Condition category
Respiratory
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
14/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.picassovoorcopd.nl

Contact information

Type

Scientific

Primary contact

Dr B.M. Roede

ORCID ID

Contact details

Academic Medical Center (AMC)
University of Amsterdam
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5668983
I.Roede@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PICASSO (Partners in Care Solutions) for COPD

Study hypothesis

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)?

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic Obstructive Pulmonary Disease (COPD)

Intervention

Control arm: patients with exacerbation COPD receive 'care as usual'.
Intervention arm: patients with exacerbations are treated by their General Practitioner (GP) following the study protocol. This means a short course of oral steroids (30 mg daily, seven to ten days, in accordance with the Dutch College of General Practitioners [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 one-time consultation.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Improvement in patients' health (faster recovery).

Secondary outcome measures

The health care process (use of antibiotics and health care services).

Overall trial start date

01/11/2004

Overall trial end date

01/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient meets the clinical criteria of Chronic Obstructive Pulmonary Disease (COPD):
a. Chronic bronchitis: chronic cough and sputum production on most days during at least three months of the year, during at least two consecutive years and/or
b. COPD defined as an expiratory flow obstruction determined by spirometry, where the disorder does not vary seriously during several months of observation
2. Diagnosis of COPD in medical dossier
3. Indications for exacerbation
a. Increased dyspnoe, +/- accompanied by increased volume and/or purulence of sputum and/or cough
b. Increased dyspnoe developed in a short period (less than four weeks)
c. Adaptation in medication is necessary

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

128

Participant exclusion criteria

1. 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: Acquired Immune Deficiency Syndrome (AIDS), neutropenia less than 1.0 x 10^9/l
6. Age less than 40 or more than 80 years

Recruitment start date

01/11/2004

Recruitment end date

01/05/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

University Maastricht (The Netherlands)

Sponsor details

CAPHRI Research Institute
P.O. Box 616
Maastricht
6200 MD
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Pfizer (The Netherlands)

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Boehringer Ingelheim (The Netherlands)

Alternative name(s)

Boehringer Ingelheim Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes