Low-dose CT for Diagnosis of Pneumonia in COPD Exacerbations and Comparison of the Inflammatory Profile.

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

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-06-30

Brief Summary

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\* Hypothesis: There is an underdiagnosis of pneumonia in COPD (Chronic Obstructive Pulmonary Disease) exacerbations which could be demonstrated by performing low-dose chest CT. Differences in the inflammatory profile in sputum and blood in patients with and without pneumonia can be seen.

\* Objective: To assess the degree of underdiagnosis of pneumonia in COPD exacerbations, using chest low-dose CT and to compare clinical and inflammatory differences in blood and sputum between patients with and without pneumonia.

\*Material and Methods: Prospective observational study including 75 patients with the diagnosis of COPD at the time of an exacerbation and with criteria for a respiratory tract infection. At the time of inclusion clinical features, blood and sputum analysis, chest X-ray and chest low-dose CT are performed. The investigators divide the patients into two groups according to the existence of pneumonia and the inflammatory pattern in blood (inflammatory markers) and sputum (cell populations and inflammatory markers) is compared between the two branches.

Detailed Description

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Conditions

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COPD Exacerbation

Keywords

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Pneumonia in COPD exacerbation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD exacerbation

No intervention.

The subjects will be divided in 2 subgroups according to the image study:

* COPD exacerbation with pneumonia
* COPD exacerbation without pneumonia

No interventions assigned to this group

COPD stable patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* clinical and spirometric diagnosis of COPD.
* for study group: clinical symptoms of exacerbation and infection of low airway.
* Signed informed consent.

Exclusion Criteria

* No acceptance of informed consent.
* The STUDY GROUP: treatment with antibiotic more tan 2 days before consultation.
* Another entity known pulmonology other than COPD (non-obstructive disorders, bronchiectasis, interstitial lung disease patients, severe pulmonary hypertension, hypoventilation).
* Chronic treatment with oral corticosteroids or immunosuppressive drug.
* severe organ comorbidity such as cancer in advanced or terminal phase, pulmonary tuberculosis with important involvement, severe pneumoconiosis.
* Severe alteration of nutritional status.
* Heart disease evolved.
* Limitation for understanding the study (including psychiatric disorder, language problem, social or cultural differences, etc.).

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ingrid Solanes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Laura Sebastian

Role: CONTACT

Email: [email protected]

Facility Contacts

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Sebastian

Role: primary

Other Identifiers

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IIBSP-EPO-2013-152

Identifier Type: -

Identifier Source: org_study_id