Bronchial Hyper-responsiveness in Reflux Cough

Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00668317
• Other study ID #: 2006-004102-13
• Status: Terminated
• Phase: Phase 3
• Start date: September 2006
• Est. completion date: January 2010

Study information

• Verified date: July 2019
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchial Hyperreactivity
• Cough

Intervention

Drug:
• Omeprazole
20 mg BD tablet 8 weeks duration
• Ranitidine
300 mg od nocte tablet 8weeks duration

Locations

Country	Name	City	State
United Kingdom	Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital	Cottingham	East Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Morice AH, Kastelik JA, Thompson R. Cough challenge in the assessment of cough reflex. Br J Clin Pharmacol. 2001 Oct;52(4):365-75. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire		8 weeks

External Links

•   Publication Link