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

NCT06040931 | Completed

• 1 other identifier: M.S.21.08.1628
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

COPD Exacerbation Acute

Keywords

neutrophilic airway inflammation; small airways dysfunction; acute exacerbation; stable COPD patients

Outcome Measures

Primary Outcomes (2)

• Correlation between neutrophilic airway inflammation and stable COPD patients

  Concentration of neutrophilic count (cell/ml)in BAL

  one year

• Correlation between frequency of acute exacerbation and stable COPD patients

  Rate of exacerbation / year

  One year

Study Arms (2)

Infrequent exacerbators (IFE) group

ACTIVE COMPARATOR

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

Procedure: Bronchoscopy

Frequent exacerbators (FE) group

ACTIVE COMPARATOR

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

Procedure: Bronchoscopy

Interventions

Bronchoscopy PROCEDURE

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

Also known as: 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

Frequent exacerbators (FE) group; Infrequent exacerbators (IFE) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• established diagnosis of COPD according to GOLD 2021
• Patients should quit smoking at least 6 months before enrolment in the study.

You may not qualify if:

• Pulmonary diseases other than COPD e.g parenchymatous lung diseases
• Active smokers.
• Patients unfit for bronchoscopy.
• Immunosuppressive state and immunosuppressive therapy

Sponsors & Collaborators

• Mansoura University Hospital: lead
• Azza Tarik Eliwa: collaborator
• Ahmed Elsayed Mansour: collaborator
• Taha Taha Abdelgawad: collaborator
• Ahmed Mohamed Fouda: collaborator

Study Sites (1)

faculty of medicine Mansoura university

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Mohamed AbdElmoniem, lecturer

  Mansoura university Faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: prospective correlational study

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 18, 2023
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)