegheny Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
Not provided
Subjects were recruited from private practice pediatric and family practice offices. Some subjects were recruited via Institutional Review Board (IRB)-approved advertisement.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Confirmed Respiratory Infection | respiratory infection virus type confirmed by assay |
| FG001 | Unconfirmed Respiratory Infection | participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Confirmed Respiratory Infection | participants who had the type of viral infection confirmed by assay |
| BG001 | Unconfirmed Respiratory Infection | participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | pg/ml | once a day for 6 days and on day 30 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Confirmed Respiratory Virus |
Not provided
Not provided
Respiratory viruses were not detected in approximately 2/3 of the enrolled subjects. Future studies will need to apply more stringent inclusion/exclusion criteria to circumvent this problem.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Gentile, MD | Allegheny General Hospital | 412-359-6654 | dgentile@wpahs.org |
Not provided
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Buccal brushing for genotyping
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 |
| 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 |
| 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. | once a day for six days and on Day 30 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Nasal Secretion Weights | Nasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight | Posted | Mean | Standard Deviation | grams | each day for 5 days |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | once a day for six days and on day 30 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | once a day for six days and on day 30 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | once a day for six days and on Day 30 |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Unconfirmed Respiratory Infection | 0 | 22 | 0 | 22 |
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| Day 4 |
|
| Day 5 |
|
| Day 6 |
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
| Day 6 |
|
| Day 30 |
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
| Day 6 |
|
| Day 30 |
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
| Day 6 |
|
| Day 30 |
|