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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00405509
Enrollment
33
Registered
2006-11-30
Start date
2006-10-31
Completion date
2009-01-31
Last updated
2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Cold, Upper Respiratory Infection

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

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
CollaboratorOTHER
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
West Penn Allegheny Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Local Leukotriene Levelsonce a day for 6 days and on day 30nasal 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

MeasureTime frameDescription
Severity of Symptom Score - SNEEZINGonce a day for six days and on Day 30Sneezing 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 CONGESTIONonce a day for six days and on day 30nasal 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 Weightseach day for 5 daysNasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight
Severity of Symptom Scores - COUGHonce a day for six days and on day 30Cough 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

ArmCount
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
Total33

Baseline characteristics

CharacteristicTotalConfirmed Respiratory InfectionUnconfirmed Respiratory Infection
Age, Categorical
<=18 years
33 Participants11 Participants22 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 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 participants11 participants22 participants
Sex: Female, Male
Female
19 Participants4 Participants15 Participants
Sex: Female, Male
Male
14 Participants7 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 110 / 22
serious
Total, serious adverse events
0 / 110 / 22

Outcome results

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

Time frame: once a day for 6 days and on day 30

ArmMeasureGroupValue (MEAN)Dispersion
Confirmed Respiratory InfectionLocal Leukotriene LevelsDay 3676 pg/mlStandard Deviation 136.87
Confirmed Respiratory InfectionLocal Leukotriene LevelsDay 5737 pg/mlStandard Deviation 310.34
Confirmed Respiratory InfectionLocal Leukotriene LevelsDay 2440 pg/mlStandard Deviation 48.78
Confirmed Respiratory InfectionLocal Leukotriene LevelsDay 6624 pg/mlStandard Deviation 145.6
Confirmed Respiratory InfectionLocal Leukotriene LevelsDay 4992 pg/mlStandard Deviation 306.84
Confirmed Respiratory InfectionLocal Leukotriene LevelsDay 30479 pg/mlStandard Deviation 120.55
Confirmed Respiratory InfectionLocal Leukotriene LevelsDay 1440 pg/mlStandard Deviation 70.34
Unconfirmed Respiratory InfectionLocal Leukotriene LevelsDay 30615 pg/mlStandard Deviation 127.54
Unconfirmed Respiratory InfectionLocal Leukotriene LevelsDay 1368 pg/mlStandard Deviation 56.54
Unconfirmed Respiratory InfectionLocal Leukotriene LevelsDay 2619 pg/mlStandard Deviation 103.21
Unconfirmed Respiratory InfectionLocal Leukotriene LevelsDay 3368 pg/mlStandard Deviation 75.94
Unconfirmed Respiratory InfectionLocal Leukotriene LevelsDay 4300 pg/mlStandard Deviation 50.51
Unconfirmed Respiratory InfectionLocal Leukotriene LevelsDay 5530 pg/mlStandard Deviation 98.35
Unconfirmed Respiratory InfectionLocal Leukotriene LevelsDay 6753 pg/mlStandard Deviation 185.8
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Confirmed Respiratory InfectionNasal Secretion WeightsDay 32.0 gramsStandard Deviation 0.309
Confirmed Respiratory InfectionNasal Secretion WeightsDay 52.0 gramsStandard Deviation 0.309
Confirmed Respiratory InfectionNasal Secretion WeightsDay 41.8 gramsStandard Deviation 0.42
Confirmed Respiratory InfectionNasal Secretion WeightsDay 61.5 gramsStandard Deviation 0.301
Confirmed Respiratory InfectionNasal Secretion WeightsDay 22.9 gramsStandard Deviation 0.618
Unconfirmed Respiratory InfectionNasal Secretion WeightsDay 60.8 gramsStandard Deviation 0.188
Unconfirmed Respiratory InfectionNasal Secretion WeightsDay 20.8 gramsStandard Deviation 0.176
Unconfirmed Respiratory InfectionNasal Secretion WeightsDay 30.8 gramsStandard Deviation 0.276
Unconfirmed Respiratory InfectionNasal Secretion WeightsDay 40.8 gramsStandard Deviation 0.21
Unconfirmed Respiratory InfectionNasal Secretion WeightsDay 50.7 gramsStandard Deviation 0.276
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.

Time frame: once a day for six days and on day 30

ArmMeasureGroupValue (MEAN)Dispersion
Confirmed Respiratory InfectionSeverity of Symptom Score - NASAL CONGESTIONDay 300.4 units on a scaleStandard Deviation 0.089
Confirmed Respiratory InfectionSeverity of Symptom Score - NASAL CONGESTIONDay 11.5 units on a scaleStandard Deviation 0.144
Confirmed Respiratory InfectionSeverity of Symptom Score - NASAL CONGESTIONDay 21.8 units on a scaleStandard Deviation 0.106
Confirmed Respiratory InfectionSeverity of Symptom Score - NASAL CONGESTIONDay 31.7 units on a scaleStandard Deviation 0.138
Confirmed Respiratory InfectionSeverity of Symptom Score - NASAL CONGESTIONDay 41.4 units on a scaleStandard Deviation 0.118
Confirmed Respiratory InfectionSeverity of Symptom Score - NASAL CONGESTIONDay 51.3 units on a scaleStandard Deviation 0.113
Confirmed Respiratory InfectionSeverity of Symptom Score - NASAL CONGESTIONDay 61.4 units on a scaleStandard Deviation 0.118
Unconfirmed Respiratory InfectionSeverity of Symptom Score - NASAL CONGESTIONDay 300.4 units on a scaleStandard Deviation 0.104
Unconfirmed Respiratory InfectionSeverity of Symptom Score - NASAL CONGESTIONDay 41.0 units on a scaleStandard Deviation 0.133
Unconfirmed Respiratory InfectionSeverity of Symptom Score - NASAL CONGESTIONDay 11.5 units on a scaleStandard Deviation 0.14
Unconfirmed Respiratory InfectionSeverity of Symptom Score - NASAL CONGESTIONDay 61.1 units on a scaleStandard Deviation 0.136
Unconfirmed Respiratory InfectionSeverity of Symptom Score - NASAL CONGESTIONDay 21.4 units on a scaleStandard Deviation 0.129
Unconfirmed Respiratory InfectionSeverity of Symptom Score - NASAL CONGESTIONDay 51.2 units on a scaleStandard Deviation 0.117
Unconfirmed Respiratory InfectionSeverity of Symptom Score - NASAL CONGESTIONDay 31.2 units on a scaleStandard Deviation 0.139
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.

Time frame: once a day for six days and on day 30

ArmMeasureGroupValue (MEAN)Dispersion
Confirmed Respiratory InfectionSeverity of Symptom Scores - COUGHDay 31.5 units on a scaleStandard Deviation 0.121
Confirmed Respiratory InfectionSeverity of Symptom Scores - COUGHDay 51.3 units on a scaleStandard Deviation 0.071
Confirmed Respiratory InfectionSeverity of Symptom Scores - COUGHDay 21.6 units on a scaleStandard Deviation 0.089
Confirmed Respiratory InfectionSeverity of Symptom Scores - COUGHDay 60.7 units on a scaleStandard Deviation 0.082
Confirmed Respiratory InfectionSeverity of Symptom Scores - COUGHDay 41.3 units on a scaleStandard Deviation 0.113
Confirmed Respiratory InfectionSeverity of Symptom Scores - COUGHDay 300.2 units on a scaleStandard Deviation 0.071
Confirmed Respiratory InfectionSeverity of Symptom Scores - COUGHDay 11.5 units on a scaleStandard Deviation 0.121
Unconfirmed Respiratory InfectionSeverity of Symptom Scores - COUGHDay 300.1 units on a scaleStandard Deviation 0.052
Unconfirmed Respiratory InfectionSeverity of Symptom Scores - COUGHDay 10.7 units on a scaleStandard Deviation 0.147
Unconfirmed Respiratory InfectionSeverity of Symptom Scores - COUGHDay 20.7 units on a scaleStandard Deviation 0.145
Unconfirmed Respiratory InfectionSeverity of Symptom Scores - COUGHDay 30.7 units on a scaleStandard Deviation 0.137
Unconfirmed Respiratory InfectionSeverity of Symptom Scores - COUGHDay 40.5 units on a scaleStandard Deviation 0.118
Unconfirmed Respiratory InfectionSeverity of Symptom Scores - COUGHDay 50.4 units on a scaleStandard Deviation 0.102
Unconfirmed Respiratory InfectionSeverity of Symptom Scores - COUGHDay 60.4 units on a scaleStandard Deviation 0.104
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.

Time frame: once a day for six days and on Day 30

ArmMeasureGroupValue (MEAN)Dispersion
Confirmed Respiratory InfectionSeverity of Symptom Score - SNEEZINGDay 300.4 units on a scaleStandard Deviation 0.089
Confirmed Respiratory InfectionSeverity of Symptom Score - SNEEZINGDay 10.9 units on a scaleStandard Deviation 0.095
Confirmed Respiratory InfectionSeverity of Symptom Score - SNEEZINGDay 20.9 units on a scaleStandard Deviation 0.053
Confirmed Respiratory InfectionSeverity of Symptom Score - SNEEZINGDay 30.7 units on a scaleStandard Deviation 0.113
Confirmed Respiratory InfectionSeverity of Symptom Score - SNEEZINGDay 40.7 units on a scaleStandard Deviation 0.082
Confirmed Respiratory InfectionSeverity of Symptom Score - SNEEZINGDay 50.6 units on a scaleStandard Deviation 0.089
Confirmed Respiratory InfectionSeverity of Symptom Score - SNEEZINGDay 60.5 units on a scaleStandard Deviation 0.092
Unconfirmed Respiratory InfectionSeverity of Symptom Score - SNEEZINGDay 300.2 units on a scaleStandard Deviation 0.093
Unconfirmed Respiratory InfectionSeverity of Symptom Score - SNEEZINGDay 40.7 units on a scaleStandard Deviation 0.145
Unconfirmed Respiratory InfectionSeverity of Symptom Score - SNEEZINGDay 10.9 units on a scaleStandard Deviation 0.179
Unconfirmed Respiratory InfectionSeverity of Symptom Score - SNEEZINGDay 60.5 units on a scaleStandard Deviation 0.14
Unconfirmed Respiratory InfectionSeverity of Symptom Score - SNEEZINGDay 20.8 units on a scaleStandard Deviation 0.179
Unconfirmed Respiratory InfectionSeverity of Symptom Score - SNEEZINGDay 50.6 units on a scaleStandard Deviation 0.117
Unconfirmed Respiratory InfectionSeverity of Symptom Score - SNEEZINGDay 30.7 units on a scaleStandard Deviation 0.145

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026