NCT04711629

Brief Summary

Smoking is the most important factor in the etiology of COPD. Some of the patients with COPD continue to smoke despite knowing this situation or they cannot quit even if they want. The aim of this study is; To examine patients with COPD who continue to smoke in terms of perception of dyspnea, exercise capacity, psychological symptoms and quality of life.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

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

November 5, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

Same day

First QC Date

November 5, 2020

Last Update Submit

January 13, 2021

Conditions

CopdSmoking

Keywords

copdsmoking

Outcome Measures

Primary Outcomes (1)

  • Exercise Capacity

    Six minutes walk test

    6 minutes

Secondary Outcomes (6)

  • Respiratory Functions

    30 minutes

  • Dyspnea Sensation

    20 minutes

  • Disease Specific Quality of Life

    20 minutes

  • Anxiety

    20 minutes

  • Depression

    20 minutes

  • +1 more secondary outcomes

Study Arms (2)

Smoker COPD

EXPERIMENTAL

Patients who continue to smoke

Other: Clinical Tests

Ex-smoker COPD

ACTIVE COMPARATOR

Patients who quit smoking.

Other: Clinical Tests

Interventions

Clinical TestsOTHER

Respiratory function test, arterial blood gas analysis, six-minute walking test (6-MWT), mMRC Dyspnea Scale, St George Quality of Life Questionnaire and Hospital Anxiety Depression Scale

Ex-smoker COPDSmoker COPD

Eligibility Criteria

Age18 Years - 90 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoker COPD Patients who smoker

You may not qualify if:

  • Not volunteer to participate the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSmoking

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Smoker COPD Ex Smoker COPD
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

November 5, 2020

First Posted

January 15, 2021

Study Start

January 1, 2021

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share