Airway Inflammation, Symptoms and Lung Function in COPD

NCT01216592 | Completed

• 1 other identifier: ISLCOPD01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Airway inflammation; Symptoms; Lung function; Correlation

Outcome Measures

Primary Outcomes (1)

• Correlation between changes in airway inflammation and symptom score

  Correlation between changes in airway inflammation and symptom score will be evaluated

  1 month,

Secondary Outcomes (3)

• Correlation between changes in airway inflammation and lung function

  1 month

• Correlations between airway inflammation and symptom scores

  1 month

• Correlations between airway inflammation and lung function

  1 month

Study Arms (1)

COPD

Other: COPD treatment

Interventions

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.

COPD

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead
• AstraZeneca: collaborator

Study Sites (1)

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

Ferrara, 44121, Italy

Location

Related Publications (1)

• Contoli M, Baraldo S, Conti V, Gnesini G, Marku B, Casolari P, Scrigner P, Morelli P, Saetta M, Spanevello A, Papi A. Airway inflammatory profile is correlated with symptoms in stable COPD: A longitudinal proof-of-concept cohort study. Respirology. 2020 Jan;25(1):80-88. doi: 10.1111/resp.13607. Epub 2019 Jun 28.

  PMID: 31251440 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Sputum cells.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Alberto Papi, MD

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: January 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 6, 2011

Record last verified: 2011-12

Locations

IT (1)