COPD, Asthma,ACONCT04056364
Diagnostic Value of Sputum Cytology in Asthma-COPD Overlap
An observational study of COPD, Asthma,ACO, run by Assiut University.
Trial summary
The aim of this study is to evaluate the diagnostic value of sputum cell counts in differentiation between asthma, COPD and ACO. to examine the relationship between sputum cell counts in bronchial revers¬ibility and bronchial hyperresponsiveness Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COPD, Asthma,ACO
- What is being tested?
- sputum cytology
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Oct 2021
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: all patients known have Asthma, COPD, ACO . age from 18 years until 75
Who may be able to join
- all patients known to be Asthma, COPD, ACO
Who cannot join
- Patients will be excluded if they have confounding pulmonary comorbidities, such as pulmonary tuberculosis, interstitial lung disease, lung cancer or pulmonary infection, and had a cognitive impairment that may affect the collaboration or comprehension of the study.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to evaluate the diagnostic value of sputum cell counts in differentiation between asthma, COPD and ACO.
to examine the relationship between sputum cell counts in bronchial revers¬ibility and bronchial hyperresponsiveness
Read the detailed description
Asthma and COPD are considered as chronic airway inflammatory diseases, which are typically associated with Th2-mediated immune response in asthma and related to the characteristics of Th1-mediated immunity in COPD . Asthma-COPD overlap (ACO) is the term to describe patients who have features of both asthma and COPD, recom¬mended by the 2019 Global Initiative for Asthma (GINA) and the Global Initiative for Chronic Obstruction Lung Disease (GOLD) guidelines. Patients with asthma and COPD are commonly seen in clinical practice. In addition, compared with patients with asthma or COPD alone, patients with ACO experience frequent exacerbations and hospitalizations, have poor quality of life, a more rapid decline in lung function and high mortality, and consume a disproportionate amount of health care resources than asthma or COPD alone .
Cell count in induced sputum is a noninvasive biomarker to assess airway inflammation phenotypes. Accordingly, sputum cell counts are extensively used in the treatment of asthma and COPD. Nevertheless, the clinical application of sputum cell counts in patients with asthma-COPD overlap (ACO) remains elusive .
- Conditions
- COPD, Asthma,ACO
- Being tested
- sputum cytology
- 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.
sputum cytologyBiological
Sputum cytology refers to the examination of sputum (mucus) under a microscope to look for abnormal or cancerous cells. Sputum, or phlegm, is the fluid that is secreted by cells in the lower respiratory tract such as the bronchi and the trachea. It differs from saliva, in that it contains cells that line the respiratory passages.
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Asthma patients will be diagnosed according to a clinical history of wheezing, cough, chest tightness or shortness of breath, as well as the presence of BHR (cumulative dose caus¬ing a 20% decrease in FEV1), based on the GINA guidelines. None of them had a history of COPD, or previous doctor-diagnosed ACO. All subjects had not used any oral or/and inhaled corticosteroid (ICS) in the previous 12 weeks. The included patients with asthma had initial diagnosis and were under uncontrolled stage. Receives: Biological: sputum cytology | |
| COPD | COPD patients were diagnosed according to the GOLD criterion, which included a post-bronchodilator spirometry to confirm airflow obstruction (FEV1 to forced vital capacity ratio [FEV1/FVC] ,70%), in a clinical context (dyspnea, chronic cough or sputum production, and a history of expo¬sure to risk factors for the disease). They had received a COPD diagnosis at least 1 year before the study. None of them had a history of asthma. All subjects had not used any oral or/and ICS in the previous 4 weeks. The included COPD patients had exacerbations. The GOLD stage of COPD was defined according to the 2019 recommendations of GOLD. Receives: Biological: sputum cytology | |
| ACO | ACO will be diagnosed by two steps: the first step is the identification of a history of chronic airway disease, i.e., chronic or recurrent cough, sputum production, wheezing, or repeated acute lower respiratory tract infections. In the second step, the features of asthma and those of COPD that best describe the patients Receives: Biological: sputum cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of sputum cytology in Asthma , COPD, ACO
A differential cell count will be obtained from 400 cells under 400× microscope to identify the severity and type of airway inflammation in all patients. Squamous cell count less than 10% in each sample will be deemed adequate for further analysis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD, Asthma,ACOStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Memo Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056364
- Sponsor's protocol ID
- sputum cytology
- Status last verified
- Aug 2019
- First submitted
- 12 Aug 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ojanguren I, Moullec G, Hobeika J, Miravitlles M, Lemiere C. Clinical and inflammatory characteristics of Asthma-COPD overlap in workers with occupational asthma. PLoS One. 2018 Mar 2;13(3):e0193144. doi: 10.1371/journal.pone.0193144. eCollection 2018.
PubMed 29499062
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Sputum Cytology in Asthma-COPD Overlap
- ClinicalTrials.gov ID
- NCT04056364
- Acronym / sponsor ID
- sputum cytology
- Conditions
- COPD, Asthma,ACO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 14 Aug 2019 (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.
The aim of this study is to evaluate the diagnostic value of sputum cell counts in differentiation between asthma, COPD and ACO.
to examine the relationship between sputum cell counts in bronchial revers¬ibility and bronchial hyperresponsiveness
Detailed description
Asthma and COPD are considered as chronic airway inflammatory diseases, which are typically associated with Th2-mediated immune response in asthma and related to the characteristics of Th1-mediated immunity in COPD . Asthma-COPD overlap (ACO) is the term to describe patients who have features of both asthma and COPD, recom¬mended by the 2019 Global Initiative for Asthma (GINA) and the Global Initiative for Chronic Obstruction Lung Disease (GOLD) guidelines. Patients with asthma and COPD are commonly seen in clinical practice. In addition, compared with patients with asthma or COPD alone, patients with ACO experience frequent exacerbations and hospitalizations, have poor quality of life, a more rapid decline in lung function and high mortality, and consume a disproportionate amount of health care resources than asthma or COPD alone .
Cell count in induced sputum is a noninvasive biomarker to assess airway inflammation phenotypes. Accordingly, sputum cell counts are extensively used in the treatment of asthma and COPD. Nevertheless, the clinical application of sputum cell counts in patients with asthma-COPD overlap (ACO) remains elusive .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Biological: sputum cytologyAsthma patients will be diagnosed according to a clinical history of wheezing, cough, chest tightness or shortness of breath, as well as the presence of BHR (cumulative dose caus¬ing a 20% decrease in FEV1), based on the GINA guidelines. None of them had a history of COPD, or previous doctor-diagnosed ACO. All subjects had not used any oral or/and inhaled corticosteroid (ICS) in the previous 12 weeks. The included patients with asthma had initial diagnosis and were under uncontrolled stage. |
| COPD | – | Biological: sputum cytologyCOPD patients were diagnosed according to the GOLD criterion, which included a post-bronchodilator spirometry to confirm airflow obstruction (FEV1 to forced vital capacity ratio [FEV1/FVC] ,70%), in a clinical context (dyspnea, chronic cough or sputum production, and a history of expo¬sure to risk factors for the disease). They had received a COPD diagnosis at least 1 year before the study. None of them had a history of asthma. All subjects had not used any oral or/and ICS in the previous 4 weeks. The included COPD patients had exacerbations. The GOLD stage of COPD was defined according to the 2019 recommendations of GOLD. |
| ACO | – | Biological: sputum cytologyACO will be diagnosed by two steps: the first step is the identification of a history of chronic airway disease, i.e., chronic or recurrent cough, sputum production, wheezing, or repeated acute lower respiratory tract infections. In the second step, the features of asthma and those of COPD that best describe the patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patients known have Asthma, COPD, ACO . age from 18 years until 75
Key inclusion criteria (1 listed)
- all patients known to be Asthma, COPD, ACO
Key exclusion criteria (1 listed)
- Patients will be excluded if they have confounding pulmonary comorbidities, such as pulmonary tuberculosis, interstitial lung disease, lung cancer or pulmonary infection, and had a cognitive impairment that may affect the collaboration or comprehension of the study.
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 |
|---|---|---|
| sputum cytologySputum cytology refers to the examination of sputum (mucus) under a microscope to look for abnormal or cancerous cells. Sputum, or phlegm, is the fluid that is secreted by cells in the lower respiratory tract such as the bronchi and the trachea. It differs from saliva, in that it contains cells that line the respiratory passages. | Biological | ACO, Asthma, COPD |
Primary outcome
comparison of sputum cytology in Asthma , COPD, ACO
Time frame: Baseline
A differential cell count will be obtained from 400 cells under 400× microscope to identify the severity and type of airway inflammation in all patients. Squamous cell count less than 10% in each sample will be deemed adequate for further analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Background: PubMed 29499062Ojanguren I, Moullec G, Hobeika J, Miravitlles M, Lemiere C. Clinical and inflammatory characteristics of Asthma-COPD overlap in workers with occupational asthma. PLoS One. 2018 Mar 2;13(3):e0193144. doi: 10.1371/journal.pone.0193144. eCollection 2018.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, Asthma,ACO, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hesham Memo, resident (01094813767, hesham.memo1117@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of sputum cytology in Asthma , COPD, ACO (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04056364, which also lists 1 linked publication.
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 20 Sep 2019.