NCT07154953

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Dec 2025Jan 2027

First Submitted

Initial submission to the registry

August 27, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

September 10, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 27, 2025

Last Update Submit

September 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • evaluation of serum SP-D levels

    To evaluate serum SP-D levels in patients with acute COPD exacerbation admitted to ICU and ward settings

    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

    baseline

Study Arms (2)

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.

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 .

Diagnostic Test: Serum Surfactant Protein-D

Interventions

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 settingspatients with acute COPD exacerbation admitted to ICU

Eligibility Criteria

Age40 Years - 88 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 28610627BACKGROUND
  • 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.

    PMID: 40028331BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Heba Ahmed Abdelhafeez, Professor

    Assiut University

    PRINCIPAL INVESTIGATOR
  • HA Abdelhafeez, Professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa Mostafa Ahmed

CONTACT

Heba Ahmed Abdelhafeez, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 4, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

September 10, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share