Bronchial Hyper-responsiveness in Reflux Cough

An 8 Week Non-selected Cohort Study to Investigate Whether the Treatment of Reflux Induced Cough Alters Associated Bronchial Hyper-responsiveness

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.

Study Overview

• Status: Terminated
• Conditions: Cough
• Intervention / Treatment: Drug: Omeprazole; Drug: Ranitidine

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • East Yorkshire
    • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
      • Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: omeprazole and ranitidine; 20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte	Drug: Omeprazole; 20 mg BD tablet 8 weeks duration; Other Names: Losec; Drug: Ranitidine; 300 mg od nocte tablet 8weeks duration; Other Names: Zantac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Methacholine Sensitivity	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	baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire	8 weeks

Collaborators and Investigators

• Sponsor: Hull University Teaching Hospitals NHS Trust
• Investigators: Principal Investigator: Alyn H Morice, Professor, Hull University Teaching Hospitals NHS Trust

Publications and helpful links

General Publications

• 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.

Helpful Links

• Publication Link

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: April 24, 2008
• First Submitted That Met QC Criteria: April 24, 2008
• First Posted (Estimate): April 29, 2008

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Hyper-responsiveness, reflux cough
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Bronchial Diseases; Signs and Symptoms, Respiratory; Cough; Bronchial Hyperreactivity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists; Omeprazole; Ranitidine; Ranitidine bismuth citrate
• Other Study ID Numbers: 2006-004102-13