Treatment of Persistent Wheezing in Infants and Children
| Status: | Completed |
|---|---|
| Conditions: | Asthma, Asthma, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/30/2016 |
| Start Date: | September 2003 |
| End Date: | August 2007 |
Respiratory Function in Infants With Persistent Wheezing
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.
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.
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.
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.
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
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