Atopy and Frequency of Exacerbation in Chronic Obstructive Pulmonary Disease Patients

NCT06518473 | Recruiting DMC

• 1 other identifier: R.24.06.2680
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

atopy; frequency of exacerbation; chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (2)

• Atopy in chronic obstructive pulmonary disease patients

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

  6 months

• Chronic obstructive pulmonary disease patients

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

  2 months

Study Arms (1)

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

Diagnostic Test: Skin prick test

Interventions

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)

Also known as: Total IgE

Chronic obstructive pulmonary disease patients

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Mohamed AbdElmoniem, lecturer

  Lecturer of chest medicine Faculty of medicine Mansoura university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed AbdElmoniem, lecturer

CONTACT

01014008473; dr.m1993@mans.edu.eg

Taha Abdelgawad, Professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of chest medicine

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 24, 2024
• Study Start: July 14, 2024
• Primary Completion: September 15, 2025
• Study Completion: December 15, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

EG (1)