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

COPD Exacerbation Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06040931
• Other study ID #: M.S.21.08.1628
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2023
• Source: Mansoura University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD Exacerbation Acute
• Inflammation

Intervention

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

Locations

Country	Name	City	State
Egypt	faculty of medicine Mansoura university	Mansoura

Sponsors (5)

Lead Sponsor	Collaborator
Mansoura University Hospital	Ahmed Elsayed Mansour, Ahmed Mohamed Fouda, Azza Tarik Eliwa, Taha Taha Abdelgawad

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between neutrophilic airway inflammation and stable COPD patients	Concentration of neutrophilic count (cell/ml)in BAL	one year
Primary	Correlation between frequency of acute exacerbation and stable COPD patients	Rate of exacerbation / year	One year