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

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

* 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.

Study Overview

• Status: Unknown
• Conditions: COPD Exacerbation

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Laura Sebastian; Email: lsebastian@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Sebastian; Email: lsebastian@santpau.cat
    • Sub-Investigator: Laura Sebastian, MD
    • Sub-Investigator: Tomas Franquet, MD PhD
    • Sub-Investigator: Ana M Giménez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

COPD patients with an exacerbation of their disease and symptoms of respiratory infection, wich come to visit at outpatient pneumologic clinic.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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
COPD stable patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Sociedad Española de Neumología y Cirugía Torácica
• Investigators: Principal Investigator: Ingrid Solanes, MD PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: September 12, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Estimate): August 31, 2015
• Last Update Submitted That Met QC Criteria: August 28, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Pneumonia in COPD exacerbation
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pneumonia
• Other Study ID Numbers: IIBSP-EPO-2013-152