Clinical trial NCT06518473: Atopy and Frequency of Exacerbation in Chronic Obstructive Pulmonary Disease Patients
Official title: The Relation Between Atopy and Frequency of Exacerbation in Chronic Obstructive Pulmonary Disease Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: atopy
frequency of exacerbation
chronic obstructive pulmonary disease
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 40-70 years diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 criteria

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) is a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production and/or exacerbations) due to abnormalities of airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction.

The presence of non-fully reversible airflow obstruction (FEV1/FVC \< 0.7 post-bronchodilation) measured by spirometry confirms the diagnosis of COPD

Detailed description: Chronic Obstructive Pulmonary Disease(COPD) is a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production and/or exacerbations) due to abnormalities of airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction.

The presence of non-fully reversible airflow obstruction (FEV1/FVC \< 0.7 post-bronchodilation) measured by spirometry confirms the diagnosis of COPD Inflammation of the bronchial wall is characterized by the presence of neutrophils and macrophages and by increased concentrations of IL-8 and Th1 cytokines, as well as by a proteinase /antiproteinase imbalance, and this could explain the poorer response to inhaled corticosteroids (ICs) seen in COPD.

Asthma may also be a risk factor for the development of chronic airflow obstruction and COPD and Epidemiological Study of Airway Obstructive Disease, adults diagnosed of asthma were found to have a 12-fold higher risk of acquiring COPD over time compared to those without asthma, after adjusting for smoking.

Although both COPD and asthma are associated with chronic inflammation of the respiratory tract, there are differences in the inflammatory cells and mediators involved in the two diseases, some patients with COPD have an inflammatory pattern with increased eosinophils cells, similar to that of asthma.

When there is diagnostic of Asthma and COPD overlap (ACO) uncertainty, an elevated total serum immunoglobulin E (IgE; \>100 international units/mL), elevated peripheral blood eosinophil count (\>300 cells/microL), and evidence of allergic disease (eg, skin testing or immunoassays for perennial allergen sensitivity) may point a clinician to asthma or Asthma - COPD overlap (ACO). Elevated sputum eosinophil counts, if available, are more common in asthma or ACO than COPD The Dutch hypothesis suggests that atopy and bronchial hyper-responsiveness , which are important markers of asthma, can be involved in the pathogenesis of COPD, although there is no clear evidence regarding the frequency of atopy (including asthma), Allergic rhinitis (AR), eczema, or increased IgE levels in patients with COPD, because most studies have involved small samples and limited evaluation of atopy.

Eligibility criteria: Inclusion Criteria:

* Adults aged 40-70 years diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 criteria

Exclusion Criteria:

* Patients with known allergic diseases before enrollment
* Patients with associated other chronic respiratory disorders
* Patients with significant comorbidities that could influence respiratory function.
* Recent respiratory infections or use of systemic corticosteroids within the last month before enrollment.

Primary outcomes:
measure: Atopy in chronic obstructive pulmonary disease patients
timeFrame: 6 months
measure: Chronic obstructive pulmonary disease patients
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mohamed AbdElmoniem
Study officials:
affiliation: Lecturer of chest medicine Faculty of medicine Mansoura university
name: Mohamed AbdElmoniem, lecturer
role: PRINCIPAL_INVESTIGATOR
References: