Bronchial Hyper-responsiveness in Reflux Cough

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust; Hull University Teaching Hospitals NHS Trust
• Treatments: Omeprazole; Ranitidine; Ranitidine bismuth citrate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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