Viral Infections in BAL and Bronchial Biopsies of Stable COPD Patients

NCT02622009 | Completed

• 1 other identifier: 10451
• Study Type: observational
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: The presence of low-grade viral infection in the airways of patients with stable chronic obstructive pulmonary disease (COPD) could potentially have implications in the pathogenesis and progression of the disease, but previous studies have reported very different rates of human rhinovirus (HRV) and respiratory syncytial virus (RSV) genome detection in nasal and sputum samples. However, no study has investigated the presence of these viruses directly in the lungs by bronchoalveolar lavage (BAL) and bronchial biopsies. This study aimed to investigate whether HRV and RSV are present in the lungs of stable COPD patients by performing BAL and bronchial biopsies, and relate their presence with disease severity. Methods: Consecutive patients with stable COPD and control subjects, who underwent diagnostic (e.g., lung cancer) and/or therapeutic (e.g., hemoptysis) fibreoptic bronchoscopy in a university hospital in Athens, Greece, were enrolled. The collected BAL and bronchial biopsies during bronchoscopy were subsequently processed for HRV and RSV RNA detection with real-time polymerase chain reaction (PCR). More specifically, the nucleocapsid gene and 5΄ non-coding region were searched for RSV and HRV detection, respectively.

Conditions

HRV and RSV Presence in the Lungs of Stable COPD Patients.

Keywords

stable COPD; bronchoalveolar lavage; biopsy; HRV; RSV

Outcome Measures

Primary Outcomes (1)

• HRV AND RSV PRESENCE

  A Nucleocapsid (N) gene partial sequence, as well as a 5΄ non-coding region (5΄NCR) partial sequence were amplified for RSV and HRV, respectively.

  7 days

Study Arms (5)

COPD I

BRONCHOSCOPIC PROCEDURE IN COPD PATIENTS STAGE I

Procedure: BRONCHOSCOPIC PROCEDURE

COPD II

BRONCHOSCOPIC PROCEDURE IN COPD PATIENTS STAGE II

Procedure: BRONCHOSCOPIC PROCEDURE

COPD III

BRONCHOSCOPIC PROCEDURE IN COPD PATIENTS STAGE III

Procedure: BRONCHOSCOPIC PROCEDURE

NONSMOKERS

BRONCHOSCOPIC PROCEDURE IN NONSMOKERS

Procedure: BRONCHOSCOPIC PROCEDURE

CURRENT OR EXSMOKERS

BRONCHOSCOPIC PROCEDURE IN CURRENT OR EXSMOKERS

Procedure: BRONCHOSCOPIC PROCEDURE

Interventions

BRONCHOSCOPIC PROCEDURE PROCEDURE

After the routine bronchoscopic inspection of the tracheobronchial tree, the investigators performed BAL from subsegmental bronchi and bronchial biopsies (3-4 per patient) from non infiltrated carina

COPD I; COPD II; COPD III; CURRENT OR EXSMOKERS; NONSMOKERS

Eligibility Criteria

• Age: 51 Years - 76 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We enrolled 31 patients with COPD and 22 control subjects. The most common symptoms were dyspnea (32%), cough (19%) and hemoptysis (13%). Whereas 47% of participants did not mention any symptom, but referred to our department in order to investigate bronchoscopically abnormal radiographic findings revealed in chest computed tomography. The commonest comorbidities of COPD patients were arterial hypertension (47%), hyperlipidemia (20.7%) and coronary artery disease (17%), and of control subjects arterial hypertension (50%), hyperlipidemia (22,7%) and diabetes mellitus type 2 (13,6%).

You may qualify if:

• stable COPD,indication for bronchoscopic procedure

You may not qualify if:

• atopic history, asthma, extensive pleural effusions, bronchiectasis, immunosuppression due to chemotherapy or systemic corticosteroids and all the contraindications of the bronchoscopic procedures

Sponsors & Collaborators

• University of Athens: lead

Related Publications (3)

• Falsey AR, Formica MA, Hennessey PA, Criddle MM, Sullender WM, Walsh EE. Detection of respiratory syncytial virus in adults with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2006 Mar 15;173(6):639-43. doi: 10.1164/rccm.200510-1681OC. Epub 2005 Dec 30.

  PMID: 16387798 BACKGROUND

• Seemungal T, Harper-Owen R, Bhowmik A, Moric I, Sanderson G, Message S, Maccallum P, Meade TW, Jeffries DJ, Johnston SL, Wedzicha JA. Respiratory viruses, symptoms, and inflammatory markers in acute exacerbations and stable chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1618-23. doi: 10.1164/ajrccm.164.9.2105011.

  PMID: 11719299 BACKGROUND

• Sethi S, Maloney J, Grove L, Wrona C, Berenson CS. Airway inflammation and bronchial bacterial colonization in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2006 May 1;173(9):991-8. doi: 10.1164/rccm.200509-1525OC. Epub 2006 Feb 10.

  PMID: 16474030 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

BAL and bronchial biopsies

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• GEORGIOS ARSENIS, PROFESSOR

  University of Athens

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Respiratory Medicine

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 4, 2015
• Study Start: November 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 7, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share