Common Cold, Upper Respiratory Infection
Conditions
Keywords
Upper Respiratory Infection, Common Cold
Brief 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.
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.
Interventions
None listed
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Leukotriene Levels | 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
| Measure | Time frame | Description |
|---|---|---|
| Severity of Symptom Score - SNEEZING | 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. |
| Severity of Symptom Score - NASAL CONGESTION | 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. |
| Nasal Secretion Weights | each day for 5 days | Nasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight |
| Severity of Symptom Scores - COUGH | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from private practice pediatric and family practice offices. Some subjects were recruited via Institutional Review Board (IRB)-approved advertisement.
Participants by arm
| Arm | Count |
|---|---|
| Confirmed Respiratory Infection participants who had the type of viral infection confirmed by assay | 11 |
| Unconfirmed Respiratory Infection participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed | 22 |
| Total | 33 |
Baseline characteristics
| Characteristic | Total | Confirmed Respiratory Infection | Unconfirmed Respiratory Infection |
|---|---|---|---|
| Age, Categorical <=18 years | 33 Participants | 11 Participants | 22 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous Age | 9.4 years STANDARD_DEVIATION 2.3 | 9.0 years STANDARD_DEVIATION 2.2 | 9.6 years STANDARD_DEVIATION 2.3 |
| Region of Enrollment United States | 33 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 19 Participants | 4 Participants | 15 Participants |
| Sex: Female, Male Male | 14 Participants | 7 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 22 |
| serious Total, serious adverse events | 0 / 11 | 0 / 22 |
Outcome results
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
Time frame: once a day for 6 days and on day 30
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Confirmed Respiratory Infection | Local Leukotriene Levels | Day 3 | 676 pg/ml | Standard Deviation 136.87 |
| Confirmed Respiratory Infection | Local Leukotriene Levels | Day 5 | 737 pg/ml | Standard Deviation 310.34 |
| Confirmed Respiratory Infection | Local Leukotriene Levels | Day 2 | 440 pg/ml | Standard Deviation 48.78 |
| Confirmed Respiratory Infection | Local Leukotriene Levels | Day 6 | 624 pg/ml | Standard Deviation 145.6 |
| Confirmed Respiratory Infection | Local Leukotriene Levels | Day 4 | 992 pg/ml | Standard Deviation 306.84 |
| Confirmed Respiratory Infection | Local Leukotriene Levels | Day 30 | 479 pg/ml | Standard Deviation 120.55 |
| Confirmed Respiratory Infection | Local Leukotriene Levels | Day 1 | 440 pg/ml | Standard Deviation 70.34 |
| Unconfirmed Respiratory Infection | Local Leukotriene Levels | Day 30 | 615 pg/ml | Standard Deviation 127.54 |
| Unconfirmed Respiratory Infection | Local Leukotriene Levels | Day 1 | 368 pg/ml | Standard Deviation 56.54 |
| Unconfirmed Respiratory Infection | Local Leukotriene Levels | Day 2 | 619 pg/ml | Standard Deviation 103.21 |
| Unconfirmed Respiratory Infection | Local Leukotriene Levels | Day 3 | 368 pg/ml | Standard Deviation 75.94 |
| Unconfirmed Respiratory Infection | Local Leukotriene Levels | Day 4 | 300 pg/ml | Standard Deviation 50.51 |
| Unconfirmed Respiratory Infection | Local Leukotriene Levels | Day 5 | 530 pg/ml | Standard Deviation 98.35 |
| Unconfirmed Respiratory Infection | Local Leukotriene Levels | Day 6 | 753 pg/ml | Standard Deviation 185.8 |
Nasal Secretion Weights
Nasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight
Time frame: each day for 5 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Confirmed Respiratory Infection | Nasal Secretion Weights | Day 3 | 2.0 grams | Standard Deviation 0.309 |
| Confirmed Respiratory Infection | Nasal Secretion Weights | Day 5 | 2.0 grams | Standard Deviation 0.309 |
| Confirmed Respiratory Infection | Nasal Secretion Weights | Day 4 | 1.8 grams | Standard Deviation 0.42 |
| Confirmed Respiratory Infection | Nasal Secretion Weights | Day 6 | 1.5 grams | Standard Deviation 0.301 |
| Confirmed Respiratory Infection | Nasal Secretion Weights | Day 2 | 2.9 grams | Standard Deviation 0.618 |
| Unconfirmed Respiratory Infection | Nasal Secretion Weights | Day 6 | 0.8 grams | Standard Deviation 0.188 |
| Unconfirmed Respiratory Infection | Nasal Secretion Weights | Day 2 | 0.8 grams | Standard Deviation 0.176 |
| Unconfirmed Respiratory Infection | Nasal Secretion Weights | Day 3 | 0.8 grams | Standard Deviation 0.276 |
| Unconfirmed Respiratory Infection | Nasal Secretion Weights | Day 4 | 0.8 grams | Standard Deviation 0.21 |
| Unconfirmed Respiratory Infection | Nasal Secretion Weights | Day 5 | 0.7 grams | Standard Deviation 0.276 |
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.
Time frame: once a day for six days and on day 30
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Confirmed Respiratory Infection | Severity of Symptom Score - NASAL CONGESTION | Day 30 | 0.4 units on a scale | Standard Deviation 0.089 |
| Confirmed Respiratory Infection | Severity of Symptom Score - NASAL CONGESTION | Day 1 | 1.5 units on a scale | Standard Deviation 0.144 |
| Confirmed Respiratory Infection | Severity of Symptom Score - NASAL CONGESTION | Day 2 | 1.8 units on a scale | Standard Deviation 0.106 |
| Confirmed Respiratory Infection | Severity of Symptom Score - NASAL CONGESTION | Day 3 | 1.7 units on a scale | Standard Deviation 0.138 |
| Confirmed Respiratory Infection | Severity of Symptom Score - NASAL CONGESTION | Day 4 | 1.4 units on a scale | Standard Deviation 0.118 |
| Confirmed Respiratory Infection | Severity of Symptom Score - NASAL CONGESTION | Day 5 | 1.3 units on a scale | Standard Deviation 0.113 |
| Confirmed Respiratory Infection | Severity of Symptom Score - NASAL CONGESTION | Day 6 | 1.4 units on a scale | Standard Deviation 0.118 |
| Unconfirmed Respiratory Infection | Severity of Symptom Score - NASAL CONGESTION | Day 30 | 0.4 units on a scale | Standard Deviation 0.104 |
| Unconfirmed Respiratory Infection | Severity of Symptom Score - NASAL CONGESTION | Day 4 | 1.0 units on a scale | Standard Deviation 0.133 |
| Unconfirmed Respiratory Infection | Severity of Symptom Score - NASAL CONGESTION | Day 1 | 1.5 units on a scale | Standard Deviation 0.14 |
| Unconfirmed Respiratory Infection | Severity of Symptom Score - NASAL CONGESTION | Day 6 | 1.1 units on a scale | Standard Deviation 0.136 |
| Unconfirmed Respiratory Infection | Severity of Symptom Score - NASAL CONGESTION | Day 2 | 1.4 units on a scale | Standard Deviation 0.129 |
| Unconfirmed Respiratory Infection | Severity of Symptom Score - NASAL CONGESTION | Day 5 | 1.2 units on a scale | Standard Deviation 0.117 |
| Unconfirmed Respiratory Infection | Severity of Symptom Score - NASAL CONGESTION | Day 3 | 1.2 units on a scale | Standard Deviation 0.139 |
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.
Time frame: once a day for six days and on day 30
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Confirmed Respiratory Infection | Severity of Symptom Scores - COUGH | Day 3 | 1.5 units on a scale | Standard Deviation 0.121 |
| Confirmed Respiratory Infection | Severity of Symptom Scores - COUGH | Day 5 | 1.3 units on a scale | Standard Deviation 0.071 |
| Confirmed Respiratory Infection | Severity of Symptom Scores - COUGH | Day 2 | 1.6 units on a scale | Standard Deviation 0.089 |
| Confirmed Respiratory Infection | Severity of Symptom Scores - COUGH | Day 6 | 0.7 units on a scale | Standard Deviation 0.082 |
| Confirmed Respiratory Infection | Severity of Symptom Scores - COUGH | Day 4 | 1.3 units on a scale | Standard Deviation 0.113 |
| Confirmed Respiratory Infection | Severity of Symptom Scores - COUGH | Day 30 | 0.2 units on a scale | Standard Deviation 0.071 |
| Confirmed Respiratory Infection | Severity of Symptom Scores - COUGH | Day 1 | 1.5 units on a scale | Standard Deviation 0.121 |
| Unconfirmed Respiratory Infection | Severity of Symptom Scores - COUGH | Day 30 | 0.1 units on a scale | Standard Deviation 0.052 |
| Unconfirmed Respiratory Infection | Severity of Symptom Scores - COUGH | Day 1 | 0.7 units on a scale | Standard Deviation 0.147 |
| Unconfirmed Respiratory Infection | Severity of Symptom Scores - COUGH | Day 2 | 0.7 units on a scale | Standard Deviation 0.145 |
| Unconfirmed Respiratory Infection | Severity of Symptom Scores - COUGH | Day 3 | 0.7 units on a scale | Standard Deviation 0.137 |
| Unconfirmed Respiratory Infection | Severity of Symptom Scores - COUGH | Day 4 | 0.5 units on a scale | Standard Deviation 0.118 |
| Unconfirmed Respiratory Infection | Severity of Symptom Scores - COUGH | Day 5 | 0.4 units on a scale | Standard Deviation 0.102 |
| Unconfirmed Respiratory Infection | Severity of Symptom Scores - COUGH | Day 6 | 0.4 units on a scale | Standard Deviation 0.104 |
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.
Time frame: once a day for six days and on Day 30
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Confirmed Respiratory Infection | Severity of Symptom Score - SNEEZING | Day 30 | 0.4 units on a scale | Standard Deviation 0.089 |
| Confirmed Respiratory Infection | Severity of Symptom Score - SNEEZING | Day 1 | 0.9 units on a scale | Standard Deviation 0.095 |
| Confirmed Respiratory Infection | Severity of Symptom Score - SNEEZING | Day 2 | 0.9 units on a scale | Standard Deviation 0.053 |
| Confirmed Respiratory Infection | Severity of Symptom Score - SNEEZING | Day 3 | 0.7 units on a scale | Standard Deviation 0.113 |
| Confirmed Respiratory Infection | Severity of Symptom Score - SNEEZING | Day 4 | 0.7 units on a scale | Standard Deviation 0.082 |
| Confirmed Respiratory Infection | Severity of Symptom Score - SNEEZING | Day 5 | 0.6 units on a scale | Standard Deviation 0.089 |
| Confirmed Respiratory Infection | Severity of Symptom Score - SNEEZING | Day 6 | 0.5 units on a scale | Standard Deviation 0.092 |
| Unconfirmed Respiratory Infection | Severity of Symptom Score - SNEEZING | Day 30 | 0.2 units on a scale | Standard Deviation 0.093 |
| Unconfirmed Respiratory Infection | Severity of Symptom Score - SNEEZING | Day 4 | 0.7 units on a scale | Standard Deviation 0.145 |
| Unconfirmed Respiratory Infection | Severity of Symptom Score - SNEEZING | Day 1 | 0.9 units on a scale | Standard Deviation 0.179 |
| Unconfirmed Respiratory Infection | Severity of Symptom Score - SNEEZING | Day 6 | 0.5 units on a scale | Standard Deviation 0.14 |
| Unconfirmed Respiratory Infection | Severity of Symptom Score - SNEEZING | Day 2 | 0.8 units on a scale | Standard Deviation 0.179 |
| Unconfirmed Respiratory Infection | Severity of Symptom Score - SNEEZING | Day 5 | 0.6 units on a scale | Standard Deviation 0.117 |
| Unconfirmed Respiratory Infection | Severity of Symptom Score - SNEEZING | Day 3 | 0.7 units on a scale | Standard Deviation 0.145 |