Airway Inflammation and Remodeling in Asthma and COPD.

Completed

• Conditions: Asthma; COPD

• Registration Number: NCT02069054
• Lead Sponsor: Medical University of Warsaw

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Status Verified: 2014-02
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-21
• Primary Completion: 2015-05
• Study Completion: 2015-08
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammatory markers	Approximately 1-2 months after completion of study procedures (bronchoscopy, induced sputum, etc.) in all patients (probably January 2015)	Inflammatory markers in exhaled breath condensate and induced sputum in healthy subjects, COPD and asthma patients.
Airway wall thickness	Approximately 1-2 months after completion of study procedures (bronchoscopy with EBUS, HRCT) in all patients (probably January 2015)	Airway wall thickness in healthy subject, COPD and asthma patients assessed by HRCT and EBUS

Trial Locations

Locations (1)

Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw 02-097; 🇵🇱 Warsaw, Poland