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Treatment of exacerbations of COPD: a co-operation between primary health care and hospital care. A prospective, randomized trial.


- candidate number0
- NTR NumberNTR72
- ISRCTNISRCTN43868741
- Date ISRCTN created12-sep-2005
- date ISRCTN requested15-aug-2005
- Date Registered NTR5-jul-2005
- Secondary IDsN/A 
- Public TitleTreatment of exacerbations of COPD: a co-operation between primary health care and hospital care. A prospective, randomized trial.
- Scientific TitleTreatment of exacerbations of COPD: a co-operation between primary health care and hospital care. A prospective, randomized trial. Will adequate treatment in primary care, supported by a structured co-operation with the hospital, lead to improvement in patients' health (faster recovery) and the health care process (use of antibiotics and health care services)?
- ACRONYMPICASSO (Partners in Care Solutions) for COPD.
- hypothesisWill adequate treatment in primary care, supported by a structured co-operation with the hospital, lead to improvement in patients' health (faster recovery) and the health care process (use of antibiotics and health care services)?
- Healt Condition(s) or Problem(s) studiedChronic Obstructive Pulmonary Disease (COPD), COPD
- Inclusion criteriaPatient meets the clinical criteria of COPD:
1. Chronic bronchitis:
Chronic cough and sputum production on most days during at least 3 months of the year, during at least 2 consecutive years
and/or
2. COPD defined as an expiratory flow obstruction determined by spirometry, which disorder does not vary seriously during several months of observation and
a. Diagnosis COPD in medical dossier and
b. Indications for exacerbation
c. Increased dyspnoe, +/- accompanied by increased volume and/or purulence of sputum and/or cough
d. Increased dyspnoe developed in a short period (< 4 weeks) and
e. Adaptation in medication is necessary.
- Exclusion criteria1. Inadequate cognitive functioning;
2. Inadequate of mastering the Dutch language;
3. Terminal patient;
4. Other infection at the same time that needs antibiotic treatment;
5. Serious underlying diseases: AIDS, neutropenia < 1,0 x 109/l;
6. Age < 40 or > 80 years.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2004
- planned closingdate1-mei-2006
- Target number of participants128
- InterventionsControl arm:
patients with exacerbation COPD receive 'care as usual'.
Intervention arm:
patients with exacerbations are treated by their GP following the study protocol. This means a short course of oral steroids (30 mg. daily, 7-10 days, in accordance with the NHG guideline for COPD). Antibiotics should be prescribed following the NHG guideline for COPD.
There is an extra opportunity to refer to a pulmonologist for a onetime consultation.
- Primary outcomeImprovement in patients' health (faster recovery).
- Secondary outcomeThe health care process (use of antibiotics and health care services).
- TimepointsN/A
- Trial web sitehttp://www.picassovoorcopd.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. B.M. Roede
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.M. Prins
- Sponsor/Initiator Academic Medical Center (AMC), Department of infectious diseases
- Funding
(Source(s) of Monetary or Material Support)
Pfizer, Boehringer Ingelheim, University Maastricht (UM) CAPHRI Institute
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD8-aug-2005 - 11-nov-2008


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