An 8 week, non-selected, cohort, study to investigate whether the treatment of reflux induced cough alters associated bronchial hyperresponsiveness. - Bronchial Hyper-responsiveness and Reflux Cough

Phase 1

Active, not recruiting

• Conditions: Bronchial hyper-responsiveness in relation to reflux associated chronic cough; MedDRA version: 8.1Level: HLTClassification code 10011233Term: Coughing and associated symptoms

• Registration Number: EUCTR2006-004102-13-GB
• Lead Sponsor: Hull and east yorkshire Hospitals Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-18
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male and female subjects of atleast 18yrs of age
Patients diagnosed with reflux associated chronic cough
Positive Methacholine challenge test PC20Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

FEV1<60% predicted
Subjects who are taking angiotensin converting enzyme inhibitors (ACE)
Subjects with significant pathology on most recent X-Ray
Patients already recieving or have taken in the last month a proton pump inhibitor combined with a H2 receptor antagonist (full acid suppression)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Studying newly diagnosed reflux associated chronic cough patients to identify those with associated hyperesponsive airways to methacholine challenge with porimary objective to determine the effects of 8 weeks anti-reflux therapy (full acid suppression) on bronchial hyper-responsiveness. ;Secondary Objective: Secondary objectives are to determine any change in cough and associated reflux symptoms through measurement of cough specific LPR score, spirometry cough challenge and cough severity scores.;Primary end point(s): Primary end point will be change in methacholine challenge PC20 from baseline to that post 8 weeks full acid suppression