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Trial record 24 of 35 for:    "Bronchial Disease" | "Epinephrine"

Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

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ClinicalTrials.gov Identifier: NCT00435994
Recruitment Status : Completed
First Posted : February 16, 2007
Results First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bronchiolitis
Respiratory Syncytial Virus Infections
Interventions Drug: Inhaled primatene will be given as a breathing treatment
Other: Nasal Washing
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Healthy Control Respiratory Syncytial Virus Bronchiolitis-Nasal Wash Only
Hide Arm/Group Description Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity 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 Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.
Period Title: Overall Study
Started 22 25 12
Completed 15 [1] 25 12
Not Completed 7 0 0
Reason Not Completed
Lost to Follow-up             7             0             0
[1]
7 of the subjects were consented and did not complete the study procedures.
Arm/Group Title Healthy Control Respiratory Syncytial Virus Bronchiolitis Total
Hide Arm/Group Description Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity 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 Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only. Total of all reporting groups
Overall Number of Baseline Participants 22 25 12 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 22 participants 25 participants 12 participants 59 participants
13  (5) 7  (6) 7  (4) 11  (6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 25 participants 12 participants 59 participants
Female
9
  40.9%
7
  28.0%
4
  33.3%
20
  33.9%
Male
13
  59.1%
18
  72.0%
8
  66.7%
39
  66.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 25 participants 12 participants 59 participants
22 25 12 59
1.Primary Outcome
Title Lung Function
Hide Description 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.
Time Frame Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Healthy Control Respiratory Syncytial Virus
Hide Arm/Group Description:
Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity had spirometry performed under sedation.
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
Overall Number of Participants Analyzed 10 3
Mean (Standard Deviation)
Unit of Measure: Z score
Baseline 0.071  (0.586) -3.179  (2.610)
Post Bronchodilator 0.186  (0.639) -3.345  (2.112)
Post Epinephrine 0.041  (0.802) -2.430  (2.716)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Control, Respiratory Syncytial Virus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Endothelial Growth Factor (VEGF)
Hide Description Analysis for VEGF level by ELISA
Time Frame During nasal wash
Hide Outcome Measure Data
Hide Analysis Population Description
Due to limited samples and the length of time that has passed since they were obtained, we are unable to separate Bronchiolitis from RSV.
Arm/Group Title Healthy Control Bronchiolitis and Respiratory Syncytial Virus-Nasal Wash Only
Hide Arm/Group Description:
Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
Infants 2 months to 24 months who were diagnosed with bronchiolitis and respiratory syncytial virus received nasal wash only.
Overall Number of Participants Analyzed 19 9
Mean (Standard Deviation)
Unit of Measure: pg/dl
183.526  (223.268) 568.867  (407.257)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Control, Bronchiolitis and Respiratory Syncytial Virus-Nasal Wash Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0020
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Control Respiratory Syncytial Virus Bronchiolitis
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Healthy Control Respiratory Syncytial Virus Bronchiolitis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Control Respiratory Syncytial Virus Bronchiolitis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/25 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Control Respiratory Syncytial Virus Bronchiolitis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/25 (0.00%)   0/12 (0.00%) 
More than half of our infants woke up before completion of the protocol therefore limiting our analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Robert Tepper, MD, Ph.D.
Organization: Indiana University
Phone: 317-274-9647
Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00435994     History of Changes
Other Study ID Numbers: 0311-21
First Submitted: January 25, 2007
First Posted: February 16, 2007
Results First Submitted: November 12, 2015
Results First Posted: June 1, 2016
Last Update Posted: June 1, 2016