Bronchial Hyper-Responsiveness in Reflux Cough
Information source: Hull and East Yorkshire Hospitals NHS Trust
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Reflux Cough
Intervention: Losec and Zantac (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hull and East Yorkshire Hospitals NHS Trust Overall contact:
Hazel Brook, Phone: 44-014-8262-4067, Email: h.brook@hull.ac.uk
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.
Clinical Details
Official title: An 8 Week Non-Selected Cohort Study to Investigate Whether the Treatment of Reflux Induced Cough Alters Associated Bronchial Hyper-Responsiveness
Study design: Health Services Research, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Reduction in methacholine sensitivity
Secondary outcome: nprovement in cough symptoms measured using Leicester cough questionnaire
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Hazel Brook, Phone: 44-014-8262-4067, Email: h.brook@hull.ac.uk
Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital, Cottingham, East Yorkshire HU16 5JQ, United Kingdom; Recruiting
Hazel Brook, Phone: 44-014-8262-4067, Email: h.brook@hull.ac.uk
Alyn H Morice, MBB,MA,FRCP, Principal Investigator
Additional Information
Starting date: September 2006
Ending date: December 2008
Last updated: April 24, 2008
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