Status:
TERMINATED
Bronchial Hyper-responsiveness in Reflux Cough
Lead Sponsor:
Hull University Teaching Hospitals NHS Trust
Conditions:
Cough
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00668317
Start Date
September 1 2006
End Date
January 1 2010
Last Update
July 23 2019
Active Locations (1)
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1
Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ