Treatment of Persistent Wheezing in Infants and Children
Primary Purpose
Asthma, Respiratory Sounds
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inhaled Fluticasone
Sponsored by
About this trial
This is an interventional diagnostic trial for Asthma focused on measuring Wheezing
Eligibility Criteria
Inclusion Criteria: Moderate to severe persistent wheezing, as defined by the National Asthma Education and Prevention Program Expert Panel Report 2 No signs of upper or lower respiratory tract infection for at least two weeks prior to study entry Exclusion Criteria: Received therapy with inhaled corticosteroids in the month prior to study entry History of seizures or other neurologic disorders Hypoxemia requiring supplemental oxygen to maintain oxygen saturation above 90% Sepsis Underwent a tracheostomy Heart disease Suspected or documented pulmonary hypertension Currently undergoing assisted ventilation Born at less than 36 weeks gestation
Sites / Locations
- University of Michigan
Outcomes
Primary Outcome Measures
Change in FEF75 levels
Change in RV/TLC ratio
Loss of bronchodilator responsiveness (measured at the end of the one month treatment period and follow-up evaluation when participant is 5 years of age)
Secondary Outcome Measures
Change in asthma symptom scores (measured at the end of the one month treatment period and follow-up evaluation when participant is 5 years of age)
Full Information
NCT ID
NCT00301171
First Posted
March 9, 2006
Last Updated
July 28, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00301171
Brief Title
Treatment of Persistent Wheezing in Infants and Children
Official Title
Respiratory Function in Infants With Persistent Wheezing
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
Wheezing is a high-pitched whistling sound that is produced when air flows through narrowed lung airways. It is a common symptom of asthma. Persistent wheezing is commonly treated with bronchodilators and inhaled steroids; however, when wheezing is temporarily caused by a virus or exposure to tobacco smoke, this may not be the most effective treatment. The purpose of this study is to evaluate the cause of wheezing in infants and children and to assess the effectiveness of inhaled steroids on improving lung function.
Detailed Description
Asthma prevalence has steadily increased in the United States since the early 1980s, with infants and young children showing the largest increase. Some young children experience wheezing, but it is not known if this is related specifically to asthma. Wheezing may be caused by a respiratory syncytial virus, maternal smoking, a family history of asthma, or allergies. In addition, some infants who experience wheezing may have small or dysfunctional airways and may not respond well to commonly prescribed anti-inflammatory medications. Because of the many causes of wheezing, in order to prescribe the most effective treatment, it is necessary to thoroughly assess lung function, allergic sensitization, and airway inflammation. The purpose of this study is to examine the causes of moderate to severe wheezing in infants and assess the infants' response to inhaled corticosteroid therapy. The study will also assess new and safer ways to measure lung function and airway inflammation.
This study will enroll infants with moderate to severe persistent wheezing. At study entry, participants will undergo lung function testing, which will include a spirometry test, measures of lung volumes, and assessment of bronchodilator responsiveness. Exhaled breath condensate and blood will be collected, and skin-prick testing will be performed to test for allergies. Participants will then be randomly assigned to receive either fluticasone, an inhaled steroid, or placebo for one month. At the end of the month, lung function testing will be performed and exhaled breath and serum measures will be collected to assess airway inflammation. Participants will attend a follow-up evaluation at age 5 years. During the evaluation, lung function, exhaled breath condensate, and serum markers of inflammation will be measured again, and skin-prick testing will also be performed again.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Respiratory Sounds
Keywords
Wheezing
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Inhaled Fluticasone
Primary Outcome Measure Information:
Title
Change in FEF75 levels
Title
Change in RV/TLC ratio
Title
Loss of bronchodilator responsiveness (measured at the end of the one month treatment period and follow-up evaluation when participant is 5 years of age)
Secondary Outcome Measure Information:
Title
Change in asthma symptom scores (measured at the end of the one month treatment period and follow-up evaluation when participant is 5 years of age)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate to severe persistent wheezing, as defined by the National Asthma Education and Prevention Program Expert Panel Report 2
No signs of upper or lower respiratory tract infection for at least two weeks prior to study entry
Exclusion Criteria:
Received therapy with inhaled corticosteroids in the month prior to study entry
History of seizures or other neurologic disorders
Hypoxemia requiring supplemental oxygen to maintain oxygen saturation above 90%
Sepsis
Underwent a tracheostomy
Heart disease
Suspected or documented pulmonary hypertension
Currently undergoing assisted ventilation
Born at less than 36 weeks gestation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy G. Filbrun, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Persistent Wheezing in Infants and Children
We'll reach out to this number within 24 hrs