Airway Inflammation, Symptoms and Lung Function in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Correlations Between Airway Inflammation, Symptoms and Lung Functions in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216592
• Other study ID #: ISLCOPD01
• Status: Completed
• Phase: N/A
• First received: October 6, 2010
• Last updated: December 4, 2011
• Start date: January 2009
• Est. completion date: July 2011

Study information

• Verified date: December 2011
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• COPD treatment
Patients, will be asked to continue their previous medication (GOLD guidelines) during the study. No interventional change in COPD treatment will be performed during the study.

Locations

Country	Name	City	State
Italy	Research Centre on Asthma and COPD - Department of Clinical and Experimental Medicine - Section of Respiratory Disease - University of Ferrara	Ferrara

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara	AstraZeneca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between changes in airway inflammation and symptom score	Correlation between changes in airway inflammation and symptom score will be evaluated	1 month,	No
Secondary	Correlation between changes in airway inflammation and lung function	Correlation between changes in airway inflammation and lung function will be evaluated	1 month	No
Secondary	Correlations between airway inflammation and symptom scores	Correlation between markers of airway inflammation and symptom score will be performed	1 month	No
Secondary	Correlations between airway inflammation and lung function	Correlation between markers of airway inflammation and lung function will be assessed	1 month	No