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Helicobacter eradication therapy in Chronic Obstructive Pulmonary Disease: A pilot,randomised, double blinded, placebo controlled trial - COPDHP

Phase 1
Conditions
Chronic Obstructive Airways Disease: Defined as a consistent clinical picture with evidence of airflow obstruction (FEV1 < 70%, FEV1/FVC Ratio <70%, with no evidence of reversibility in FEV1 after 200 micrograms of inhaled salbutamol (<15%, or if FEV1 <1 litre, <200 ml improvement)
Registration Number
EUCTR2006-005382-19-GB
Lead Sponsor
niversity Hospitals of Leicester NHS Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

Patients with Chronic Obstructive Airways Disease ( see E.1 for definition)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age < 18 years
Penicillin allergy
Severe dyspepsia ( at least weekly symptoms either on or off medications)
Patients on PPI who would be unable to stop them for the duration of the study
Patients on long term antibiotics
Patients receiving antibiotics in the 4 weeks prior to start of the study
Patients with liver or kidney disease

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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