The Genetics of Severe Asthma in Children
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ClinicalTrials.gov Identifier: NCT01238432 |
Recruitment Status :
Active, not recruiting
First Posted : November 10, 2010
Last Update Posted : July 12, 2021
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Condition or disease |
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Asthma |

Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | The Genetics of Severe Asthma in Children |
Study Start Date : | October 2009 |
Estimated Primary Completion Date : | April 2025 |
Estimated Study Completion Date : | April 2025 |
Group/Cohort |
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Inpatient population
Children with asthma who are admitted to the hospital with an exacerbation.
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Outpatient population
Children with asthma who have not been admitted to the hospital with an exacerbation.
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Healthy controls
Children without asthma or any other chronic condition.
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- The primary end point is the development of a near fatal asthma exacerbation. [ Time Frame: 3 years ]
- The secondary end point is hospital length of stay. [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 4 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria, inpatient asthmatics:
- Admission to study institution with a primary admission diagnosis of asthma exacerbation
- Age between 4 and 18 years
Exclusion Criteria, inpatient asthmatics:
- Pre-existing chronic disease (other than asthma), including: i. bronchopulmonary dysplasia ii. bronchomalacia iii. tracheomalacia iv. laryngomalacia v. vocal cord dysfunction vi. chronic restrictive lung disease vii. recurrent aspiration pneumonia viii. impaired mucous clearance ix. congenital heart disease x. pulmonary hypertension
Inclusion Criteria, outpatient asthmatics:
- Diagnosis of asthma
- Age between 4 and 18 years
Exclusion Criteria, outpatient asthmatics:
- Previous admission to the hospital for a near fatal asthma exacerbation
- Pre-existing chronic disease (other than asthma) including i. bronchopulmonary dysplasia ii. bronchomalacia iii. tracheomalacia iv. laryngomalacia v. vocal cord dysfunction vi. chronic restrictive lung disease vii. recurrent aspiration pneumonia viii. impaired mucous clearance ix. congenital heart disease x. pulmonary hypertension
Inclusion Criteria, healthy controls:
- Age between 4 and 18 years
Exclusion Criteria, healthy controls:
- Pre-existing chronic disease including: i. asthma ii. bronchopulmonary dysplasia iii. bronchomalacia iv. tracheomalacia v. laryngomalacia vi. vocal cord dysfunction vii. chronic restrictive lung disease viii. recurrent aspiration pneumonia ix. impaired mucous clearance x. congenital heart disease xi. pulmonary hypertension

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 ClinicalTrials.gov identifier (NCT number): NCT01238432
United States, Connecticut | |
Connecticut Children's Medical Center | |
Hartford, Connecticut, United States, 06103 |
Principal Investigator: | Christopher L Carroll, MD, MS | Connecticut Children's Medical Center |
Responsible Party: | Christopher Carroll, MD, Associate Professor of Pediatrics, Connecticut Children's Medical Center |
ClinicalTrials.gov Identifier: | NCT01238432 |
Other Study ID Numbers: |
08-103 |
First Posted: | November 10, 2010 Key Record Dates |
Last Update Posted: | July 12, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pediatric Polymorphism, Genetic Adrenergic beta-Agonists |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |