Airway Inflammation, Symptoms and Lung Function in COPD

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Alberto Papi, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT01216592
First received: October 6, 2010
Last updated: December 4, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: COPD treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlations Between Airway Inflammation, Symptoms and Lung Functions in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Ferrara:

Primary Outcome Measures:
  • Correlation between changes in airway inflammation and symptom score [ Time Frame: 1 month, ] [ Designated as safety issue: No ]
    Correlation between changes in airway inflammation and symptom score will be evaluated


Secondary Outcome Measures:
  • Correlation between changes in airway inflammation and lung function [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Correlation between changes in airway inflammation and lung function will be evaluated

  • Correlations between airway inflammation and symptom scores [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Correlation between markers of airway inflammation and symptom score will be performed

  • Correlations between airway inflammation and lung function [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Correlation between markers of airway inflammation and lung function will be assessed


Biospecimen Retention:   Samples With DNA

Sputum cells.


Enrollment: 40
Study Start Date: January 2009
Study Completion Date: July 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
COPD 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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Moderate to severe COPD patients (according to GOLD guidelines) will be enrolled in the study

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216592

Locations
Italy
Research Centre on Asthma and COPD - Department of Clinical and Experimental Medicine - Section of Respiratory Disease - University of Ferrara
Ferrara, Italy, 44121
Sponsors and Collaborators
Università degli Studi di Ferrara
AstraZeneca
Investigators
Principal Investigator: Alberto Papi, MD Università degli Studi di Ferrara
  More Information

No publications provided

Responsible Party: Alberto Papi, Professor, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT01216592     History of Changes
Other Study ID Numbers: ISLCOPD01
Study First Received: October 6, 2010
Last Updated: December 4, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Università degli Studi di Ferrara:
COPD
Airway inflammation
Symptoms
Lung function
Correlation

Additional relevant MeSH terms:
Lung Diseases
Inflammation
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014