- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01382836
The Role of Epigenetics in Inner City Asthma
The Role of Epigenetics in Inner City Asthma (ICAC-15)
Visão geral do estudo
Status
Condições
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Colorado
-
Denver, Colorado, Estados Unidos, 80206
- National Jewish Health
-
-
District of Columbia
-
Washington, District of Columbia, Estados Unidos, 20010
- Children's National Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02118
- Boston University School of Medicine
-
-
Michigan
-
Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Health System
-
-
New York
-
New York, New York, Estados Unidos, 10032
- Columbia University Medical Center
-
-
Texas
-
Dallas, Texas, Estados Unidos, 75390
- University of Texas Southwestern Medical Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
-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;
- 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.
Exclusion Criteria:
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
---|
Black inner city children with persistent asthma
|
Black inner city non-atopic healthy children
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Global DNA methylation patterns in PBMCs isolated from the persistent asthmatics and non-atopic healthy controls
Prazo: 24 months
|
24 months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Global DNA methylation patterns in nasal epithelial cells
Prazo: 24 months
|
24 months
|
DNA methylation patterns in PBMCs isolated from the parent(s) and/or siblings
Prazo: 24 months
|
24 months
|
Gene expression profiles of RNA extracted from PBMCs and nasal epithelial cells of the persistent asthmatics and non-atopic healthy controls
Prazo: 24 months
|
24 months
|
Colaboradores e Investigadores
Investigadores
- Cadeira de estudo: David Schwartz, MD, National Jewish Health
- Cadeira de estudo: Andrew Liu, MD, National Jewish Health
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- DAIT ICAC-15
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .