NCT06644456

Brief Summary

This study aimed to show the relationship between CAT Score and airway limitation in smokers who applied to MSKU Chest Diseases Polyclinic with respiratory complaints (shortness of breath, cough, sputum, etc.) and underwent respiratory function tests. CAT Score is a measurement used to evaluate the quality of life of Chronic Obstructive Pulmonary Disease (COPD) patients. CAT Score is a scale used to assess patients' symptoms (such as shortness of breath, cough, and sputum) and problems affecting their daily activities. CAT Score usually takes a value between 0 and 40, and a high score may indicate that the patient's quality of life is low. There are studies on the usability of CAT Score in Bronchiectasis, Tuberculosis, and Asthma Diseases other than COPD. We hypothesize that there is a positive correlation between CAT Score and airway limitation in smokers before COPD develops. The study was planned as cross-sectional. Between July 2024 and December 2024, patients who apply to MSKU Chest Diseases Polyclinic with respiratory complaints and have a history of smoking will have their CAT scores, 6-minute walking test, and height and weight measurements performed and recorded. In our study, the comparison of CAT Scores of individuals who smoke and have normal respiratory function test parameters with those who are not normal but excluded from COPD is planned as the primary endpoint, and comparisons of CAT Scores with exercise capacities and body mass indexes are planned as the secondary endpoint.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 11, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

October 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
Last Updated

March 11, 2026

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

October 11, 2024

Last Update Submit

March 10, 2026

Conditions

Keywords

smokerCAT

Outcome Measures

Primary Outcomes (1)

  • CAT

    In our study, the primary endpoint was to compare the CAT scores of individuals who smoked and had normal pulmonary function test parameters with those who were not normal but excluded from COPD.

    day 1

Secondary Outcomes (1)

  • 6MWT-BMI

    day 1

Study Arms (2)

Smokers with airway limitation

Smokers with FEV1\<80%

Smokers without airway limitation

smokers with FEV1\>80

Eligibility Criteria

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

Patients who applied to MSKU Chest Diseases Polyclinic with respiratory complaints and had a history of smoking were subjected to respiratory function tests.

You may qualify if:

  • Smoking history Being over 18 years old Being symptomatic

You may not qualify if:

  • Having a diagnosis of chronic respiratory disease (COPD, Asthma, IPF)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muğla EAH

Muğla, 48000, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 11, 2024

First Posted

October 16, 2024

Study Start

October 12, 2024

Primary Completion

March 3, 2025

Study Completion

March 10, 2025

Last Updated

March 11, 2026

Record last verified: 2024-11

Locations