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Bronchial Hyper-responsiveness in Reflux Cough

Primary Purpose

Cough

Status

Terminated

Phase

Phase 3

Locations

United Kingdom

Study Type

Interventional

Intervention

Omeprazole

Ranitidine

About this trial

This is an interventional health services research trial for Cough focused on measuring Hyper-responsiveness, reflux cough

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

omeprazole and ranitidine

Arm Description

20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire

Full Information

NCT ID

NCT00668317

First Posted

April 24, 2008

Last Updated

July 12, 2019

Sponsor

Hull University Teaching Hospitals NHS Trust

1. Study Identification

Unique Protocol Identification Number

NCT00668317

Brief Title

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

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Terminated

Why Stopped

Primary care physicians began prescribing antacid therapy for chronic cough

Study Start Date

September 2006 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hull University Teaching Hospitals NHS Trust

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cough

Keywords

Hyper-responsiveness, reflux cough

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

omeprazole and ranitidine

Arm Type

Other

Arm Description

20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte

Intervention Type

Drug

Intervention Name(s)

Omeprazole

Other Intervention Name(s)

Losec

Intervention Description

20 mg BD tablet 8 weeks duration

Intervention Type

Drug

Intervention Name(s)

Ranitidine

Other Intervention Name(s)

Zantac

Intervention Description

300 mg od nocte tablet 8weeks duration

Primary Outcome Measure Information:

Title

Change in Methacholine Sensitivity

Description

Time Frame

baseline and 8 weeks

Secondary Outcome Measure Information:

Title

Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alyn H Morice, Professor

Organizational Affiliation

Hull University Teaching Hospitals NHS Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital

City

Cottingham

State/Province

East Yorkshire

ZIP/Postal Code

HU16 5JQ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

11678780

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.

Results Reference

background

Links:

URL

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2014577/

Description

Publication Link

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Bronchial Hyper-responsiveness in Reflux Cough

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