Cough Responses to Tussive Agents in Health and Disease
Colección de datos
Recopilados desde hoy en adelante - ProspectivoEnfermedades bronquiales+14
+ Tos
+ Tos crónica
Cohorte
Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.Resumen
Fecha de inicio: 1 de noviembre de 2009
Fecha en la que se inscribió al primer participante.Coughing is a distressing symptom which has a major impact on quality of life. It has been estimated that cough costs the UK economy £1 billion each year. Currently there are no effective anti-tussive agents to treat subjects with cough. Although drugs such as morphine may have some anti-tussive effect, side effects unacceptable. Currently our understanding of the mechanisms which lead to coughing in different diseases is poor. Many mechanistic studies rely on testing the sensitivity of the cough reflex by inhalation of capsaicin (chilli-pepper extract) or citric acid. These challenges do not differentiate well between health and disease or between different disease states. Other agents such as prostaglandins and bradykinin are known to stimulate a coughing but responses to these agents have rarely been used as a measure of cough reflex sensitivity and not been compared to standard challenges. It is clear that patients with common airway diseases such as COPD and asthma cough significantly more than healthy subjects. Moreover subjects presenting with chronic cough have cough rates an order of magnitude higher than most patients with airway disease. These differences are poorly represented by the differences in current cough challenge tests. The investigators hypothesize that patterns of cough responses to different tussive agent may better differentiate between health and different disease states. These patterns may also suggest the different mechanisms leading to cough in different diseases.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 102 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Cohorte
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 75 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * General * Adult subjects aged 18 years and over * Meet criteria for subject groups as outlined below (1) Healthy volunteers * Non-smokers * No history of respiratory disease (2) Healthy smokers * Current smokers with smoking history of ≥10 pack years * Spirometry within normal limits i.e. FEV1\>80% predicted and FEV1/FVC ratio \>75% predicted (3) Asthma * Physician diagnosis of asthma * Airways hyperresponsiveness to methacholine; PC20\<16mg/ml (within last 2 years) * Non-smokers or ex-smoker with smoking history of ≤10 pack years (4) COPD * Physician diagnosis of COPD * Ex-smokers with smoking history of ≥20 pack years * Spirometry demonstrating airflow obstruction i.e. FEV1/FVC ratio \<70% (5) Chronic Cough * History of a dry cough for \>8 weeks * Normal CXR * Non-smokers or ex-smoker with smoking history of ≤10 pack years Exclusion Criteria: * 1\) Symptoms of upper respiratory tract infection within the last 6 weeks 2) Participation in another clinical trial of an investigational drug within the last 4 weeks 3) Use of medication likely to alter cough reflex sensitivity i.e. ACE inhibitors, codeine phosphate, morphine sulphate, 4) Patients with severe respiratory disease i.e. FEV1 \< 1 litre, 5) Significant medical co-morbidities likely to affect ability to participate in the trial or affect cough reflex sensitivity e.g. diabetes, stroke, Parkinson's disease, multiple sclerosis etc.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
University Hospital of South Manchester
Manchester, United KingdomAbrir University Hospital of South Manchester en Google Maps