Bronchial Hyper-responsiveness in Reflux Cough

Phase 3

Terminated

• Conditions: Cough
• Interventions: Drug: Omeprazole; Drug: Ranitidine

• Registration Number: NCT00668317
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-29
• Primary Completion: 2009-09
• Study Completion: 2010-01
• Results First Submitted: 2012-03-16
• Results First Submitted QC: 2012-10-16
• Results First Posted: 2012-11-16
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
omeprazole and ranitidine	Omeprazole	20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte
omeprazole and ranitidine	Ranitidine	20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte

Primary Outcome Measures

Name	Time	Method
Change in Methacholine Sensitivity	baseline and 8 weeks	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

Secondary Outcome Measures

Name	Time	Method
Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire	8 weeks

Trial Locations

Locations (1)

Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital; 🇬🇧 Cottingham, East Yorkshire, United Kingdom