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Treatment of Persistent Wheezing in Infants and Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00301171
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : July 29, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

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.

Condition or disease Intervention/treatment Phase
Asthma Respiratory Sounds Drug: Inhaled Fluticasone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Respiratory Function in Infants With Persistent Wheezing
Study Start Date : September 2003
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Fluticasone

Primary Outcome Measures :
  1. Change in FEF75 levels
  2. Change in RV/TLC ratio
  3. 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 :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00301171

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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Amy G. Filbrun, MD University of Michigan

Layout table for additonal information Identifier: NCT00301171     History of Changes
Other Study ID Numbers: 370
K23HL067881-04 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: December 2007
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Additional relevant MeSH terms:
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Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents