Cough Responses to Tussive Agents in Health and Disease
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveToux Chronique+16
+ Asthme
+ Maladies bronchiques
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 1 novembre 2009
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.102 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 75 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
University Hospital of South Manchester
Manchester, United KingdomOuvrir University Hospital of South Manchester dans Google Maps