Serum Surfactant Protein-D as Predictor of Disease Severity in Hospitalized COPD Patients

NCT ID: NCT07154953

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-01-01

Brief 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

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Serum Surfactant Protein-D

Intervention Type: DIAGNOSTIC_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

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 .

Serum Surfactant Protein-D

Intervention Type: DIAGNOSTIC_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

Interventions

Serum Surfactant Protein-D

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Adults ≥40 years diagnosed with COPD based on prior diagnosis or spirometry if available.
• Admission for acute exacerbation (AECOPD) in ward or Respiratory ICU.

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Mostafa Ahmed Mohamed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heba Ahmed Abdelhafeez, Professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

HA Abdelhafeez, Professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Asmaa Mostafa Ahmed

Role: CONTACT

smsm66023@gmail.com

01113907062

Heba Ahmed Abdelhafeez, Professor

Role: CONTACT

Heb.abdelhafeez@anu.edu.eg

01006268407

References

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.

Reference Type: BACKGROUND

PMID: 28610627 (View on PubMed)

He 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.

Reference Type: BACKGROUND

PMID: 40028331 (View on PubMed)

Other Identifiers

SP-D in COPD

Identifier Type: -

Identifier Source: org_study_id