- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00459576
Risk of Asthma in Infants With Atopic Dermatitis
April 16, 2013 updated by: Indiana University School of Medicine
Infants will be enrolled in this study if they have never been diagnosed with asthma or wheezing and have been diagnosed with atopic dermatitis or eczema.
Infants with some types of skin rashes are at high risk for developing asthma by 6 years of age.
The purpose of this study is to determine whether we can identify infants who will develop asthma.
Study Overview
Status
Completed
Conditions
Detailed Description
Asthma is a disease characterized by recurrent episodes of wheezing, inflammation of the airways, and airways that are very sensitive to stimulation (hyper-responsiveness).
Symptoms of asthma frequently begin in early childhood; however, it has been difficult to identify pre-symptomatic, at-risk infants and toddlers.
Family history of asthma and allergy is strongly associated with the early onset and persistence of asthma symptoms, and children with early onset persistent asthma are more likely to demonstrate allergies.
The development of allergic disease results from complex interactions between genetic susceptibility and environmental factors; however, infants with atopic dermatitis have a 50% chance of developing asthma by 6 years of age.
Airway inflammation and airway hyper-responsiveness are characteristics of asthmatic children.
We plan to evaluate whether infants with allergic dermatitis have evidence of airway inflammation and hyper-responsiveness, and whether cells from the blood and the nose are also hyper-responsive to stimulation prior to the onset of clinical symptoms of asthma.
In addition we will evaluate whether certain genetic profiles are associated with allergic disease in infants.
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 7 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Our population was recruited through primary physician, pediatric practices, and dermatology groups through out Indianapolis Indiana and the surrounding counties.
We also ran ads in local newspapers.
Description
Inclusion criteria-
- Full term infants born greater than 37 weeks
- History of atopic dermatitis or eczema
Exclusion criteria
- Heart disease
- asthma
- Respiratory illness such as RSV, bronchiolitis or croup
- Hospitalization for respiratory illness
- History of wheezing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Robert S Tepper, MD, PhD, Indiana University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
April 11, 2007
First Submitted That Met QC Criteria
April 11, 2007
First Posted (Estimate)
April 12, 2007
Study Record Updates
Last Update Posted (Estimate)
April 17, 2013
Last Update Submitted That Met QC Criteria
April 16, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Skin Diseases, Eczematous
- Asthma
- Dermatitis
- Eczema
- Dermatitis, Atopic
Other Study ID Numbers
- 0211-15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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