NCT00301171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

July 29, 2016

Status Verified

December 1, 2007

First QC Date

March 9, 2006

Last Update Submit

July 28, 2016

Conditions

AsthmaRespiratory Sounds

Keywords

Wheezing

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (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)

Interventions

Inhaled FluticasoneDRUG

Eligibility Criteria

AgeUp to 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

AsthmaRespiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amy G. Filbrun, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 9, 2006

First Posted

March 10, 2006

Study Start

September 1, 2003

Study Completion

August 1, 2007

Last Updated

July 29, 2016

Record last verified: 2007-12

Locations

US(1)