Bronchial Hyper-Responsiveness in Reflux Cough

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2008 by Hull and East Yorkshire Hospitals NHS Trust. Recruitment status was Recruiting

First Received on April 24, 2008. No Changes Posted

Sponsor:	Hull and East Yorkshire Hospitals NHS Trust
Information provided by:	Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier:	NCT00668317

Purpose

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.

Condition	Intervention	Phase
Reflux Cough	Drug: Losec and Zantac	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	An 8 Week Non-Selected Cohort Study to Investigate Whether the Treatment of Reflux Induced Cough Alters Associated Bronchial Hyper-Responsiveness

Resource links provided by NLM:

MedlinePlus related topics: Cough GERD

U.S. FDA Resources

Further study details as provided by Hull and East Yorkshire Hospitals NHS Trust:

Primary Outcome Measures:

Reduction in methacholine sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

nprovement in cough symptoms measured using Leicester cough questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Anti-reflux medications

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668317

Contacts

Contact: Hazel Brook

44-014-8262-4067

h.brook@hull.ac.uk

Locations

United Kingdom
Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital	Recruiting
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Contact: Hazel Brook 44-014-8262-4067 h.brook@hull.ac.uk
Principal Investigator: Alyn H Morice, MBB,MA,FRCP

Sponsors and Collaborators

Hull and East Yorkshire Hospitals NHS Trust

More Information

No publications provided

Responsible Party:	Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier:	NCT00668317 History of Changes
Other Study ID Numbers:	2006-004102-13
Study First Received:	April 24, 2008
Last Updated:	April 24, 2008
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:

Hyper-responsiveness, reflux cough

Additional relevant MeSH terms:

Cough
Gastroesophageal Reflux
Bronchial Hyperreactivity
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on February 09, 2012