Atopy and Frequency of Exacerbation in Chronic Obstructive Pulmonary Disease Patients

NCT ID: NCT06518473

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-14
• Study Completion Date: 2025-12-15

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic obstructive pulmonary disease patients

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

Skin prick test

Intervention Type: DIAGNOSTIC_TEST

Skin Prick Test (SPT): Common allergens including pollen, dust mites, Pet dander and mold.

Serum IgE Levels: Total IgE Peripheral blood eosinophil was defined as an eosinophil count ≥ 5%, Quality of Life Assessment: COPD Assessment Test (CAT)

Interventions

Skin prick test

Skin Prick Test (SPT): Common allergens including pollen, dust mites, Pet dander and mold.

Serum IgE Levels: Total IgE Peripheral blood eosinophil was defined as an eosinophil count ≥ 5%, Quality of Life Assessment: COPD Assessment Test (CAT)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Total IgE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abd Elmoniem Mohamed

Lecturer of chest medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed AbdElmoniem, lecturer

Role: PRINCIPAL_INVESTIGATOR

Lecturer of chest medicine Faculty of medicine Mansoura university

Locations

Mohamed AbdElmoniem

Al Mansurah, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed AbdElmoniem, lecturer

Role: CONTACT

dr.m1993@mans.edu.eg

01014008473

Taha Abdelgawad, Professor

Role: CONTACT

Facility Contacts

Mohamed AbdElmoniem

Role: primary

dr.m1993@mans.edu.eg

01014008473

Taha Abdelgawad

Role: backup

Other Identifiers

R.24.06.2680

Identifier Type: -

Identifier Source: org_study_id