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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University of Thessaly.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Thessaly
ClinicalTrials.gov Identifier:
NCT00884975
First received: April 20, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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).


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exacerbations and Health Related Quality of Life in Chronic Obstructive Pulmonary Disease: CRECOPD Study

Resource links provided by NLM:


Further study details as provided by University of Thessaly:

Enrollment: 102
Study Start Date: May 2002
Estimated Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a diagnosis of Chronic Obstructive Lung Disease according to the GOLD definition (Pauwels RA, Buist AS, Calverley PM, et al; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. Am J Respir Crit Care Med. 2001;163(5):1256-76.), who attend outpatient clinics at Chania General Hospital on the island of Crete, Greece

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884975

Sponsors and Collaborators
University of Thessaly
Investigators
Principal Investigator: Demos Makris, MD University of Crete/University of Thessaly
  More Information

No publications provided

Responsible Party: Demosthenes Makris, University of Thessaly
ClinicalTrials.gov Identifier: NCT00884975     History of Changes
Other Study ID Numbers: DM19021970DM
Study First Received: April 20, 2009
Last Updated: April 20, 2009
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by University of Thessaly:
Chronic obstructive pulmonary disease
exacerbations
quality of life
emphysema

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014