COPDNCT07154953
Serum Surfactant Protein-D as Predictor of Disease Severity in Hospitalized COPD Patients
An observational study of COPD, run by Assiut University.
Trial summary
evaluation of the serum levels of surfactant protein-D (SP-D), C-reactive protein (CRP), fibrinogen, and peripheral blood neutrophilic and eosinophilic counts in patients with COPD correlation of these biomarkers with clinical, functional, and radiological parameters Read more about this study
- Who is it for?
- Ages 40 to 88 years
- Conditions the study is for
- COPD
- What is being tested?
- Serum Surfactant Protein-D
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 88 years
- All sexes
- Adult, Older adult
Study population: Adults ≥40 years diagnosed with COPD based on prior diagnosis or spirometry if available. Admission for acute exacerbation (AECOPD) in ward or Respiratory ICU.
Who may be able to join
- Adults ≥40 years diagnosed with COPD based on prior diagnosis or spirometry if available.
- Admission for acute exacerbation (AECOPD) in ward or Respiratory ICU.
Who cannot join
- Active pulmonary infection unrelated to COPD (e.g. tuberculosis, fungal infections)
- Other chronic lung diseases such as asthma, interstitial lung disease, or lung cancer
- Use of systemic corticosteroids for conditions other than COPD exacerbation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Serum Surfactant Protein-D and Inflammatory Biomarkers as Predictors of Disease Severity in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients
evaluation of the serum levels of surfactant protein-D (SP-D), C-reactive protein (CRP), fibrinogen, and peripheral blood neutrophilic and eosinophilic counts in patients with COPD correlation of these biomarkers with clinical, functional, and radiological parameters
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a chronic progressive inflammatory disease of the airways and lungs, mainly caused by cigarette smoking and environmental exposures .It is characterized by airflow limitation that is not fully reversible, with exacerbations and systemic manifestations.
In COPD, there is a significant immune dysregulation, involving both innate and adaptive immune responses.Surfactant Protein D (SP-D) is a lung-specific collectin, produced primarily by alveolar type II cells and Clara cells.SP-D plays a key role in the innate immune defense of the lungs, particularly in modulating inflammation, enhancing phagocytosis, and neutralizing pathogens.
In COPD, the epithelial barrier is compromised, leading to increased leakage of SP-D from the lungs into the bloodstream.As a result, serum levels of SP-D are elevated in COPD patients, and this elevation is positively associated with disease severity and exacerbation frequency.
.SP-D has been proposed as a non-invasive biomarker for COPD severity, progression, and response to therapy.Several studies support the use of SP-D as a marker of systemic inflammation and lung tissue damage in COPD.Measuring serum SP-D could provide a valuable tool for early detection, monitoring progression, and personalizing management of COPD patients.Surfactant protein D (SP D) as a prognostic biomarker needs further studies to validate its clinical applicability.
- Conditions
- COPD
- Being tested
- Serum Surfactant Protein-D
- 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.
Serum Surfactant Protein-DDiagnostic test
Several studies support the use of SP-D as a marker of systemic inflammation and lung tissue damage in COPD.Measuring serum SP-D could provide a valuable tool for early detection, monitoring progression, and personalizing management of COPD patients.Surfactant protein D (SP D) as a prognostic biomarker needs further studies to validate its clinical applicability
| Study group | Role | What they receive |
|---|---|---|
| patients with acute COPD exacerbation admitted to ICU | * Adults ≥40 years diagnosed with COPD based on prior diagnosis or spirometry if available.
* Admission for acute exacerbation (AECOPD) in Respiratory ICU. Receives: Diagnostic Test: Serum Surfactant Protein-D | |
| patients with COPD admitted to ward settings | * Adults ≥40 years diagnosed with COPD based on prior diagnosis or spirometry if available.
* Admission for acute exacerbation (AECOPD) in ward . Receives: Diagnostic Test: Serum Surfactant Protein-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of serum SP-D levels
To evaluate serum SP-D levels in patients with acute COPD exacerbation admitted to ICU and ward settings
Measured: baseline
Secondary outcomes (1)
• Correlation of SP-D with: o Systemic inflammatory markers (CRP, fibrinogen, eosinophils, NLR) o Symptom burden and dyspnea scores (CAT, mMRC) o Prognostic scores (DECAF, APACHE II) o Basic CT chest findings
- Correlate SP-D with:
- Systemic inflammatory markers (CRP, fibrinogen, eosinophils, NLR)
- Symptom burden and dyspnea scores (CAT, mMRC)
- Prognostic scores (DECAF, APACHE II)
- Basic CT chest findings
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mostafa Ahmed Mohamed, Assiut University
- Investigators
- Heba Ahmed Abdelhafeez, Professor, Principal investigator, Assiut UniversityHA Abdelhafeez, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154953
- Sponsor's protocol ID
- SP-D in COPD
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zemans RL, Jacobson S, Keene J, Kechris K, Miller BE, Tal-Singer R, Bowler RP. Multiple biomarkers predict disease severity, progression and mortality in COPD. Respir Res. 2017 Jun 13;18(1):117. doi: 10.1186/s12931-017-0597-7.
PubMed 28610627He X, Ji J, Zheng D, Luo Z, Luo L, Guo L. Serum surfactant protein D as a significant biomarker for predicting occurrence, progression, acute exacerbation, and mortality in interstitial lung disease: a systematic review and meta-analysis. Front Immunol. 2025 Feb 14;16:1450798. doi: 10.3389/fimmu.2025.1450798. eCollection 2025.
PubMed 40028331
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Surfactant Protein-D and Inflammatory Biomarkers as Predictors of Disease Severity in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT07154953
- Acronym / sponsor ID
- SP-D in COPD
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 4 Sep 2025 (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.
evaluation of the serum levels of surfactant protein-D (SP-D), C-reactive protein (CRP), fibrinogen, and peripheral blood neutrophilic and eosinophilic counts in patients with COPD correlation of these biomarkers with clinical, functional, and radiological parameters
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a chronic progressive inflammatory disease of the airways and lungs, mainly caused by cigarette smoking and environmental exposures .It is characterized by airflow limitation that is not fully reversible, with exacerbations and systemic manifestations.
In COPD, there is a significant immune dysregulation, involving both innate and adaptive immune responses.Surfactant Protein D (SP-D) is a lung-specific collectin, produced primarily by alveolar type II cells and Clara cells.SP-D plays a key role in the innate immune defense of the lungs, particularly in modulating inflammation, enhancing phagocytosis, and neutralizing pathogens.
In COPD, the epithelial barrier is compromised, leading to increased leakage of SP-D from the lungs into the bloodstream.As a result, serum levels of SP-D are elevated in COPD patients, and this elevation is positively associated with disease severity and exacerbation frequency.
.SP-D has been proposed as a non-invasive biomarker for COPD severity, progression, and response to therapy.Several studies support the use of SP-D as a marker of systemic inflammation and lung tissue damage in COPD.Measuring serum SP-D could provide a valuable tool for early detection, monitoring progression, and personalizing management of COPD patients.Surfactant protein D (SP D) as a prognostic biomarker needs further studies to validate its clinical applicability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with acute COPD exacerbation admitted to ICU | – | Diagnostic Test: Serum Surfactant Protein-D* Adults ≥40 years diagnosed with COPD based on prior diagnosis or spirometry if available. * Admission for acute exacerbation (AECOPD) in Respiratory ICU. |
| patients with COPD admitted to ward settings | – | Diagnostic Test: Serum Surfactant Protein-D* Adults ≥40 years diagnosed with COPD based on prior diagnosis or spirometry if available. * Admission for acute exacerbation (AECOPD) in ward . |
Who may qualify
- Ages
- 40 to 88 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults ≥40 years diagnosed with COPD based on prior diagnosis or spirometry if available. Admission for acute exacerbation (AECOPD) in ward or Respiratory ICU.
Key inclusion criteria (2 listed)
- Adults ≥40 years diagnosed with COPD based on prior diagnosis or spirometry if available.
- Admission for acute exacerbation (AECOPD) in ward or Respiratory ICU.
Key exclusion criteria (3 listed)
- Active pulmonary infection unrelated to COPD (e.g. tuberculosis, fungal infections)
- Other chronic lung diseases such as asthma, interstitial lung disease, or lung cancer
- Use of systemic corticosteroids for conditions other than COPD exacerbation
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 |
|---|---|---|
| Serum Surfactant Protein-DSeveral studies support the use of SP-D as a marker of systemic inflammation and lung tissue damage in COPD.Measuring serum SP-D could provide a valuable tool for early detection, monitoring progression, and personalizing management of COPD patients.Surfactant protein D (SP D) as a prognostic biomarker needs further studies to validate its clinical applicability | Diagnostic test | patients with COPD admitted to ward settings, patients with acute COPD exacerbation admitted to ICU |
Primary outcome
evaluation of serum SP-D levels
Time frame: baseline
To evaluate serum SP-D levels in patients with acute COPD exacerbation admitted to ICU and ward settings
1 secondary outcome
• Correlation of SP-D with: o Systemic inflammatory markers (CRP, fibrinogen, eosinophils, NLR) o Symptom burden and dyspnea scores (CAT, mMRC) o Prognostic scores (DECAF, APACHE II) o Basic CT chest findings
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Background: PubMed 28610627Zemans RL, Jacobson S, Keene J, Kechris K, Miller BE, Tal-Singer R, Bowler RP. Multiple biomarkers predict disease severity, progression and mortality in COPD. Respir Res. 2017 Jun 13;18(1):117. doi: 10.1186/s12931-017-0597-7.
- Background: PubMed 40028331He X, Ji J, Zheng D, Luo Z, Luo L, Guo L. Serum surfactant protein D as a significant biomarker for predicting occurrence, progression, acute exacerbation, and mortality in interstitial lung disease: a systematic review and meta-analysis. Front Immunol. 2025 Feb 14;16:1450798. doi: 10.3389/fimmu.2025.1450798. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Heba Ahmed Abdelhafeez, Professor principal investigator
Assiut University
HA Abdelhafeez, Professor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, 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 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: opening soon, as of the sponsor's last update on 10 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Mostafa Ahmed (01113907062, smsm66023@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of serum SP-D levels (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 NCT07154953, which also lists 2 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 10 Sep 2025.