Chronic Obstructive Pulmonary DiseaseNCT06684353
Clinical Presentation and Outcome of COPD Patients With Acute Exacerbation Attending Sohag University Hospital
An observational study of Chronic Obstructive Pulmonary Disease, run by Sohag University.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a worldwide public health challenge because of high prevalence and related disability and mortality (1). Acute exacerbation of COPD (AECOPD), defned as the worsening of respiratory symptoms and requirement of additional clinical treatment, it reduces lung function and… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2024to 3 Nov 2025
- 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 90 years
- All sexes
- Adult, Older adult
Study population: patients aged more than 18 years with a confirmed COPD diagnosis according to (GOLD) guidelines, presented with acute exacerbation
Who may be able to join
- patients with a confirmed COPD diagnosis according to (GOLD) guidelines, presented with acute exacerbation
Who cannot join
- Stable COPD
- Any other chronic chest diseases; Bronchial asthma or bronchiectasis
Trial locations and contacts
No sites are listed yet.
Hamdy A Mohammaden, Professor doctor contact
About this study
Chronic obstructive pulmonary disease (COPD) is a worldwide public health challenge because of high prevalence and related disability and mortality (1).
Acute exacerbation of COPD (AECOPD), defned as the worsening of respiratory symptoms and requirement of additional clinical treatment, it reduces lung function and quality of life, and is accompanied by an increased disease-related burden, high hospital mortality and poor outcome (2).
Chronic obstructive pulmonary disease frequently coexists with other chronic diseases, namely comorbidities. They negatively impact prognosis, exacerbations and quality of life in COPD patients. Local and systemic inflammation have been proposed as having a potential role in explaining the association between COPD and these comorbidities (3).
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients in ICU with high risk of mortality (non survivors) | COPD patients on NIV / MV | |
| COPD patients in ICU with low risk of mortality ( survivors ) | COPD patients on NIV / MV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Presentation and Outcome of COPD Patients With Acute Exacerbation Attending Sohag University Hospital
Detection which patient with COPD exacerbation has more risk of survival or mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start30 Nov 2024 (estimated)
- Primary completion3 Nov 2025 (estimated)
- Study completion3 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Abdelaleem Hussien, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684353
- Sponsor's protocol ID
- Soh-Med-24-09-15MS
- Status last verified
- Oct 2024
- First submitted
- 10 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fabbri LM, Boschetto P, Mapp CE; Global Initiative for Chronic Obstructive Lung Disease; Global Initiative for Asthma Management and Prevention. COPD guidelines: the important thing is not to stop questioning. Am J Respir Crit Care Med. 2007 Sep 15;176(6):527-8. doi: 10.1164/rccm.200706-854ED. No abstract available.
PubMed 17823358Bateman ED, Feldman C, O'Brien J, Plit M, Joubert JR; COPD Guideline Working Group of the South African Thoracic Society. Guideline for the management of chronic obstructive pulmonary disease (COPD): 2004 revision. S Afr Med J. 2004 Jul;94(7 Pt 2):559-75.
PubMed 15283307Corrections. Lancet Respir Med. 2017 Oct;5(10):e30. doi: 10.1016/S2213-2600(17)30336-3. Epub 2017 Sep 14. No abstract available.
PubMed 28918970Nakai T, Ueda M, Takeda R. Effects of calcium and magnesium ions on the interaction of corticosterone with rat brain cytosol receptor(s). Endocr Res Commun. 1978;5(2):81-90. doi: 10.3109/07435807809089010.
PubMed 102509Hand D. National Boards lose control of funding. Nurs Stand. 1991 Feb 13-19;5(21):20. No abstract available.
PubMed 1900164
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Presentation and Outcome of COPD Patients With Acute Exacerbation Attending Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06684353
- Acronym / sponsor ID
- Soh-Med-24-09-15MS
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 3 Nov 2025 (estimated)
- Study completion
- 3 Nov 2025 (estimated)
- First posted
- 12 Nov 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 worldwide public health challenge because of high prevalence and related disability and mortality (1).
Acute exacerbation of COPD (AECOPD), defned as the worsening of respiratory symptoms and requirement of additional clinical treatment, it reduces lung function and quality of life, and is accompanied by an increased disease-related burden, high hospital mortality and poor outcome (2).
Chronic obstructive pulmonary disease frequently coexists with other chronic diseases, namely comorbidities. They negatively impact prognosis, exacerbations and quality of life in COPD patients. Local and systemic inflammation have been proposed as having a potential role in explaining the association between COPD and these comorbidities (3).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients in ICU with high risk of mortality (non survivors) | – | –COPD patients on NIV / MV |
| COPD patients in ICU with low risk of mortality ( survivors ) | – | –COPD patients on NIV / MV |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients aged more than 18 years with a confirmed COPD diagnosis according to (GOLD) guidelines, presented with acute exacerbation
Key inclusion criteria (1 listed)
- patients with a confirmed COPD diagnosis according to (GOLD) guidelines, presented with acute exacerbation
Key exclusion criteria (2 listed)
- Stable COPD
- Any other chronic chest diseases; Bronchial asthma or bronchiectasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Presentation and Outcome of COPD Patients With Acute Exacerbation Attending Sohag University Hospital
Time frame: 1 year
Detection which patient with COPD exacerbation has more risk of survival or mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Background: PubMed 17823358Fabbri LM, Boschetto P, Mapp CE; Global Initiative for Chronic Obstructive Lung Disease; Global Initiative for Asthma Management and Prevention. COPD guidelines: the important thing is not to stop questioning. Am J Respir Crit Care Med. 2007 Sep 15;176(6):527-8. doi: 10.1164/rccm.200706-854ED. No abstract available.
- Background: PubMed 15283307Bateman ED, Feldman C, O'Brien J, Plit M, Joubert JR; COPD Guideline Working Group of the South African Thoracic Society. Guideline for the management of chronic obstructive pulmonary disease (COPD): 2004 revision. S Afr Med J. 2004 Jul;94(7 Pt 2):559-75.
- Background: PubMed 28918970Corrections. Lancet Respir Med. 2017 Oct;5(10):e30. doi: 10.1016/S2213-2600(17)30336-3. Epub 2017 Sep 14. No abstract available.
- Background: PubMed 102509Nakai T, Ueda M, Takeda R. Effects of calcium and magnesium ions on the interaction of corticosterone with rat brain cytosol receptor(s). Endocr Res Commun. 1978;5(2):81-90. doi: 10.3109/07435807809089010.
- Background: PubMed 1900164Hand D. National Boards lose control of funding. Nurs Stand. 1991 Feb 13-19;5(21):20. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Hamdy A Mohammaden, Professor doctor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Sohag 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 2 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 15 Nov 2024. 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 Mona A Hussien, Resident doctor (01152232471, mona_abdelaleem_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Presentation and Outcome of COPD Patients With Acute Exacerbation Attending Sohag University Hospital (time frame: 1 year). 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 NCT06684353, which also lists 5 linked publications.
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 15 Nov 2024.