The Role of Epigenetics in Inner City Asthma

NCT01382836 | Completed DMC

• 1 other identifier: DAIT ICAC-15
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

Brief Summary

As part of ongoing efforts to determine the causes of asthma and the progression of the disease, this study will gather data to explore the interaction of genetic and environmental factors in the cause and severity of asthma in inner city children.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Global DNA methylation patterns in PBMCs isolated from the persistent asthmatics and non-atopic healthy controls

  24 months

Secondary Outcomes (3)

• Global DNA methylation patterns in nasal epithelial cells

  24 months

• DNA methylation patterns in PBMCs isolated from the parent(s) and/or siblings

  24 months

• Gene expression profiles of RNA extracted from PBMCs and nasal epithelial cells of the persistent asthmatics and non-atopic healthy controls

  24 months

Study Arms (2)

Black inner city children with persistent asthma

Black inner city non-atopic healthy children

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Black inner city children with:1.)persistent asthma and 2.) without asthma.

You may qualify if:

• Black inner city children with or without asthma.
• Control Subjects:
• Black males and females ages 6 to 12 years, inclusive, at Recruitment;
• Who do not have a diagnosis of asthma by a physician;
• Who do not have a diagnosis of atopic dermatitis by a physician;
• Who have an FEV1 ≥ 85% predicted;
• With no positive prick skin-tests to any of a panel of indoor and outdoor allergens;
• With no current asthma as determined by the Respiratory Health Questionnaire (RHQ);
• With no current chronic rhinitis/sinusitis as determined by the RHQ;
• Whose primary place of residence is in one of the pre-selected recruitment census tracts that contains at least 15% of households below the U.S. government poverty level;
• Who are able to perform spirometry (according to the Epigenetics Manual of Operations criteria);
• Whose parent or legal guardian is willing to sign the written Informed Consent prior to initiation of any study procedure;
• Who are willing to sign the assent form, if age appropriate.
• Asthmatic Participants:
• Black males and females ages 6 to 12 years, inclusive, at Recruitment;

You may not qualify if:

• Who have a sibling already enrolled in the study (i.e. one individual from each family is permitted to participate \[case or control\], though samples will be collected from parents and siblings);
• Who have received systemic prednisone (or equivalent) during the 30 days prior to the screening visit;
• Who have received systemic prednisone (or equivalent) for \> 15 days out of the past 60 days prior to the screening visit;
• Who are pregnant or lactating;
• With acute sinusitis, chest infection, or ear infection that required treatment with antibiotics within 30 days of the screening visit;
• Who are currently participating in another asthma-related pharmaceutical study or intervention study or who have participated in another asthma-related pharmaceutical study or intervention study in the month prior to the screening visit;
• Who are currently receiving or have received hyposensitization therapy to any allergen in the past year prior to the screening visit;
• Who have the presence of the following chronic medical conditions: cardiac condition requiring daily medication, seizure disorder requiring daily medication, obvious severe mental retardation that prohibits the subject from answering questions or following instructions, cystic fibrosis, immune deficiency, diabetes, allergic bronchopulmonary aspergillosis, or any other chronic medical condition at the discretion of the study physician. (Exceptions: Attention deficit disorder with or without hyperactivity; iron deficiency anemia; gastroesophageal reflux disease; otitis media (ear infections); sinusitis; allergic rhinitis);
• Who do not speak and understand English;
• Whose caretaker does not speak and understand English.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (6)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Yang IV, Pedersen BS, Liu A, O'Connor GT, Teach SJ, Kattan M, Misiak RT, Gruchalla R, Steinbach SF, Szefler SJ, Gill MA, Calatroni A, David G, Hennessy CE, Davidson EJ, Zhang W, Gergen P, Togias A, Busse WW, Schwartz DA. DNA methylation and childhood asthma in the inner city. J Allergy Clin Immunol. 2015 Jul;136(1):69-80. doi: 10.1016/j.jaci.2015.01.025. Epub 2015 Mar 11.

  PMID: 25769910 RESULT

Related Links

• NIAID Programs on Asthma in the Inner City

Biospecimen

Retention: SAMPLES WITH DNA

DNA, RNA, serum, and plasma specimens

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• David Schwartz, MD

  National Jewish Health

  STUDY CHAIR

• Andrew Liu, MD

  National Jewish Health

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 27, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 6, 2015

Record last verified: 2015-11

Locations

US (6)