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

NCT02264483 | Unknown

• 1 other identifier: IIBSP-EPO-2013-152
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD Exacerbation

Keywords

Pneumonia in COPD exacerbation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Sociedad Española de Neumología y Cirugía Torácica: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples and sputum (supernatant)

Study Officials

• Ingrid Solanes, MD PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Sebastian

CONTACT

lsebastian@santpau.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: October 15, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 31, 2015

Record last verified: 2015-08

Locations

ES (1)