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OpenTrials
Completed

NCT Number: NCT02069054

Airway Inflammation and Remodeling in Asthma and COPD.

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Warsaw, 02-097, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Inflammatory markers

    Time frame: 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.

  2. Airway wall thickness

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 21, 2014
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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