NCT06684353

Brief 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 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).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

November 30, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2025

Completed
Last Updated

November 15, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

November 10, 2024

Last Update Submit

November 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients aged more than 18 years with a confirmed COPD diagnosis according to (GOLD) guidelines, presented with acute exacerbation

You may qualify if:

  • patients with a confirmed COPD diagnosis according to (GOLD) guidelines, presented with acute exacerbation

You may not qualify if:

  • Stable COPD
  • Any other chronic chest diseases; Bronchial asthma or bronchiectasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 17823358BACKGROUND
  • Bateman 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.

    PMID: 15283307BACKGROUND
  • Corrections. Lancet Respir Med. 2017 Oct;5(10):e30. doi: 10.1016/S2213-2600(17)30336-3. Epub 2017 Sep 14. No abstract available.

    PMID: 28918970BACKGROUND
  • Nakai 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.

    PMID: 102509BACKGROUND
  • Hand D. National Boards lose control of funding. Nurs Stand. 1991 Feb 13-19;5(21):20. No abstract available.

    PMID: 1900164BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mona A Hussien, Resident doctor

CONTACT

Hamdy A Mohammaden, Professor doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at chest department Sohag University Hospital

Study Record Dates

First Submitted

November 10, 2024

First Posted

November 12, 2024

Study Start

November 30, 2024

Primary Completion

November 3, 2025

Study Completion

November 3, 2025

Last Updated

November 15, 2024

Record last verified: 2024-10