Treatment of exacerbations of Chronic Obstructive Pulmonary Disease - a co-operation between primary health care and hospital care: a prospective, randomised trial
| ISRCTN | ISRCTN43868741 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43868741 |
| Protocol serial number | N/A |
| Sponsor | University Maastricht (The Netherlands) |
| Funders | Pfizer (The Netherlands), Boehringer Ingelheim (The Netherlands) |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 12/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr B.M. Roede
Scientific
Scientific
Academic Medical Center (AMC)
University of Amsterdam
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 5668983 |
|---|---|
| I.Roede@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group, multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Treatment of exacerbations of Chronic Obstructive Pulmonary Disease - a co-operation between primary health care and hospital care: a prospective, randomised trial |
| Study acronym | PICASSO (Partners in Care Solutions) for COPD |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) | Improvement in patients' health (faster recovery). |
| Key secondary outcome measure(s) | The health care process (use of antibiotics and health care services). |
| Completion date | 01/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 128 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/05/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/04/2021: Publication reference added.
