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OpenTrials
Completed

NCT Number: NCT01216592

Airway Inflammation, Symptoms and Lung Function in COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Centre on Asthma and COPD - Department of Clinical and Experimental Medicine - Section of Respiratory Disease - University of Ferrara

Ferrara, 44121, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

COPD treatment

Other

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.

Primary outcomes

  1. 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

  1. Correlation between changes in airway inflammation and lung function

    Time frame: 1 month

    Correlation between changes in airway inflammation and lung function will be evaluated

  2. Correlations between airway inflammation and symptom scores

    Time frame: 1 month

    Correlation between markers of airway inflammation and symptom score will be performed

  3. Correlations between airway inflammation and lung function

    Time frame: 1 month

    Correlation between markers of airway inflammation and lung function will be assessed

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 7, 2010
Registry last updated
Dec 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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