Airway Inflammation and Remodeling in Asthma and COPD.

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069054
• Other study ID #: IPU-DIMPA-WUM13(2)
• Status: Completed
• Phase: N/A
• First received: February 19, 2014
• Last updated: April 26, 2016
• Start date: September 2012
• Est. completion date: August 2015

Study information

• Verified date: February 2014
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• COPD
• Inflammation

Locations

Country	Name	City	State
Poland	Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw 02-097	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	Yes