COPDNCT05747235
The Role of Computed Tomography in the Phenotyping of COPD Patients
An observational study of COPD, run by Aswan University at 1 site in Egypt.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable disease that is characterized by respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- CT chest
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 31 Dec 2023
- How long will I take part?
- 1 Year
- 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 80 years
- All sexes
- Adult, Older adult
Study population: • All stable COPD patients that lastly confirmed to have the disease based on spirometry and past clinical history according to GOLD (2022).and able to perform MSCT
Who may be able to join
- All stable COPD patients that lastly confirmed to have the disease based on spirometry and past clinical history according to GOLD (2022).
- Age above 18 years.
Who cannot join
- COPD patients associated with other chest diseases as collapse
- COPD patients associated with consolidation
- COPD patients unable to perform spirometry
Trial locations and contacts
1 site in 1 country.
About this study
Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable disease that is characterized by respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. the CT was used for classification of COPD patients into different phenotypes: phenotype A that has minimal emphysema with or without airway disease, phenotype E that has emphysema without airway disease, and finally phenotype M as a mixed form. The investigators aimed to to identify the phenotypes of COPD using radiologic data obtained by computed tomography. Moreover, this study will be designed to answer the questions about possible correlation between pulmonary function parameters and CT.
- Conditions
- COPD
- Being tested
- CT chest
- 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.
CT chestRadiation
All patients will undergo MSCT chest at both inspiratory and expiratory phases in supine position without any contrast media.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying the different phenotypes of COPD using HRCT
Identifying the different phenotypes of COPD using HRCT. moreover, to identify whether there is a possible correlation between CT phenotypes and FEV1, FVC or FEV1/FVC.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Apr 2022
- Primary completion30 Mar 2023
- Study completion31 Dec 2023
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 COPDStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Galal Sayed, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747235
- Sponsor's protocol ID
- CT in COPD phenotyping
- Status last verified
- Feb 2024
- First submitted
- 17 Feb 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fan L, Xia Y, Guan Y, Zhang TF, Liu SY. Characteristic features of pulmonary function test, CT volume analysis and MR perfusion imaging in COPD patients with different HRCT phenotypes. Clin Respir J. 2014 Jan;8(1):45-54. doi: 10.1111/crj.12033. Epub 2013 Jul 31.
PubMed 23711228
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Computed Tomography in the Phenotyping of COPD Patients
- ClinicalTrials.gov ID
- NCT05747235
- Acronym / sponsor ID
- CT in COPD phenotyping
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Feb 2023 (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 common, preventable, and treatable disease that is characterized by respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. the CT was used for classification of COPD patients into different phenotypes: phenotype A that has minimal emphysema with or without airway disease, phenotype E that has emphysema without airway disease, and finally phenotype M as a mixed form. The investigators aimed to to identify the phenotypes of COPD using radiologic data obtained by computed tomography. Moreover, this study will be designed to answer the questions about possible correlation between pulmonary function parameters and CT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- • All stable COPD patients that lastly confirmed to have the disease based on spirometry and past clinical history according to GOLD (2022).and able to perform MSCT
Key inclusion criteria (2 listed)
- All stable COPD patients that lastly confirmed to have the disease based on spirometry and past clinical history according to GOLD (2022).
- Age above 18 years.
Key exclusion criteria (3 listed)
- COPD patients associated with other chest diseases as collapse
- COPD patients associated with consolidation
- COPD patients unable to perform spirometry
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 |
|---|---|---|
| CT chestAll patients will undergo MSCT chest at both inspiratory and expiratory phases in supine position without any contrast media. | Radiation | – |
Primary outcome
Identifying the different phenotypes of COPD using HRCT
Time frame: one month
Identifying the different phenotypes of COPD using HRCT. moreover, to identify whether there is a possible correlation between CT phenotypes and FEV1, FVC or FEV1/FVC.
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 2 Feb 2024.
- Background: PubMed 23711228Fan L, Xia Y, Guan Y, Zhang TF, Liu SY. Characteristic features of pulmonary function test, CT volume analysis and MR perfusion imaging in COPD patients with different HRCT phenotypes. Clin Respir J. 2014 Jan;8(1):45-54. doi: 10.1111/crj.12033. Epub 2013 Jul 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COPD, run by Aswan University 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 2 inclusion and 3 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 2 Feb 2024. 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?
Identifying the different phenotypes of COPD using HRCT (time frame: one month). 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 NCT05747235, 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 2 Feb 2024.