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NCT Number: NCT06518473

Atopy and Frequency of Exacerbation in Chronic Obstructive Pulmonary Disease Patients

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

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

Location status: Recruiting

Location contact

Mohamed AbdElmoniem

CONTACT

[email protected]

01014008473

Taha Abdelgawad

CONTACT

Taha Taha Abd El Gawad, Professor

SUB_INVESTIGATOR

Tamer Awad Elsayed, Lecturer

SUB_INVESTIGATOR

About this study

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.

Who can participate

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

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.

Treatment and study plan

Skin prick test

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)

Other names: Total IgE

Primary outcomes

  1. Atopy in chronic obstructive pulmonary disease patients

    Time frame: 6 months

    Total IgE (mg/dl) and ) will be assessed in chronic obstructive pulmonary disease patients

  2. Chronic obstructive pulmonary disease patients

    Time frame: 2 months

    Blood eosinophil count (%) will be assessed in chronic obstructive pulmonary disease patients

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed AbdElmoniem, lecturer

CONTACT

[email protected]

01014008473

Taha Abdelgawad, Professor

CONTACT

Sponsors and collaborators

Lead sponsor

Mansoura University Hospital

Other

Registry information

Official study title

The Relation Between Atopy and Frequency of Exacerbation in Chronic Obstructive Pulmonary Disease Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2024
Registry last updated
Aug 3, 2025

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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