Predicting outcome using systemic markers In severe exacerbations of chronic obstructive pulmonary disease

ISRCTN	ISRCTN99586989
DOI	https://doi.org/10.1186/ISRCTN99586989
Protocol serial number	N/A
Sponsor	University Hospital Basel (Switzerland)
Funder	University Hospital Basel (Switzerland)

Submission date: 15/02/2008
Registration date: 16/04/2008
Last edited: 23/03/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Daiana Stolz
Scientific

Clinic of Pulmonary Medicine and Respiratory Cell Research
University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland

Phone	+41 (0)61 265 5184
Email	dstolz@uhbs.ch

Study information

Primary study design	Observational
Study design	International multicentrre longitudinal closed observational cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	PRedicting Outcome using systemic Markers In Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): the PROMISE-COPD cohort study
Study acronym	PROMISE-COPD
Study objectives	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(s)	Ethics Committee of Basel (Ethikkommission Beider Basel) (Switzerland), 24/09/2007, ref: EKBB 295/07
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key 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 Added 27/10/2010: 3. Measurement of daily physicial activity as assessed by a triaxial accelerometer at stable phase of the disease and exacerbation
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	600
Key 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
Key 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
Date of first enrolment	01/01/2008
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Belgium
Germany
Greece
Italy
Netherlands
Serbia
Spain
Switzerland

Study participating centre

University Hospital Basel

Basel
4031
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	18/12/2015		Yes	No
Results article	results	21/03/2018		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

23/03/2018: Publication reference added.
12/07/2016: Publication reference added.
27/10/2010: The overall trial end date was changed from 31/12/2011 to 31/12/2012.