The Role of Epigenetics in Inner City Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01382836
First received: June 24, 2011
Last updated: February 25, 2014
Last verified: August 2011
  Purpose

Asthma is a complex, heritable disease that affects more than 11.2% of the U.S. population, which represents approximately 9 million children and 23 million adults. It is thought that asthma may be caused by the interaction of multiple genetic factors, such as whether a parent or sibling has asthma, and environmental factors, such as living in an inner city. Studying DNA from people who have asthma and those who do not have asthma may help us better understand the importance of those genes and how they are involved in asthma severity and response to treatment. 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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Role of Epigenetics in Inner City Asthma (ICAC-15)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Global DNA methylation patterns in PBMCs isolated from the persistent asthmatics and non-atopic healthy controls [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global DNA methylation patterns in nasal epithelial cells [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • DNA methylation patterns in PBMCs isolated from the parent(s) and/or siblings [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Gene expression profiles of RNA extracted from PBMCs and nasal epithelial cells of the persistent asthmatics and non-atopic healthy controls [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA, RNA, serum, and plasma specimens


Enrollment: 200
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Black inner city children with persistent asthma
Black inner city non-atopic healthy children

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Black inner city children with persistent asthma and without asthma

Criteria

Inclusion Criteria:

Black inner city children with or without asthma

Control Participants

  • 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
  • With no current chronic rhinitis/sinusitis as determined by the Respiratory Health Questionnaire
  • 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

  1. Black males and females ages 6 to 12 years, inclusive, at Recruitment.
  2. Who have a diagnosis of asthma by a physician
  3. Who are currently receiving long-term asthma control therapy and either have symptoms consistent with persistent asthma (criterion 3a) or have evidence of uncontrolled disease (criterion 3b); or who are not currently receiving long-term asthma control therapy and have symptoms consistent with persistent asthma (criterion 3a) and have evidence of uncontrolled disease (criterion 3b).

    1. Evidence of persistent asthma as defined by the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (NHLBI 2007), which includes at least one of the following criteria:

      • i. Asthma symptoms 3 or more days per week during the last two weeks.
      • ii. Sleep disturbed due to asthma at least 3 times in the past month.
      • iii. Albuterol use (Metered Dose Inhaler or nebulizer) for quick relief at least 8 times in the past two weeks, not including use as a preventive for exercise.
    2. Evidence of uncontrolled disease as defined by at least one of the following criteria:

      • i. Two or more asthma-related unscheduled visits to an emergency department (ED), urgent care (UC), or clinic in the previous 6 months
      • ii.One or more asthma-related overnight hospitalizations in the previous 6 months.
  4. With physiologic evidence of reversible airflow obstruction or airway hyperresponsiveness:

    1. FEV1 < 85% predicted or FEV1/FVC ratio < 0.85 with a bronchodilator response ≥ 10% FEV1
    2. Positive methacholine challenge (PC20 < 8 mg/ml) for those individuals who have either:

      • i. Normal airflow (FEV1 ≥ 85% predicted and FEV1/FVC ratio ≥ 0.85)
      • ii. Airflow obstruction with a bronchodilator response < 10% FEV1
  5. With a positive prick skin-test to at least one of the panel of indoor aeroallergens (i.e. dust mite, cockroach, mold, cat, dog, rat, mouse)
  6. 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
  7. Who are able to perform spirometry
  8. Whose parent or legal guardian is willing to sign the written Informed Consent prior to initiation of any study procedure.
  9. Who are willing to sign the assent form, if age appropriate.

Exclusion Criteria:

  1. 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)
  2. Who have received systemic prednisone (or equivalent) during the 30 days prior to the screening visit.
  3. Who have received systemic prednisone (or equivalent) for > 15 days out of the past 60 days prior to the screening visit.
  4. Who are pregnant or lactating
  5. With acute sinusitis, chest infection, or ear infection that required treatment with antibiotics within 30 days of the screening visit.
  6. 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
  7. Who are currently receiving or have received hyposensitization therapy to any allergen in the past year prior to the screening visit
  8. 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.)
  9. Who do not speak and understand English
  10. Whose caretaker does not speak and understand English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382836

Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Investigators
Study Chair: David Schwartz, MD National Jewish Health
Study Chair: Andrew Liu, MD National Jewish Health
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01382836     History of Changes
Other Study ID Numbers: DAIT ICAC-15
Study First Received: June 24, 2011
Last Updated: February 25, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014