Exacerbations and Health Related Quality of Life in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Exacerbations and Health Related Quality of Life in Chronic Obstructive Pulmonary Disease: CRECOPD Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00884975
• Other study ID #: DM19021970DM
• Status: Active, not recruiting
• Phase: N/A
• First received: April 20, 2009
• Last updated: April 20, 2009
• Start date: May 2002
• Est. completion date: June 2009

Study information

• Verified date: April 2009
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• chronic Obstructive Lung Disease diagnosis

• ability to perform spirometry

Exclusion Criteria:

• previously diagnosed or clinically evident bronchiectasis

• history of Asthma or other respiratory disease

• continuous use of systemic steroids more than 30 days in the previous year

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly