Official Title: “An 8 Week Non-Selected Cohort Study to Investigate Whether the Treatment of Reflux Induced Cough Alters Associated Bronchial Hyper-Responsiveness”

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.

Study Type: Interventional

Study Design: Health Services Research, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: Losec and Zantac
  • Anti-reflux medications

Primary Measures

• Reduction in methacholine sensitivity
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• nprovement in cough symptoms measured using Leicester cough questionnaire
  • Time Frame: 8 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust

Overall Clinical Trial Officials and Contacts

Overall Contact: Hazel Brook 44-014-8262-4067 h.brook@hull.ac.uk

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668317

Study ID Number: 2006-004102-13

ClinicalTrials.gov Identifier: NCT00668317

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency