Bronchial Hyper-responsiveness in Reflux Cough

NHS Trust

Status and phase

Terminated

Phase 3

Conditions

Cough

Treatments

Drug: Omeprazole

Drug: Ranitidine

Study type

Interventional

Funder types

Other

Identifiers

NCT00668317

2006-004102-13

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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