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

COPD Exacerbation Clinical Trial

Official title:

Assessment of the Degree of Pneumonia Underdiagnosis in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Using Chest Low-dose Computed Tomography (CT) and Comparison of Inflammatory Profile Between the Two Entities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02264483
• Other study ID #: IIBSP-EPO-2013-152
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2014
• Last updated: August 28, 2015
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2015
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Laura Sebastian
• Email: lsebastian[@]santpau.cat
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial Summary

• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.).

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD Exacerbation
• Pneumonia
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with an exacerbation of their disease who have a Pneumonia diagnosed by low dose - CT (not detected by chest X-Ray).		1 year and a half	No