We aim to (1) describe the 4 weeks 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…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Number of exacerbations during two-year follow-up, including exacerbations
requiring hospitalization and exacerbations managed by the primary care
physicians
• Number of deaths of any cause during the two-year follow-up
• Number of respiratory-related deaths during the two-year follow-up
• Time to next exacerbation, time to next exacerbation requiring
hospitalization and time to death during the two-year follow-up
Secondary outcome
• Length of stay during hospitalization
• Admission and length of stay in intensive care unit
• Need for intubation or non-invasive ventilation
• Need for oral steroids and antibiotics
• Quality of life assessed by Saint Georges Respiratory Questionnaire and SF-36
• Dyspnoea and respiratory symptoms as assessed by the MMRC and LRTI-VAS
• Lung function and 6-minute walk test changes
Background summary
Chronic obstructive pulmonary disease (COPD) is a growing cause of morbidity
and mortality. Exacerbations are now recognized as important events in the
natural course of disease progression consuming enormous health care resources.
There is scarce information about biomarkers able to predict exacerbations
during the stable state of the disease and the clinical outcome of the
exacerbations
Study objective
We aim to (1) describe the 4 weeks 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 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.
Study design
A total of 600 patients with moderate to very severe COPD (GOLD II-IV) willing
to take part in a longitudinal, cohort study will be recruited from lung
function laboratory records of university hospitals. Patients will be
instructed to contact the study site in case of exacerbation of respiratory
symptoms leading to physician contact. Clinical information including quality
of life, sputum, lung function test, exercise capacity, and blood samples will
be obtained at inclusion in the study and at two-year follow-up. Patients will
be invited to attend at total of 4 scheduled visits (6 months, 12 months, 18
months and 24 months). Additionally, clinical information, sputum and blood
samples will be collected during episodes of acute exacerbation. In cases of
acute exacerbation requiring hospitalisation, systematic routine work-up
including chest-X-rays, facultative thoracic CT-scans, facultative
bronchoalveolar lavage and facultative echocardiography will be recommended.
Predictive factors for exacerbation and outcome will be explored using
univariate and multivariate Cox proportional hazard models.
Study burden and risks
RISKS OF STANDARD PROCEDURES BEING DONE FOR PURPOSES OF THE RESEARCH WHICH YOU
MIGHT NOT NEED TO HAVE IF YOU WERE NOT IN THE STUDY
- Discomfort of a puncture
- The lung function test might be tiring for some patients
- Six-minute walk test might be tiring for some patients
- Additive radiation exposure due to chest X-ray and if neccessary CT scan.
Uncommonly, the use of contrast medium (CT scan) might be associated with a
decreased kidney function. Some patients might experience discomfort during the
examination (claustrophobia)
- Bronchoscopy(faculative) causes cough and dyspnea during the procedure
- The patient has to fill in 2 questionnaires and 2 lists with symptoms before
each visit
BENEFITS
You may benefit directly from being in this research study because your health
status is being checked on a regular basis. Moreover, your participation may
help others with this condition in the future as a result of knowledge gained
from the research.
Postbus 501
1800AM Alkmaar
Nederland
Postbus 501
1800AM Alkmaar
Nederland
Listed location countries
Age
Inclusion criteria
• Age above 40 years;
• Smoking history >= 10 pack years;
• Moderate to very severe COPD (GOLD II to IV);
• Currently stable disease (at least 4 weeks after resolution of the last exacerbation);
• Willingness to participate in a longitudinal, cohort study;
• Willingness of the family physician to have the patient included in a cohort study;
• Written informed consent.
Exclusion criteria
• Rapid fatal disease;
• Pulmonary condition other than COPD as the main respiratory disease, e.g. bronchiectasis, asthma or pulmonary fibrosis;
• Immunosuppression including HIV, organ transplantation or chronic steroid use (more than 10mg prednisolone-equivalent per day);
• Patients unable and unwilling to give written informed consent;
• Muskulo-skeletal process preventing ambulation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | ISRTCN |
| CCMO | NL22085.094.08 |