Airway Inflammation and Remodeling in Asthma and COPD.

April 26, 2016 updated by: Medical University of Warsaw

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Healthy subjects
Asthma
Patients with mild to moderate asthma diagnosed in accordance with GINA
COPD
Patients with mild to moderate COPD diagnosed in accordance with GOLD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 1-2 months after completion of study procedures (bronchoscopy, induced sputum, etc.) in all patients (probably January 2015)
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
Approximately 1-2 months after completion of study procedures (bronchoscopy with EBUS, HRCT) in all patients (probably January 2015)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 21, 2014

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPU-DIMPA-WUM13(2)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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