Bronchial Hyper-responsiveness in Reflux Cough
This study has been terminated.
(Primary care physicians began prescribing antacid therapy for chronic cough)
Information provided by (Responsible Party):
Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust
First received: April 24, 2008
Last updated: October 16, 2012
Last verified: October 2012
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.
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
||An 8 Week Non-selected Cohort Study to Investigate Whether the Treatment of Reflux Induced Cough Alters Associated Bronchial Hyper-responsiveness
Primary Outcome Measures:
- Change in Methacholine Sensitivity [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
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:
- Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2009 (Final data collection date for primary outcome measure)
Active Comparator: omeprazole and ranitidine
20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte
20 mg BD tablet 8 weeks duration
Other Name: Losec
300 mg od nocte tablet 8weeks duration
Other Name: Zantac
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668317
|Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital
|Cottingham, East Yorkshire, United Kingdom, HU16 5JQ |
Hull and East Yorkshire Hospitals NHS Trust
||Alyn H Morice, Professor
||Hull and East Yorkshire Hospitals NHS Trust
No publications provided
||Prof A H Morice, Professor of Respiratory Medicine, Hull and East Yorkshire Hospitals NHS Trust
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 24, 2008
|Results First Received:
||March 16, 2012
||October 16, 2012
||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:
ClinicalTrials.gov processed this record on March 25, 2015
Respiratory Tract Diseases
Histamine H2 Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs