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Exhaled Breath Condensate as a Measurement of Airway Inflammation in Children With Asthma

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Qué se está recopilando

Colección de datos

Quiénes están siendo reclutados

Enfermedades bronquiales+8

+ Asma

+ Hipersensibilidad

De 5 a 17 años
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Cómo está diseñado el estudio

Observacional
Inicio del estudio: febrero de 2004
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Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 13 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 18 de febrero de 2004

Fecha en la que se inscribió al primer participante.

The onset of asthma is often during childhood, and when the child is atopic, it is more likely to persist into adulthood. Diseases such as asthma have a higher prevalence in childhood; and management that alters the morbidity of allergic disease in children may impact disease outcomes in future years. Asthma is the most prevalent chronic disease in childhood and accounts for the highest rate of hospitalizations in the ages between 0-4 years. Unfortunately, there are few noninvasive objective measurements of pulmonary health in children. Current techniques include determination of peak flow, spirometry, and measurement of nitric oxide (NO). Bronchial inflammation is a central feature of asthma and anti-inflammatory therapy is the mainstay of treatment. Expired NO (eNO) has been shown to correlate with bronchial inflammation. However, the collection of NO has only been available in research settings due to the limitations of collection and analysis. In contrast, exhaled breath condensate (EBC) is easily obtained and pH analysis technically simple. Determination of pH in EBC is a novel, non-invasive technique in clinical study as a means to evaluate the severity of pulmonary inflammation. In the protocol described, we will evaluate the utility of EBC in the measurement of airway disease in 60 children with asthma and compare them to 30 healthy cohorts in the same age range. We will determine if EBC pH is reflective of the degree of morbidity in children by correlating measurements with known parameters of disease including: 1) number of hospitalizations, 2) absenteeism from school, 3) number of asthma exacerbations, 4) loss of work days (if applicable), 5) extent of rescue medication usage, 6) spirometry to evaluate obstruction, and 7) NO as a measurement of inflammation. Subjects will be evaluated and then categorized based on the National Asthma Education and Prevention Program (NAEPP) guidelines. We will measure the pH from EBC in children age 6 to less than 18 years of age and compare findings to clinical data, spirometry, and expired NO. In this way, we will determine if EBC is a potentially useful non-invasive measurement of airway disease. It is hoped that measurements of EBC will be helpful in identifying those children in which the addition of an anti-inflammatory medication is appropriate. We will also attempt to measure inflammatory mediators to determine if they can be used to assess inflammation. This method may also be useful in detecting airway inflammation due to an infectious agent before a systemic reaction (fever, respiratory distress, or cough) is apparent in children with various immunodeficiency diseases such as chronic granulomatous disease (CGD), recurrent respiratory infections without a defined host defect (RIND), or Job's syndrome. We will recruit 30 healthy control children in the same age range to compare the EBC pH values in children without allergic or other chronic pulmonary diseases. In addition, we will recruit 30 children (10 in each group) with CGD, RIND, and Job's to compare exhaled breath condensate pH and exhaled nitric oxide values to those from children with allergic airway inflammation to determine if these methods are useful for early diagnosis of infectious airway inflammation.

Título OficialExhaled Breath Condensate as a Measurement of Airway Inflammation in Children With Asthma 
NCT00078208
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 13 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 128 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 5 a 17 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades bronquialesAsmaHipersensibilidadHipersensibilidad inmediataEnfermedades del sistema inmunitarioInflamaciónEnfermedades del pulmónEnfermedades Pulmonares ObstructivasProcesos PatológicosHipersensibilidad RespiratoriaEnfermedades del Tracto Respiratorio

Criterios

* INCLUSION CRITERIA: ASTHMA: Children ages 5 to less than 18 years at the time he or she is expected to complete the protocol with asthma. One or more of the following criteria will qualify for inclusion: Doctor diagnosed asthma. Chronic cough, worse particularly at night for greater than one month. Recurrent wheezing during the past 6 months. Symptoms of difficulty breathing occurring concurrently or worsened by, exercise, infection, animals, smoke, pollen or strong emotional expression. Medical care for treatment of respiratory symptoms consistent with asthma. Reversible (greater than or equal to 12%) airflow obstruction after an inhaled short-acting beta2-agonist. HEALTHY CONTROL: Children between the ages of 5 and less than 18 years at the time he or she is expected to complete the protocol. Subject (asthma or healthy control) has a non-NIH physician who provides routine and emergency care. When available, permission for access of medical records and pharmacy records will be obtained for subjects with asthma. SUBJECT WITH IMMUNODEFICIENCY: Children between the ages of 5 and less than 18 at the time he or she is expected to complete the protocol. Doctor diagnosed immunodeficiency (CGD, Job's, RIND). EXCLUSION CRITERIA: Unacceptably poor compliance, which in the opinion of the investigator, would interfere with one's ability to study or provide medical care for the subject. Any major illness or condition that, in the opinion of the principal investigator, may interfere with the subject's ability to comply with the conditions of participation in the study: Latex allergy Current tobacco use. URI symptoms in the 4 weeks prior to EBC collection. Any condition that, in the opinion of their primary physician, would affect your child's participation in the study. HIV negative by history. HEALTHY CONTROL: Asthma or allergic rhinitis. Chronic pulmonary disease. URI symptoms in the 4 weeks prior to EBC collection. Chronic corticosteroid therapy (daily or every other day dosing for greater than 14 days). Current tobacco use. HIV negative by history. History of latex allergy. PATIENTS WITH IMMUNODEFICIENCY: Chronic or prophylactic antibiotics. Diagnosis of asthma. Must be off antibiotics for 2 days.

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Suspendido

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesVer ubicación
Completado1 Centros de Estudio