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Completed

NCT Number: NCT06040931

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of medicine Mansoura university

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchoscopy

Procedure

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

Other 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

Primary outcomes

  1. Correlation between neutrophilic airway inflammation and stable COPD patients

    Time frame: one year

    Concentration of neutrophilic count (cell/ml)in BAL

  2. Correlation between frequency of acute exacerbation and stable COPD patients

    Time frame: One year

    Rate of exacerbation / year

Sponsors and collaborators

Lead sponsor

Mansoura University Hospital

Other

Collaborators

  • Ahmed Elsayed Mansour
  • Ahmed Mohamed Fouda
  • Azza Tarik Eliwa
  • Taha Taha Abdelgawad

Registry information

Official study title

Relationship Between Airway Inflammation, Small Airways Dysfunction, and Frequency of Acute Exacerbations in Patients With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 18, 2023
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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