Airway Inflammation, Symptoms and Lung Function in COPD

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: COPD treatment

• Registration Number: NCT01216592
• Lead Sponsor: Università degli Studi di Ferrara

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Primary Completion: 2011-01
• Study Completion: 2011-07
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-04
• Last Update Posted: 2011-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Post-bronchodilator FEV1/FVC ratio < 70%
• Post-bronchodilator FEV1 < 80%
• Smokers or ex-smoker with pack/years > 15

Exclusion Criteria

• Atopy
• Asthma
• Concomitant lung diseases (e.g. lung cancer)
• Acute infections of the respiratory tree in the previous 2 months including COPD exacerbation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD	COPD treatment	-

Primary Outcome Measures

Name	Time	Method
Correlation between changes in airway inflammation and symptom score	1 month,	Correlation between changes in airway inflammation and symptom score will be evaluated

Secondary Outcome Measures

Name	Time	Method
Correlations between airway inflammation and symptom scores	1 month	Correlation between markers of airway inflammation and symptom score will be performed
Correlations between airway inflammation and lung function	1 month	Correlation between markers of airway inflammation and lung function will be assessed
Correlation between changes in airway inflammation and lung function	1 month	Correlation between changes in airway inflammation and lung function will be evaluated

Trial Locations

Locations (1)

Research Centre on Asthma and COPD - Department of Clinical and Experimental Medicine - Section of Respiratory Disease - University of Ferrara; 🇮🇹 Ferrara, Italy