Correlations Between Airway Inflammation, Symptoms and Lung Functions in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Università degli Studi di Ferrara
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Correlation between changes in airway inflammation and symptom score
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease with high prevalence worldwide and with relevant impact on patient-related quality of life, morbidity and mortality. There is evidence that airway inflammation correlates with the severity of the disease and that airway inflammation is further enhanced during exacerbation. However, it is unknown whether daily fluctuation of symptoms or changes in lung function is paralleled by changes in airway inflammation.
Detailed Description
Patients will undergo a visit every 7 days during one month (5 visits in total). At each visit airway inflammation (exhaled NO, sputum inflammatory cell count) and lung function will be performed. At home patients will be asked to fill a daily diary for symptom assessment.
Investigators
Alberto Papi
Professor
Università degli Studi di Ferrara
Eligibility Criteria
Inclusion Criteria
- •Post-bronchodilator FEV1/FVC ratio \< 70%
- •Post-bronchodilator FEV1 \< 80%
- •Smokers or ex-smoker with pack/years \> 15
Exclusion Criteria
- •Concomitant lung diseases (e.g. lung cancer)
- •Acute infections of the respiratory tree in the previous 2 months including COPD exacerbation.
Outcomes
Primary Outcomes
Correlation between changes in airway inflammation and symptom score
Time Frame: 1 month,
Correlation between changes in airway inflammation and symptom score will be evaluated
Secondary Outcomes
- Correlations between airway inflammation and symptom scores(1 month)
- Correlations between airway inflammation and lung function(1 month)
- Correlation between changes in airway inflammation and lung function(1 month)