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Airway Inflammation, Small Airways Dysfunction, and Frequency of Exacerbations in COPD

Primary Purpose

COPD Exacerbation Acute

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bronchoscopy
Sponsored by
Mansoura University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COPD Exacerbation Acute focused on measuring neutrophilic airway inflammation, small airways dysfunction, acute exacerbation, stable COPD patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: established diagnosis of COPD according to GOLD 2021 Patients should quit smoking at least 6 months before enrolment in the study. Exclusion Criteria: Pulmonary diseases other than COPD e.g parenchymatous lung diseases Active smokers. Patients unfit for bronchoscopy. Immunosuppressive state and immunosuppressive therapy

Sites / Locations

  • faculty of medicine Mansoura university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Infrequent exacerbators (IFE) group

Frequent exacerbators (FE) group

Arm Description

15 patients with infrequent exacerbation (IFE) "≤1 exacerbation per year in the preceding 12 months before enrolment.

15 patients with frequent exacerbation(FE) "≥ 2 per year in the preceding 12 months before enrolment

Outcomes

Primary Outcome Measures

Correlation between neutrophilic airway inflammation and stable COPD patients
Concentration of neutrophilic count (cell/ml)in BAL
Correlation between frequency of acute exacerbation and stable COPD patients
Rate of exacerbation / year

Secondary Outcome Measures

Full Information

First Posted
September 7, 2023
Last Updated
September 14, 2023
Sponsor
Mansoura University Hospital
Collaborators
Azza Tarik Eliwa, Ahmed Elsayed Mansour, Taha Taha Abdelgawad, Ahmed Mohamed Fouda
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1. Study Identification

Unique Protocol Identification Number
NCT06040931
Brief Title
Airway Inflammation, Small Airways Dysfunction, and Frequency of Exacerbations in COPD
Official Title
Relationship Between Airway Inflammation, Small Airways Dysfunction, and Frequency of Acute Exacerbations in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University Hospital
Collaborators
Azza Tarik Eliwa, Ahmed Elsayed Mansour, Taha Taha Abdelgawad, Ahmed Mohamed Fouda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases Chronic Obstructive Pulmonary Disease (COPD) is a heterogenous disease of the lungs that can comprise of different pathophysiological phenotypes, including emphysema, chronic bronchitis, and Small Airways Disease (SAD). COPD is also associated with chronic inflammation and this ongoing inflammation may result in airway remodeling and excessive mucus plugging within the small airways Small airways disease (SAD) is a cardinal feature of chronic obstructive pulmonary disease (COPD) first recognized in the nineteenth century. The diverse histopathological features associated with SAD underpin the heterogeneous nature of COPD. The small airways have been defined as < 2mm diameter and arise from the 4th - 13th generation of airway branching (taking trachea as 1st generation to alveoli as 23rd), but on average arise by the 8th aim of this work is to study the relationship between neutrophilic airway inflammation, small airways dysfunction, and frequency of acute exacerbation in stable COPD patients
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases Chronic Obstructive Pulmonary Disease (COPD) is a heterogenous disease of the lungs that can comprise of different pathophysiological phenotypes, including emphysema, chronic bronchitis, and Small Airways Disease (SAD). COPD is also associated with chronic inflammation and this ongoing inflammation may result in airway remodeling and excessive mucus plugging within the small airways Small airways disease (SAD) is a cardinal feature of chronic obstructive pulmonary disease (COPD) first recognized in the nineteenth century. The diverse histopathological features associated with SAD underpin the heterogeneous nature of COPD. The small airways have been defined as < 2mm diameter and arise from the 4th - 13th generation of airway branching (taking trachea as 1st generation to alveoli as 23rd), but on average arise by the 8th Small airway disease (SAD) has been recognized for many years as a central feature of chronic obstructive pulmonary disease (COPD). Histopathology studies have shown that the narrowing and destruction of small airways in COPD combined with inflammatory cell infiltration in the submucosa increases the severity of the disease. SAD is present in the early stages of COPD and becomes more widespread over time as the disease progresses to more severe COPD Exacerbations are an acute worsening of symptoms resulting in additional therapy and can be classified as mild, moderate, or severe, Exacerbations are associated with faster lung function decline and hospital admissions During both stable periods and exacerbations, there is increased neutrophilic inflammation in the airways of COPD subjects , Neutrophilic inflammation is a common feature of many airway diseases and is associated with disease progression, often irrespective of the initiating cause or underlying diagnosis The aim of this work is to study the relationship between neutrophilic airway inflammation, small airways dysfunction, and frequency of acute exacerbation in stable COPD patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation Acute
Keywords
neutrophilic airway inflammation, small airways dysfunction, acute exacerbation, stable COPD patients

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective correlational study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infrequent exacerbators (IFE) group
Arm Type
Active Comparator
Arm Description
15 patients with infrequent exacerbation (IFE) "≤1 exacerbation per year in the preceding 12 months before enrolment.
Arm Title
Frequent exacerbators (FE) group
Arm Type
Active Comparator
Arm Description
15 patients with frequent exacerbation(FE) "≥ 2 per year in the preceding 12 months before enrolment
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy
Other Intervention Name(s)
body Plethysmography (RV/TLC), Spirometry "pre and post bronchdilator to show poorly reversible airway obstruobstructin, CT-chest (Paired Inspiratory and expiratory HRCT scan) and measuring mean lung density
Intervention Description
Bronchoscopy and broncho-alveolar lavage (BAL) to assess neutrophilic count in BAL as a measurement of airway inflammation
Primary Outcome Measure Information:
Title
Correlation between neutrophilic airway inflammation and stable COPD patients
Description
Concentration of neutrophilic count (cell/ml)in BAL
Time Frame
one year
Title
Correlation between frequency of acute exacerbation and stable COPD patients
Description
Rate of exacerbation / year
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: established diagnosis of COPD according to GOLD 2021 Patients should quit smoking at least 6 months before enrolment in the study. Exclusion Criteria: Pulmonary diseases other than COPD e.g parenchymatous lung diseases Active smokers. Patients unfit for bronchoscopy. Immunosuppressive state and immunosuppressive therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed AbdElmoniem, lecturer
Organizational Affiliation
Mansoura university Faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of medicine Mansoura university
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Airway Inflammation, Small Airways Dysfunction, and Frequency of Exacerbations in COPD

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