An 8 Week Non-selected Cohort Study to Investigate Whether the Treatment of Reflux Induced Cough Alters Associated Bronchial Hyper-responsiveness
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Methacholine Sensitivity
研究概览
简要总结
The study aim is to determine the effect of 8 weeks of anti-reflux treatment (full acid suppression) on bronchial hyper-responsiveness and whether there is a symptomatic improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive methacholine challenge test PC20 less than 4mg/ml (Can be previously documented in patients notes within last 4weeks)
- •Written informed consent
- •Patients with a history of chronic cough (at least 3 months duration), and associated symptoms of gastro-oesophageal reflux
- •Male and female subjects of at least 18 yrs of age
- •Subjects able to perform satisfactory FEV1 manoeuvres
- •Subjects able to understand the study and co-operate with the study procedures
- •Subjects who consent to their general practitioner (GP) being informed of their study participation
排除标准
- •has had a heart attack in the last three months
- •suffers from angina, hypertension or ischaemic heart disease
- •has epilepsy for which he/she is taking medication
- •FEV1< 60% predicted
- •FEV1<1.6L
- •Female subjects who are pregnant, or lactating, or who are of child bearing potential but are not using contraceptive measures
- •Suffering from any concomitant disease which may interfere with study procedures or evaluation.
- •A lower respiratory tract infection 4 weeks prior to entry on to study
- •Participation in another study (use of investigational product) within 30 days preceding entry on to study.
- •Alcohol or drug abuse
- •Use of opiates to treat cough 1 week prior to enrollment
- •Subjects who are taking Angiotensin Converting Enzymes (ACE) inhibitors.
- •Subjects who have significant pathology on most recent chest X-Ray.
- •Inability to understand the procedures and the implications of a challenge test
- •Patients already taking or have taken in last 4 weeks PPI and H2 receptor antagonist (full acid suppression treatment
研究组 & 干预措施
omeprazole and ranitidine
20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte
干预措施: Omeprazole (Drug)
omeprazole and ranitidine
20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte
干预措施: Ranitidine (Drug)
结局指标
主要结局
Change in Methacholine Sensitivity
时间窗: baseline and 8 weeks
Concentration of methacholine (mg/ml) at which participants forced expired volume in 1 sec (FEV1) is reduced by 20% (the provocation concentration of methacholine causing a 20% fall in FEV1-PC20). To measure if there is a significant difference in PC20 recorded at baseline to that recorded following 8 weeks treatment with omeprazole and ranitidine
次要结局
- Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire(8 weeks)