MedPath

ABC-trial.

Completed
Registration Number
NL-OMON25445
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

1. Patients of the outpatient clinic of the Medical Spectrum Twente;

2. Age between 40 and 75;

Exclusion Criteria

1. Serious other disease with a low survival rate;

2. Clinical symptoms (e.g. temperature > 38,5 oC), indicating pneumonia and a thorax X-ray positive for pneumonia;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Duration of the exacerbations. This is measured by a Body Area Network, a symptom diary and lung function (FEV1 and PEF).
Secondary Outcome Measures
NameTimeMethod
1. Severity of the exacerbations. This is measured by a Body Area Network, a symptom diary and lung function (FEV1 and PEF);<br /><br>2. Relapse rate. A relapse is defined as an exacerbation that resolves due to the blinded treatment but re-occurs within 28 days of the treated exacerbation;<br /><br>3. Cost-effectiveness of treatment with antibiotics;<br /><br>4. Use of rescue-medication, recorded in the symptom diary;<br /><br>5. Quality of life, measured by the Chronic Respiratory Questionnaire and the COPD Chronic Questionnaire.
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