Trial Outcomes & Findings for Assessment of Airway Obstruction in Infants With Lower Respiratory Infections (NCT NCT00435994)

Results Overview

Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

59 participants

Primary outcome timeframe

Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)

Results posted on

2016-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Control Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity	Respiratory Syncytial Virus Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI	Bronchiolitis-Nasal Wash Only Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.
Overall Study STARTED	22	25	12
Overall Study COMPLETED	15	25	12
Overall Study NOT COMPLETED	7	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Control Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity	Respiratory Syncytial Virus Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI	Bronchiolitis-Nasal Wash Only Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.
Overall Study Lost to Follow-up	7	0	0

Baseline Characteristics

Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Control n=22 Participants Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity	Respiratory Syncytial Virus n=25 Participants Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI	Bronchiolitis n=12 Participants Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.	Total n=59 Participants Total of all reporting groups
Age, Continuous	13 months STANDARD_DEVIATION 5 • n=5 Participants	7 months STANDARD_DEVIATION 6 • n=7 Participants	7 months STANDARD_DEVIATION 4 • n=5 Participants	11 months STANDARD_DEVIATION 6 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	18 Participants n=7 Participants	8 Participants n=5 Participants	39 Participants n=4 Participants
Region of Enrollment United States	22 participants n=5 Participants	25 participants n=7 Participants	12 participants n=5 Participants	59 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)

Population: All participants who had baseline, post bronchodilator and post epinephrine measurements were included. Participants in the Bronchiolitis arm did not have infant pulmonary functions obtained.

Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function.

Outcome measures

Outcome measures
Measure	Healthy Control n=10 Participants Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity had spirometry performed under sedation.	Respiratory Syncytial Virus n=3 Participants Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
Lung Function Baseline	0.071 Z score Standard Deviation 0.586	-3.179 Z score Standard Deviation 2.610
Lung Function Post Bronchodilator	0.186 Z score Standard Deviation 0.639	-3.345 Z score Standard Deviation 2.112
Lung Function Post Epinephrine	0.041 Z score Standard Deviation 0.802	-2.430 Z score Standard Deviation 2.716

PRIMARY outcome

Timeframe: During nasal wash

Population: Due to limited samples and the length of time that has passed since they were obtained, we are unable to separate Bronchiolitis from RSV.

Analysis for VEGF level by ELISA

Outcome measures

Outcome measures
Measure	Healthy Control n=19 Participants Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity had spirometry performed under sedation.	Respiratory Syncytial Virus n=9 Participants Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
Endothelial Growth Factor (VEGF)	183.526 pg/dl Standard Deviation 223.268	568.867 pg/dl Standard Deviation 407.257

Adverse Events

Healthy Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Respiratory Syncytial Virus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bronchiolitis

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

Robert Tepper, MD, Ph.D.

Indiana University

Phone: 317-274-9647

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place