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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00668317
Other study ID # 2006-004102-13
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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