Chronic Obstructive Pulmonary DiseaseNCT06518473
Atopy and Frequency of Exacerbation in Chronic Obstructive Pulmonary Disease Patients
An observational study of Chronic Obstructive Pulmonary Disease, run by Mansoura University Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Skin prick test
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jul 2024to 15 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Adult, Older adult
Study population: Adults aged 40-70 years diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 criteria
Who may be able to join
- Adults aged 40-70 years diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relation Between 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
Read the 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
- Being tested
- Skin prick test
- Keywords
- atopy, frequency of exacerbation, chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin prick testDiagnostic test
Also called Total IgE
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Skin prick test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atopy in chronic obstructive pulmonary disease patients
Total IgE (mg/dl) and ) will be assessed in chronic obstructive pulmonary disease patients
Measured: 6 months
Chronic obstructive pulmonary disease patients
Blood eosinophil count (%) will be assessed in chronic obstructive pulmonary disease patients
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start14 Jul 2024
- Primary completion15 Sep 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd Elmoniem Mohamed, Mansoura University Hospital
- Investigators
- Mohamed AbdElmoniem, lecturer, Principal investigator, Lecturer of chest medicine Faculty of medicine Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518473
- Sponsor's protocol ID
- R.24.06.2680
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Atopy and Frequency of Exacerbation in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT06518473
- Acronym / sponsor ID
- R.24.06.2680
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- atopy, frequency of exacerbation, chronic obstructive pulmonary disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 14 Jul 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic obstructive pulmonary disease patients | – | Diagnostic Test: Skin prick testAdults aged 40-70 years diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 criteria |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults aged 40-70 years diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 criteria
Key inclusion criteria (1 listed)
- Adults aged 40-70 years diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 criteria
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin prick testAlso: Total IgESkin 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) | Diagnostic test | Chronic obstructive pulmonary disease patients |
Primary outcome
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
Chronic obstructive pulmonary disease patients
Time frame: 2 months
Blood eosinophil count (%) will be assessed in chronic obstructive pulmonary disease patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed AbdElmoniem, lecturer principal investigator
Lecturer of chest medicine Faculty of medicine Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Mansoura University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atopy in chronic obstructive pulmonary disease patients (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.