Bronchial Hyper-responsiveness in Reflux Cough

Study Overview
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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.

Official Title
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An 8 Week Non-selected Cohort Study to Investigate Whether the Treatment of Reflux Induced Cough Alters Associated Bronchial Hyper-responsiveness

Conditions
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Cough

Intervention / Treatment
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* Drug: Omeprazole
* Drug: Ranitidine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: omeprazole and ranitidine<br>20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte | Drug: Omeprazole<br>* 20 mg BD tablet 8 weeks duration<br>* Other names: Losec;Drug: Ranitidine<br>* 300 mg od nocte tablet 8weeks duration<br>* Other names: Zantac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Methacholine Sensitivity | Concentration of methacholine (mg/ml) at which participants forced expired volume in 1 sec (FEV1) is reduced by 20% (the provocation concentration of methacholine causing a 20% fall in FEV1-PC20). To measure if there is a significant difference in PC20 recorded at baseline to that recorded following 8 weeks treatment with omeprazole and ranitidine | baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyper-responsiveness, reflux cough