NCT05475977

Brief Summary

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.

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Status
unknown

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

June 28, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 2, 2022

Status Verified

August 1, 2022

Enrollment Period

8 months

First QC Date

June 28, 2022

Last Update Submit

August 1, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with criteria of severe COPD

    Criteria of severe COPD include emphysematous bullae, thick bronchial walls.

    18 months

Study Arms (3)

First Group

Thirty patients of COPD smokers patients.

Diagnostic Test: MSCT chest

Second group

Thirty patients of COPD ex-smokers patients.

Diagnostic Test: MSCT chest

Third group

Thirty patients of COPD non-smokers patients.

Diagnostic Test: MSCT chest

Interventions

MSCT chestDIAGNOSTIC_TEST

Multi slice Computed Tomography of the chest

First GroupSecond groupThird group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients with unclear smoking history.
  • Patients with active pneumonia.
  • Patients with acute COPD exacerbation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Somaia Ahmad AbdAllah Ahmad, M.B.B.Ch

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Somaia Ahmad AbdAllah Ahmad, M.B.B.Ch

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Main investigator

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 27, 2022

Study Start

August 1, 2022

Primary Completion

April 1, 2023

Study Completion

July 1, 2023

Last Updated

August 2, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

COPD MSCT criteria smoking status

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
2 years
Access Criteria
Medical researchers