Assessment of Trace Elements, Systemic Inflammation and Electrolytes

NCT05718453 | Completed Phase 1 DMC

• 1 other identifier: Rasha Abdelfattah
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

COPD is one of the most common causes of health problems worldwide. It is a disease that is associated with several systemic features that affect its morbidity and mortality.

Conditions

Copd

Keywords

COPD; Biomarkers; Trace elements; Electrolytes

Outcome Measures

Primary Outcomes (2)

• Assessment of the pain resulted in COPD

  The Pain was measured by using the visual analogue score (VAS) as Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain

  from baseline to 72 hours

• Number of participants with abnormal laboratory test results

  he study tried to assess some Laboratory Tests in blood and comparing the level of their results in patients with stable and patients with exacerbation of theirs disease and aslo comparing their values between patients who needed and those who did not need mechanical ventilation

  from baseline to 48 hours after the taking blood samle

Study Arms (3)

COPD patients

ACTIVE COMPARATOR

It is about 60 patients with Stable COPD

Combination Product: Laboratory Tests

Acute exacerbation COPD

ACTIVE COMPARATOR

It is about 40 patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).

Combination Product: Laboratory Tests

healthy controls

PLACEBO COMPARATOR

It is about 40 healthy controls were included in the study

Combination Product: Laboratory Tests

Interventions

Laboratory Tests COMBINATION_PRODUCT

Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.

Acute exacerbation COPD; COPD patients; healthy controls

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• COPD patients

You may not qualify if:

• Patients with Cardiovascular diseases,
• diabetes mellitus,
• chronic kidney disease,
• chronic liver disease,
• collagen vascular diseases,
• cancer,
• currently smoking,
• current pneumonia or inflammation, or refused to participate in the study

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Minia university

Minya, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Mohammad O Abdel Aziz, Professor

  Department of Internal medicine Minia university, Minia, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: February 8, 2023
• Study Start: June 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 15, 2019
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)