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Airway Inflammation, Symptoms and Lung Function in COPD

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01216592
Enrollment
40
Registered
2010-10-07
Start date
2009-01-31
Completion date
2011-07-31
Last updated
2011-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Airway inflammation, Symptoms, Lung function, Correlation

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.

Interventions

OTHERCOPD 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.

Sponsors

AstraZeneca
CollaboratorINDUSTRY
Università degli Studi di Ferrara
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Correlation between changes in airway inflammation and symptom score1 month,Correlation between changes in airway inflammation and symptom score will be evaluated

Secondary

MeasureTime frameDescription
Correlation between changes in airway inflammation and lung function1 monthCorrelation between changes in airway inflammation and lung function will be evaluated
Correlations between airway inflammation and symptom scores1 monthCorrelation between markers of airway inflammation and symptom score will be performed
Correlations between airway inflammation and lung function1 monthCorrelation between markers of airway inflammation and lung function will be assessed

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026