AsthmaNCT01382836
The Role of Epigenetics in Inner City Asthma
An observational study of Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 200 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2011to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Black inner city children with:1.)persistent asthma and 2.) without asthma.
Who may be able to join
- -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;
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- 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;
- Who have a diagnosis of asthma by a physician;
- 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);
- 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:
- Asthma symptoms 3 or more days per week during the last two weeks;
- Sleep disturbed due to asthma at least 3 times in the past month;
- 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.
- Evidence of uncontrolled disease as defined by at least one of the following criteria:
- Two or more asthma-related unscheduled visits to an emergency department (ED), urgent care (UC), or clinic in the previous 6 months;
- One or more asthma-related overnight hospitalizations in the previous 6 months.
- With physiologic evidence of reversible airflow obstruction or airway hyperresponsiveness:
- FEV1 < 85% predicted or FEV1/FVC ratio < 0.85 with a bronchodilator response ≥ 10% FEV1;
- Positive methacholine challenge (PC20 < 8 mg/ml) for those individuals who have either:
- Normal airflow (FEV1 ≥ 85% predicted and FEV1/FVC ratio ≥ 0.85);
- Airflow obstruction with a bronchodilator response < 10% FEV1.
- 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);
- 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;
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Boston University School of Medicine
Boston, Massachusetts, 02118
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
Henry Ford Health System
Detroit, Michigan, 48202
Columbia University Medical Center
New York, New York, 10032
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: The Role of Epigenetics in Inner City Asthma (ICAC-15)
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.
Read the detailed description
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.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Black inner city children with persistent asthma | Not described | |
| Black inner city non-atopic healthy children | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global DNA methylation patterns in PBMCs isolated from the persistent asthmatics and non-atopic healthy controls
Measured: 24 months
Secondary outcomes (3)
Global DNA methylation patterns in nasal epithelial cells
Measured: 24 months
DNA methylation patterns in PBMCs isolated from the parent(s) and/or siblings
Measured: 24 months
Gene expression profiles of RNA extracted from PBMCs and nasal epithelial cells of the persistent asthmatics and non-atopic healthy controls
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David Schwartz, MD, Study chair, National Jewish HealthAndrew Liu, MD, Study chair, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382836
- Sponsor's protocol ID
- DAIT ICAC-15
- Status last verified
- Nov 2015
- First submitted
- 24 Jun 2011
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25769910
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Epigenetics in Inner City Asthma (ICAC-15)
- ClinicalTrials.gov ID
- NCT01382836
- Acronym / sponsor ID
- DAIT ICAC-15
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Black inner city children with persistent asthma | – | – |
| Black inner city non-atopic healthy children | – | – |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Black inner city children with:1.)persistent asthma and 2.) without asthma.
Key inclusion criteria (34 listed)
- -Black inner city children with or without asthma.
- -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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Global DNA methylation patterns in PBMCs isolated from the persistent asthmatics and non-atopic healthy controls
Time frame: 24 months
3 secondary outcomes
Global DNA methylation patterns in nasal epithelial cells
Time frame: 24 months
DNA methylation patterns in PBMCs isolated from the parent(s) and/or siblings
Time frame: 24 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
- Results publication: PubMed 25769910Yang 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.
- NIAID Programs on Asthma in the Inner CityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Schwartz, MD study chair
National Jewish Health
Andrew Liu, MD study chair
National Jewish Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global DNA methylation patterns in PBMCs isolated from the persistent asthmatics and non-atopic healthy controls (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01382836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2015.