Condition category
Respiratory
Date applied
15/02/2008
Date assigned
16/04/2008
Last edited
12/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Daiana Stolz

ORCID ID

Contact details

Clinic of Pulmonary Medicine and Respiratory Cell Research
University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland
+41 (0)61 265 5184
dstolz@uhbs.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

PRedicting Outcome using systemic Markers In Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): the PROMISE-COPD cohort study

Acronym

PROMISE-COPD

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 chronic obstructive pulmonary disease (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. Analyse 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 hospitalisations 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. Analyse the impact of viral and bacterial infections as well as pulmonary embolism on in-hospital and long-term clinical outcomes

Ethics approval

Ethics Committee of Basel (Ethikkommission Beider Basel) (Switzerland), 24/09/2007, ref: EKBB 295/07

Study design

International multicentrre longitudinal closed observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

COPD will be diagnosed according to the GOLD guidelines (forced expiratory volume in one second [FEV1]/forced vital capacity [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 characterised 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".

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Clinical end-points include the following (duration of follow-up: two years):
1. Number of exacerbations, including exacerbations requiring hospitalisation 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 hospitalisation and time to death
5. Duration of hospitalisation
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 measures

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

Added 27/10/2010:
3. Measurement of daily physicial activity as assessed by a triaxial accelerometer at stable phase of the disease and exacerbation

Overall trial start date

01/01/2008

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age above 40 years, both men and women
2. Smoking history greater than or equal to 10 pack years
3. Moderate to very severe COPD (Global Initiative for chronic Obstructive Lung Disease [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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant 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 human immunodeficiency virus (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

Recruitment start date

01/01/2008

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Belgium, Germany, Greece, Italy, Netherlands, Serbia, Spain, Switzerland

Trial participating centre

University Hospital Basel
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel (Switzerland)

Sponsor details

c/o Dr Daiana Stolz
Clinic of Pulmonary Medicine and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland
+41 (0)61 265 5184
dstolz@uhbs.ch

Sponsor type

Hospital/treatment centre

Website

http://www.dfbs.ch

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Basel (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26684757

Publication citations

Additional files

Editorial Notes

12/07/2016: Publication reference added. 27/10/2010: the overall trial end date was changed from 31/12/2011 to 31/12/2012.