Trial Outcomes & Findings for The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years (NCT NCT00405509)
NCT ID: NCT00405509
Last Updated: 2016-08-19
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
33 participants
Primary outcome timeframe
once a day for 6 days and on day 30
Results posted on
2016-08-19
Participant Flow
Subjects were recruited from private practice pediatric and family practice offices. Some subjects were recruited via Institutional Review Board (IRB)-approved advertisement.
Participant milestones
| Measure |
Confirmed Respiratory Infection
respiratory infection virus type confirmed by assay
|
Unconfirmed Respiratory Infection
participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
22
|
|
Overall Study
COMPLETED
|
11
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years
Baseline characteristics by cohort
| Measure |
Confirmed Respiratory Infection
n=11 Participants
participants who had the type of viral infection confirmed by assay
|
Unconfirmed Respiratory Infection
n=22 Participants
participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
Age
|
9.0 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
9.6 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
9.4 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
22 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: once 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
Outcome measures
| Measure |
Confirmed Respiratory Infection
n=11 Participants
respiratory infection virus type confirmed by assay
|
Unconfirmed Respiratory Infection
n=22 Participants
participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
|
|---|---|---|
|
Local Leukotriene Levels
Day 1
|
440 pg/ml
Standard Deviation 70.34
|
368 pg/ml
Standard Deviation 56.54
|
|
Local Leukotriene Levels
Day 2
|
440 pg/ml
Standard Deviation 48.78
|
619 pg/ml
Standard Deviation 103.21
|
|
Local Leukotriene Levels
Day 3
|
676 pg/ml
Standard Deviation 136.87
|
368 pg/ml
Standard Deviation 75.94
|
|
Local Leukotriene Levels
Day 4
|
992 pg/ml
Standard Deviation 306.84
|
300 pg/ml
Standard Deviation 50.51
|
|
Local Leukotriene Levels
Day 5
|
737 pg/ml
Standard Deviation 310.34
|
530 pg/ml
Standard Deviation 98.35
|
|
Local Leukotriene Levels
Day 6
|
624 pg/ml
Standard Deviation 145.6
|
753 pg/ml
Standard Deviation 185.8
|
|
Local Leukotriene Levels
Day 30
|
479 pg/ml
Standard Deviation 120.55
|
615 pg/ml
Standard Deviation 127.54
|
SECONDARY outcome
Timeframe: each day for 5 daysNasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight
Outcome measures
| Measure |
Confirmed Respiratory Infection
n=11 Participants
respiratory infection virus type confirmed by assay
|
Unconfirmed Respiratory Infection
n=22 Participants
participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
|
|---|---|---|
|
Nasal Secretion Weights
Day 2
|
2.9 grams
Standard Deviation 0.618
|
0.8 grams
Standard Deviation 0.176
|
|
Nasal Secretion Weights
Day 3
|
2.0 grams
Standard Deviation 0.309
|
0.8 grams
Standard Deviation 0.276
|
|
Nasal Secretion Weights
Day 4
|
1.8 grams
Standard Deviation 0.420
|
0.8 grams
Standard Deviation 0.210
|
|
Nasal Secretion Weights
Day 5
|
2.0 grams
Standard Deviation 0.309
|
0.7 grams
Standard Deviation 0.276
|
|
Nasal Secretion Weights
Day 6
|
1.5 grams
Standard Deviation 0.301
|
0.8 grams
Standard Deviation 0.188
|
SECONDARY outcome
Timeframe: once 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.
Outcome measures
| Measure |
Confirmed Respiratory Infection
n=11 Participants
respiratory infection virus type confirmed by assay
|
Unconfirmed Respiratory Infection
n=22 Participants
participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
|
|---|---|---|
|
Severity of Symptom Scores - COUGH
Day 30
|
0.2 units on a scale
Standard Deviation 0.071
|
0.1 units on a scale
Standard Deviation 0.052
|
|
Severity of Symptom Scores - COUGH
Day 1
|
1.5 units on a scale
Standard Deviation 0.121
|
0.7 units on a scale
Standard Deviation 0.147
|
|
Severity of Symptom Scores - COUGH
Day 2
|
1.6 units on a scale
Standard Deviation 0.089
|
0.7 units on a scale
Standard Deviation 0.145
|
|
Severity of Symptom Scores - COUGH
Day 3
|
1.5 units on a scale
Standard Deviation 0.121
|
0.7 units on a scale
Standard Deviation 0.137
|
|
Severity of Symptom Scores - COUGH
Day 4
|
1.3 units on a scale
Standard Deviation 0.113
|
0.5 units on a scale
Standard Deviation 0.118
|
|
Severity of Symptom Scores - COUGH
Day 5
|
1.3 units on a scale
Standard Deviation 0.071
|
0.4 units on a scale
Standard Deviation 0.102
|
|
Severity of Symptom Scores - COUGH
Day 6
|
0.7 units on a scale
Standard Deviation 0.082
|
0.4 units on a scale
Standard Deviation 0.104
|
SECONDARY outcome
Timeframe: once 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.
Outcome measures
| Measure |
Confirmed Respiratory Infection
n=11 Participants
respiratory infection virus type confirmed by assay
|
Unconfirmed Respiratory Infection
n=22 Participants
participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
|
|---|---|---|
|
Severity of Symptom Score - NASAL CONGESTION
Day 1
|
1.5 units on a scale
Standard Deviation 0.144
|
1.5 units on a scale
Standard Deviation 0.14
|
|
Severity of Symptom Score - NASAL CONGESTION
Day 2
|
1.8 units on a scale
Standard Deviation 0.106
|
1.4 units on a scale
Standard Deviation 0.129
|
|
Severity of Symptom Score - NASAL CONGESTION
Day 3
|
1.7 units on a scale
Standard Deviation 0.138
|
1.2 units on a scale
Standard Deviation 0.139
|
|
Severity of Symptom Score - NASAL CONGESTION
Day 4
|
1.4 units on a scale
Standard Deviation 0.118
|
1.0 units on a scale
Standard Deviation 0.133
|
|
Severity of Symptom Score - NASAL CONGESTION
Day 5
|
1.3 units on a scale
Standard Deviation 0.113
|
1.2 units on a scale
Standard Deviation 0.117
|
|
Severity of Symptom Score - NASAL CONGESTION
Day 6
|
1.4 units on a scale
Standard Deviation 0.118
|
1.1 units on a scale
Standard Deviation 0.136
|
|
Severity of Symptom Score - NASAL CONGESTION
Day 30
|
0.4 units on a scale
Standard Deviation 0.089
|
0.4 units on a scale
Standard Deviation 0.104
|
SECONDARY outcome
Timeframe: once 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.
Outcome measures
| Measure |
Confirmed Respiratory Infection
n=11 Participants
respiratory infection virus type confirmed by assay
|
Unconfirmed Respiratory Infection
n=22 Participants
participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
|
|---|---|---|
|
Severity of Symptom Score - SNEEZING
Day 6
|
0.5 units on a scale
Standard Deviation 0.092
|
0.5 units on a scale
Standard Deviation 0.14
|
|
Severity of Symptom Score - SNEEZING
Day 1
|
0.9 units on a scale
Standard Deviation 0.095
|
0.9 units on a scale
Standard Deviation 0.179
|
|
Severity of Symptom Score - SNEEZING
Day 2
|
0.9 units on a scale
Standard Deviation 0.053
|
0.8 units on a scale
Standard Deviation 0.179
|
|
Severity of Symptom Score - SNEEZING
Day 3
|
0.7 units on a scale
Standard Deviation 0.113
|
0.7 units on a scale
Standard Deviation 0.145
|
|
Severity of Symptom Score - SNEEZING
Day 4
|
0.7 units on a scale
Standard Deviation 0.082
|
0.7 units on a scale
Standard Deviation 0.145
|
|
Severity of Symptom Score - SNEEZING
Day 5
|
0.6 units on a scale
Standard Deviation 0.089
|
0.6 units on a scale
Standard Deviation 0.117
|
|
Severity of Symptom Score - SNEEZING
Day 30
|
0.4 units on a scale
Standard Deviation 0.089
|
0.2 units on a scale
Standard Deviation 0.093
|
Adverse Events
Confirmed Respiratory Virus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unconfirmed Respiratory Infection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place