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 |
| Secondary identifying numbers | N/A |
- 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
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
| Study design | Randomised, active controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 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(s) | Ethics approval received from the local medical ethics committee |
| 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 |
| Primary outcome measure | Improvement in patients' health (faster recovery). |
| Secondary outcome measures | The health care process (use of antibiotics and health care services). |
| Overall study start date | 01/11/2004 |
| Overall study end date | 01/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 128 |
| 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 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
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
University Maastricht (The Netherlands)
University/education
University/education
CAPHRI Research Institute
P.O. Box 616
Maastricht
6200 MD
Netherlands
"ROR" |
https://ror.org/02jz4aj89 |
|---|
Funders
Funder type
Industry
Pfizer (The Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
- Location
- United States of America
Boehringer Ingelheim (The Netherlands)
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, BI, BIPI
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration 2008 results published in thesis https://pure.uva.nl/ws/files/1587855/59316_thesis.pdf (added 12/04/2021) |
| IPD sharing plan |
Editorial Notes
12/04/2021: Publication reference added.
