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17 May 2008
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| [ Print-friendly version ] |
| PRedicting Outcome using systemic Markers In Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) - The PROMISE-COPD Cohort Study |
| ISRCTN | ISRCTN99586989 |
| ClinicalTrials.gov identifier | |
| Public title | PRedicting Outcome using systemic Markers In Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) - The PROMISE-COPD Cohort Study |
| Scientific title | |
| Acronym | PROMISE-COPD Study |
| Serial number at source | N/A |
| Study hypothesis |
Circulating biomarkers might be able to predict exacerbations during the stable state of the disease and the clinical outcome of the exacerbations in patients with COPD. Thus, we aim to:
1. Describe the four-week course of clinical, laboratorial, and lung function parameters during exacerbations of COPD as compared to the stable state of the disease 2. Explore predictors that might identify recurrence and poor outcome in the stable state and during exacerbations 3. Analyze the potential of circulating biomarkers for the diagnosis and prognosis of COPD in the stable state and during exacerbations, including a correlation with the number of hospitalizations and death of any cause 4. Assess whether easily to determine circulating biomarkers are capable to replace the widely accepted BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index as predictor of long term prognosis in COPD 5. Analyze the impact of viral and bacterial infections as well as pulmonary embolism on in-hospital and long-term clinical outcomes |
| Ethics approval |
Main approval: Ethics Committee of Basel (Ethikkommission Beider Basel), Switzerland. Date of approval: 24/09/2007 (ref: EKBB 295/07)
The study protocol is being submitted to ethics committees for all other trial centres. |
| Study design | International, multicentric, longitudinal, closed observational cohort study . |
| Countries of recruitment | Switzerland, Netherlands, Spain, Greece, Italy and United States of America. |
| Disease/condition/study domain | Chronic Obstructive Pulmonary Disease (COPD) |
| Participants - inclusion criteria |
1 Age above 40 years, both men and women
2. Smoking history >= 10 pack years 3. Moderate to very severe COPD (GOLD II to IV) 4. Currently stable disease (at least 4 weeks after resolution of the last exacerbation) 5. Willingness to participate in a longitudinal, cohort study 6. Willingness of the family physician to have the patient included in a cohort study 7. Written informed consent |
| Participants - exclusion criteria |
1. Rapid fatal disease
2. Pulmonary condition other than COPD as the main respiratory disease, e.g. bronchiectasis, asthma or pulmonary fibrosis 3. Immunosuppression including HIV, organ transplantation or chronic steroid use (more than 10 mg prednisolone-equivalent per day) 4. Patients unable and unwilling to give written informed consent 5. Musculoskeletal process preventing ambulation |
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 31/12/2011 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 600 |
| Interventions | COPD will be diagnosed according to the Chronic Obstructive Lung Disease (GOLD) guidelines (FEV1/FVC ratio below 70% and an absolute reduction of FEV1 below 80% of the predicted value). Acute exacerbation of COPD will be defined as "an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD." |
| Primary outcome measure(s) |
Clinical end-points include the following (Duration of follow-up: Two years):
1. Number of exacerbations, including exacerbations requiring hospitalization and exacerbations managed by the primary care physicians 2. Number of deaths of any cause 3. Number of respiratory-related deaths 4. Time to next exacerbation, time to next exacerbation requiring hospitalization and time to death 5. Duration of hospitalization 6. Admission and length of stay in intensive care unit 7. Need for intubation or non-invasive ventilation 8. Need for oral steroids and antibiotics 9. Lung function and 6-minute walk test changes |
| Secondary outcome measure(s) |
1. Quality of life assessed by Saint Georges Respiratory Questionnaire and the 36-item Short Form health survey (SF-36) at every scheduled visits during the follow-up phase (every 6 months) and 4 weeks after an exacerbation
2. Dyspnea and respiratory symptoms as assessed by the Modified Medical Research Council (MMRC) scale and Lower Respiratory Tract Illness - Visual Analogue Scale (LRTI-VAS) at every scheduled visits during the follow-up phase (every 6 months) and 4 weeks after an exacerbation |
| Sources of funding | University Hospital Basel (Switzerland) |
| Trial website | |
| Publications | |
| Contact name | Dr Daiana Stolz |
| Address |
Clinic of Pulmonary Medicine and Respiratory Cell Research
University Hospital Basel Petersgraben 4 |
| City/town | Basel |
| Zip/Postcode | 4031 |
| Country | Switzerland |
| Tel | +41 61 265 5184 |
| Fax | +41 61 265 45 87 |
| dstolz@uhbs.ch | |
| Sponsor | University Hospital Basel (Switzerland) |
| Address |
c/o Dr Daiana Stolz
Clinic of Pulmonary Medicine and Respiratory Cell Research Petersgraben 4 |
| City/town | Basel |
| Zip/Postcode | 4031 |
| Country | Switzerland |
| Tel | +41 61 265 5184 |
| Fax | +41 61 265 4587 |
| dstolz@uhbs.ch | |
| Sponsor website: | http://www.dfbs.ch |
| Date applied | 15/02/2008 |
| Last edited | 16/04/2008 |
| Date ISRCTN assigned | 16/04/2008 |
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