Clinical trial NCT00668317: Bronchial Hyper-responsiveness in Reflux Cough
Official title: An 8 Week Non-selected Cohort Study to Investigate Whether the Treatment of Reflux Induced Cough Alters Associated Bronchial Hyper-responsiveness
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cough
Keywords: Hyper-responsiveness, reflux cough
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2008-04-29
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Methacholine Sensitivity
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cottingham
country: United Kingdom
facility: Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital
state: East Yorkshire
Study officials:
affiliation: Hull University Teaching Hospitals NHS Trust
name: Alyn H Morice, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morice AH, Kastelik JA, Thompson R. Cough challenge in the assessment of cough reflex. Br J Clin Pharmacol. 2001 Oct;52(4):365-75. doi: 10.1046/j.0306-5251.2001.01475.x. No abstract available.