Airway Inflammation and Remodeling in Asthma and COPD.

NCT02069054 | Completed

• 1 other identifier: IPU-DIMPA-WUM13(2)
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma and chronic obstructive pulmonary disease (COPD) are inflammatory airway diseases. Although the clinical features of asthma and COPD may be similar, the pathogenesis of these diseases differs in many aspects. The aim of this study is:

• to evaluate airway inflammation in asthma and COPD,
• to evaluate airway remodeling in asthma and COPD as compared to healthy subjects,
• to assess the relationship between markers of airway inflammation and airway remodeling in asthma and COPD patients. Material and methods:
• mild to moderate asthma patients diagnosed in accordance with Global Initiative for Asthma (GINA) guidelines,
• mild to moderate COPD patients diagnosed in accordance with Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines,
• healthy subjects as controls. Airway inflammation is assessed in induced sputum (IS), exhaled breath condensate (EBC), bronchoalveolar lavage fluid (BALF) and specimens from endobronchial forceps biopsy. Airway wall thickness is evaluated in high resolution computed tomography (HRCT), endobronchial ultrasound (EBUS) and basement membrane thickness (BMT) in biopsy specimens. We plan to compare airway inflammation and features of airway remodeling in asthma and COPD patients.

Conditions

Asthma; COPD

Keywords

asthma; COPD; airway inflammation; remodeling; cytokines; airway wall thickness

Outcome Measures

Primary Outcomes (2)

• Inflammatory markers

  Inflammatory markers in exhaled breath condensate and induced sputum in healthy subjects, COPD and asthma patients.

  Approximately 1-2 months after completion of study procedures (bronchoscopy, induced sputum, etc.) in all patients (probably January 2015)

• Airway wall thickness

  Airway wall thickness in healthy subject, COPD and asthma patients assessed by HRCT and EBUS

  Approximately 1-2 months after completion of study procedures (bronchoscopy with EBUS, HRCT) in all patients (probably January 2015)

Study Arms (3)

Asthma

Patients with mild to moderate asthma diagnosed in accordance with GINA

COPD

Patients with mild to moderate COPD diagnosed in accordance with GOLD

Control

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with stable asthma and COPD invited to Clinical Hospital in Warsaw

You may qualify if:

• a clinical diagnosis of asthma or COPD in accordance with GINA or GOLD, respectively
• control group - healthy volunteers without any history of lung disease

You may not qualify if:

• age below 18 years
• exacerbation in the past 6 weeks
• inhaled corticosteroid therapy at least 6 weeks prior to study enrollment
• significant co-morbidities

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw 02-097

Warsaw, 02-097, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

induced sputum, BALF, bronchial mucosa samples, exhaled breath condensate, serum

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 21, 2014
• Study Start: September 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 27, 2016

Record last verified: 2014-02

Locations

PL (1)