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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005382-19-GB

Enrollment

Registered

2007-05-15

Start date

2007-06-22

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

Interventions

Trade Name: Omeprazole Product Name: Omeprazole Product Code: Omeprazole Pharmaceutical Form: Capsule* INN or Proposed INN: OMEPRAZOLE CAS Number: 73590586 Current Sponsor code: Omeprazole Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether eradication therapy for Helicobacter pylori infection improves outcome in patients with COPD as assessed by change in sputum neutrophil count and Chronic Respiratory Disease Questionnaire.;Secondary Objective: To determine whether eradication therapy for Helicobacter pylori infection improves outcome in patients with COPD as assessed by change in MRC Dyspnoea Score, chnage in post-bronchodilator FEV1, change in number of exacerabations, change in Visual Analogue Score for cough, breathlessness and sputum;Primary end point(s): Difference in mean sputum neutrophil count Difference in mean Chronic Respiratory Disease Questionnaire Score (CRQ)	—

Measure

Time frame

Main Objective: To determine whether eradication therapy for Helicobacter pylori infection improves outcome in patients with COPD as assessed by change in sputum neutrophil count and Chronic Respiratory Disease Questionnaire.;Secondary Objective: To determine whether eradication therapy for Helicobacter pylori infection improves outcome in patients with COPD as assessed by change in MRC Dyspnoea Score, chnage in post-bronchodilator FEV1, change in number of exacerabations, change in Visual Analogue Score for cough, breathlessness and sputum;Primary end point(s): Difference in mean sputum neutrophil count Difference in mean Chronic Respiratory Disease Questionnaire Score (CRQ)

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026