The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome
24 de enero de 2019 actualizado por: Laval University
The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome: A Comparison of Asthma Outcomes in Smoking vs Non-smoking Patients With an Incomplete Reversibility of Airway Obstruction (IRAO)
RATIONALE:
In asthmatic subjects, smoking can lead to several changes in disease characterictics. in smokers of more than 20 pack-years, chronic obstructive pulmonary disease (COPD) can be associated with asthma, also called asthma-COPD overlap syndrome (ACOS). Increasing data support the concept that ACOS is a clinical entity. However, this should be further studied in order to better target therapy.
AIM:
The objective of this study is to evaluate the comparative features of ACOS
METHODS:
This will be a descriptive study comparing the features of the ACOS with the features of asthmatic subjects with an incomplete reversibility of airway obstruction (IRAO).The study will be done over 1 or 2 visits (within a week interval), according to subjects' availability. The visit will include completion of different questionnaires (asthma control asthma quality of life, medical history, exacerbations, etc.), a thoracic examination, allergy skin-prick tests, spirometry and bronchodilator response, lung volumes and compliance measurements, exhaled nitric oxide measurement, blood sampling and a sputum induction.
Descripción general del estudio
Tipo de estudio
De observación
Inscripción (Actual)
115
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Quebec, Canadá, G1V 4G5
- Institut Universitaire de cardiologie et de pneumologie de Quebec
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
45 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Asthmatic subjects will be recruited from the asthma outpatient clinic, from participation to past research studies, or from advertisements.
Descripción
Inclusion Criteria:
ALL SUBJECTS
- Subjects aged 45 years and older.
- Free of any other respiratory condition, except for asthma and/or COPD, which may interfere with the tests.
- Asthma that requires a baseline treatment with inhaled corticosteroids and/or additional asthma medication.
- Free of respiratory infection in the 4 weeks preceding the study.
- No changes in the asthma and COPD-related medications in the 4 weeks preceding the study.
- If female, not pregnant (or lactating).
- Able to adhere to study procedures.
- Able and willing to provide written informed consent to participate in the study, in accordance with international conference on harmonization (ICH) good clinical practice (GCP) requirements.
ACOS SUBJECTS
1. Smokers or ex-smokers of at least 20 pack-years. 2. With an IRAO (see definitions section). IRAO SUBJECTS
- Long-life non-smokers or ex-smokers defined as someone who smoked less than 5 pack-years and who completely stopped smoking for at least 12 months before inclusion in the study.
- With an IRAO.
Exclusion Criteria:
ALL SUBJECTS
- With COPD without a past diagnosis of asthma.
- Unstable respiratory or non-respiratory condition.
- Any active chronic inflammatory disease.
- Any evidence of malignancy (active and/or treated) within the previous 5 years.
- Any significant concomitant illness or injury that would interfere with the subject's participation in the study.
- Any history of bronchial thermoplasty. IRAO SUBJECTS
- Use of any nicotine containing product within 1 year prior to study entry or a smoking history of > 5 pack-years.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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ACOS smoking history >20 pack-years
Subjects with asthma-COPD overlap syndrome
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IRAO smoking history <5 pack-years
Subjects with an incomplete reversibility of airway obstruction
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total asthma control questionnaire (ACQ) score
Periodo de tiempo: Baseline
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Measurement of asthma control using a 0-6 scale.
The questionnaire includes 6 questions.
Total score is the mean of the scores from all questions.
Total score ranges from 0 to 6.
A lower score is better.
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Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Spirometry results
Periodo de tiempo: Baseline
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Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC
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Baseline
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Sputum eosinophil percentage
Periodo de tiempo: Baseline
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Percentage of sputum eosinophils
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Baseline
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Concentration of Blood biomarkers
Periodo de tiempo: Baseline
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alpha 1 antitrypsine, C-reactive protein (CRP), fibrinogen
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Baseline
|
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Asthma quality of life questionnaire (AQLQ) score
Periodo de tiempo: Baseline
|
Measurement of asthma quality of life using the Mini asthma quality of life questionnaire.
It is a 7-point scale questionnaire (where 1 is greatest impairment and 7 is least impairment) containing 15 uqestions divided into 4 domains : symptoms (5 items), activity limitation (4 items), emotional function (3 items), and exposure to environmental stimuli (3 items).
during the last 2 weeks.
The overall score is the mean of all the responses.
Each domain score is calculated from the mean of the items that relate to it.
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Baseline
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Number of patients with comorbidities
Periodo de tiempo: Baseline
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gastro-oesophageal reflux disease (GERD), obstructive sleep apnea (OSA), anxiety, depression
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Baseline
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Number of asthma exacerbations in the previous year
Periodo de tiempo: Baseline
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emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits
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Baseline
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Change from baseline total Asthma Control Questionnaire (ACQ) score at one-year follow-up
Periodo de tiempo: Baseline to one-year follow-up
|
Measurement of asthma control using a 0-6 scale.
The questionnaire includes 6 questions.
Total score is the mean of the scores from all questions.
Total score ranges from 0 to 6.
A lower score is better.
|
Baseline to one-year follow-up
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Change from baseline number of exacerbations at one-year follow-up
Periodo de tiempo: Baseline to one-year follow-up
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emergency room (ER) visits, hospitalizations, oral corticosteroids treatment, unscheduled medical visits
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Baseline to one-year follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de marzo de 2014
Finalización primaria (Actual)
1 de diciembre de 2016
Finalización del estudio (Actual)
1 de diciembre de 2017
Fechas de registro del estudio
Enviado por primera vez
13 de enero de 2016
Primero enviado que cumplió con los criterios de control de calidad
24 de enero de 2019
Publicado por primera vez (Actual)
25 de enero de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
24 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CÉR21047
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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