The primary aim of this project is to define the role exacerbations play in the pathophysiology of COPD. Moreover, the study has the aim to determine the long-term effects of PR and the natural course of the disease. The unique design of MCC will…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The role of respiratory infections as pathogenic component of COPD
exacerbations;
- The individual response to respiratory pathogens associated with COPD
exacerbations;
- Determination and validation of the COPD phenotypes;
- The natural history of systemic manifestations and co-morbidities of COPD and
their interrelationships, associated to exacerbations;
- The long-term effects of pulmonary rehabilitation;
- The impact of exacerbations during pre-rehabilitation and post-rehabilitation
on health outcomes;
- Short- and long-term mortality.
Secondary outcome
- Formation of a prospective cohort of COPD outpatients at the department of
Respiratory Medicine in Maastricht.
Background summary
COPD is a burdensome chronic disease, which has a huge impact on patient*s
life. Many experience exacerbations, which are acute deteriorations of the
disease and reduce the quality of life, speed the disease progression and
increase the risk of death. Despite the intense research efforts, many
clinically important questions are still un-answered. These questions include:
*Why are some patients susceptible to COPD exacerbations and others not? What
is the role of respiratory infections in this, and how does this affect the
disease progression?
Pulmonary rehabilitation (PR) is recognized as a core-component in the
management of patients with COPD, not only in the stable state, but also
following treatment for an acute exacerbation. The long-term benefits of
pulmonary rehabilitation on patient-related outcomes and exacerbations are
currently unknown. Furthermore, the impact of recurring exacerbations on these
long-term effects are to be researched.
Study objective
The primary aim of this project is to define the role exacerbations play in the
pathophysiology of COPD. Moreover, the study has the aim to determine the
long-term effects of PR and the natural course of the disease. The unique
design of MCC will enable to study these and future hypotheses using the same
patient cohort.
Study design
A prospective single-centre observational cohort study.
Study burden and risks
All patients will have a baseline assessment, possibly as part of the
revalidation. They will have a regular follow-up every three months and when
admitted to the hospital for exacerbations. When hospitalised, follow-up takes
place after 28 days.
Tests can have side effects, think of bruises when taking blood, fatigue during
some tests, or an allergic reaction at a CT-scan. However, these tests are
being used in daily practice, so no additional risks are expected.
Hornerheide 1
Horn 6085 NM
NL
Hornerheide 1
Horn 6085 NM
NL
Listed location countries
Age
Inclusion criteria
- Adults, either sex, older than 40 years of age;
- Smoking history of 10 Pack Years or more;
- Diagnosis of COPD stages I-IV as defined by the Global initiative for chronic Obstructive Lung Disease (GOLD);
- Classified by COPD severity in group B or D, based on the GOLD criteria of COPD severity (Figure 1);
- Patients must be able to complete diaries and quality of life questionnaires;
- Patients must sign and date an informed consent prior to inclusion in the MCC.
Exclusion criteria
- Progressively fatal disease, or life expectancy *6 months;
- Women who are breast feeding or are pregnant;
- Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study;
- Patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study;
- Patients participating in an intervention study.
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 |
|---|---|
| CCMO | NL43896.068.13 |
| Other | Onderzoek wordt geregistreerd zodra goedkeuring is ontvangen (op www.trialregister.nl) |