Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Exacerbations and Health Related Quality of Life in Chronic Obstructive Pulmonary Disease: CRECOPD Study
Chronic obstructive pulmonary disease (COPD) exacerbation is a major cause of physician
visits and hospital admissions associated with acute respiratory failure, causing increased
morbidity and premature mortality and thus it can significantly affect Health Related
Quality of Life (HRQoL).
Previous studies suggested that patients who have experienced frequent exacerbation present
worse HRQoL compared to patients with infrequent exacerbations. However, there are still
questions regarding the relationship between HRQoL and exacerbations.
In the present study the investigators will study a cohort of COPD patients over 6 years,
they will document exacerbations, they will assess lung emphysema by computed tomography of
the chest and they will evaluate health related quality of life in COPD patients.
The investigators hypothesize that the extend of emphysema in COPD patients is positively
correlated with worsen Health related quality of life (HRQoL).
Chronic obstructive pulmonary disease (COPD) is characterized by progressive loss of lung
function and recurrent exacerbations. COPD exacerbation is a major cause of physician visits
and hospital admissions associated with acute respiratory failure, causing increased
morbidity and premature mortality and thus it can significantly affect HRQoL.
Previous studies suggested that patients who have experienced frequent exacerbation present
worse HRQoL compared to patients with infrequent exacerbations. However, there are still
questions regarding the relationship between HRQoL and exacerbations. Only few studies which
are not an integral part of a clinical trial investigated the relationship between
exacerbations and long-term impairment of HRQoL. Furthermore, a recent study failed to show
that exacerbations remain a significant determinant of HRQoL when several other prognostic
factors were taken into account. In addition, there is luck of data regarding differences in
HRQoL between patients with different phenotypes (i.e., emphysema or chronic bronchitis
predominance).
In this respect we prospectively study the long term effect of exacerbations on the quality
of life of patients with COPD and we aim to investigate further the relationship between
exacerbations and HRQoL.
The investigators hypothesize that the extend of emphysema is positively correlated with
worsen Health related quality of life (HRQoL).
Consecutive sampling will be used to recruit patients with a diagnosis of COPD according to
the GOLD definition.Exacerbations will be identified as worsening of patient's respiratory
signs as recorded on diary cards. HQoL will be assessed using the Saint George Respiratory
Questionaire (SGRQ). Patients will undergo high resolution computed tomography of the
chest(HRCT). Multiple linear regression analysis will be used to identify factors which
explain SGRQ deterioration over the study period for the entire population and for smokers
and ex-smokers separately.
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Observational Model: Cohort, Time Perspective: Prospective
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