Role of MSCT of Chest in Differentiation Between COPD Patients According to Their Smoking Status

Role of Multislice Computed Tomography (MSCT) Chest in Differentiation Between Chronic Obstructive Pulmonary Disease(COPD) Patients According to Their Smoking Status

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality all over the world. Smoking is considered as an important risk factor, but other risk factors are present. Around 30 % of patients with COPD are non-smokers.

Cessation of smoking in patients with COPD causes decreases the presence of micronodules and other criteria of CT chest.

In last few years, some researchers reported that cessation of smoking raise the apparent extent of emphysema. The cause is not obvious, but this paradoxical fall in lung density is thaught to be resulting from decrease in inflammation after smoking cessation.

CT chest criteria of COPD in active smokers, non-smokers and ex-smokers seem to be different.

So, comparison between CT chest Criteria of COPD in smokers, ex-smokers and non-smokers will be searched in this study to detect the role of multislice computed tomography (MSCT) chest in differentiation between COPD patients according to their smoking status.

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Participation
• Intervention / Treatment: Diagnostic test: MSCT chest

Detailed Description

Basic ethical principles of medical research; beneficence (do well), non-maleficence (do no harm), respect and distributive justice were implemented. The study will be carried out in accordance with the Declaration of Helsinki and the principles of good clinical practice.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Somaia Ahmad AbdAllah Ahmad, M.B.B.Ch; Phone Number: 01024833938; Email: somayaahmad64@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COPD patients either smokers, ex-smokers or non-smokers

Description

Inclusion Criteria:

1. All patients with chronic obstructive Pulmonary Disease.
2. Patients above 18 years.

Exclusion Criteria:

1. Patients with unclear smoking history.
2. Patients with active pneumonia.
3. Patients with acute COPD exacerbation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
First Group; Thirty patients of COPD smokers patients.	Diagnostic test: MSCT chest; Multi slice Computed Tomography of the chest
Second group; Thirty patients of COPD ex-smokers patients.	Diagnostic test: MSCT chest; Multi slice Computed Tomography of the chest
Third group; Thirty patients of COPD non-smokers patients.	Diagnostic test: MSCT chest; Multi slice Computed Tomography of the chest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with criteria of severe COPD	Criteria of severe COPD include emphysematous bullae, thick bronchial walls.	18 months

Collaborators and Investigators

• Sponsor: Somaia Ahmad AbdAllah Ahmad
• Investigators: Principal Investigator: Somaia Ahmad AbdAllah Ahmad, M.B.B.Ch, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Somaia Ahmad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: COPD MSCT criteria smoking status
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: Medical researchers
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No