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Airway Inflammation, Symptoms and Lung Function in COPD

NCT ID: NCT01216592

Last Updated: 2011-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD Airway inflammation Symptoms Lung function Correlation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD

COPD treatment

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Alberto Papi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberto Papi, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Ferrara

Locations

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

Ferrara, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 31251440 (View on PubMed)

Other Identifiers

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ISLCOPD01

Identifier Type: -

Identifier Source: org_study_id