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

NCT ID: NCT06040931

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-06-01

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.

Conditions

COPD Exacerbation Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Infrequent exacerbators (IFE) group

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

Group Type: ACTIVE_COMPARATOR

Bronchoscopy

Intervention Type: PROCEDURE

Bronchoscopy and broncho-alveolar lavage (BAL) to assess neutrophilic count in BAL as a measurement of airway inflammation

Frequent exacerbators (FE) group

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

Group Type: ACTIVE_COMPARATOR

Bronchoscopy

Intervention Type: PROCEDURE

Bronchoscopy and broncho-alveolar lavage (BAL) to assess neutrophilic count in BAL as a measurement of airway inflammation

Interventions

Bronchoscopy

Bronchoscopy and broncho-alveolar lavage (BAL) to assess neutrophilic count in BAL as a measurement of airway inflammation

Intervention Type: PROCEDURE

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azza Tarik Eliwa

UNKNOWN

Sponsor Role: collaborator

Ahmed Elsayed Mansour

UNKNOWN

Sponsor Role: collaborator

Taha Taha Abdelgawad

UNKNOWN

Sponsor Role: collaborator

Ahmed Mohamed Fouda

UNKNOWN

Sponsor Role: collaborator

Mansoura University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abd Elmoniem Mohamed

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed AbdElmoniem, lecturer

Role: PRINCIPAL_INVESTIGATOR

Mansoura university Faculty of medicine

Locations

faculty of medicine Mansoura university

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

M.S.21.08.1628

Identifier Type: -

Identifier Source: org_study_id