Airway Inflammation and Remodeling in Asthma and COPD.

Relationship Between Airway Inflammation and Remodeling in Asthma and COPD Patients.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02069054

Enrollment

Registered

2014-02-21

Start date

2012-09-30

Completion date

2015-08-31

Last updated

2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, COPD

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Poland

Outcome results