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

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

Status: Unknown

Conditions: COPD Exacerbation

Study type: Observational

Funder types: Other

Identifiers

NCT02264483

IIBSP-EPO-2013-152

Details and patient eligibility

About

* 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.).

Trial design

150 participants in 2 patient groups

COPD exacerbation

Description:

No intervention. The subjects will be divided in 2 subgroups according to the image study: * COPD exacerbation with pneumonia * COPD exacerbation without pneumonia

COPD stable patients