Bronchial Hyper-responsiveness in Reflux Cough

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cough

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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omeprazole and ranitidine

20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte

Group Type OTHER

Omeprazole

Intervention Type DRUG

20 mg BD tablet 8 weeks duration

Ranitidine

Intervention Type DRUG

300 mg od nocte tablet 8weeks duration

Interventions

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Omeprazole

20 mg BD tablet 8 weeks duration

Intervention Type DRUG

Ranitidine

300 mg od nocte tablet 8weeks duration

Intervention Type DRUG

Other Intervention Names

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Losec Zantac

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No