NCT04721080

Brief Summary

It is known that there is a complex relationship between tuberculosis and COPD. Post-tuberculosis airway disease or COPD associated with tuberculosis occurs in a significant portion of tuberculosis patients. However, it was observed that mortality rates and exacerbation rates of COPD patients with tuberculosis sequel were higher. However, the effect of tuberculosis sequela on functional outcomes in COPD patients has not been investigated in the studies. The aim of this study is to determine whether the previous tuberculosis sequelae has a functional effect on patients with COPD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 19, 2021

Last Update Submit

February 27, 2021

Conditions

Keywords

copdtuberculosisexercise capacityquality of life

Outcome Measures

Primary Outcomes (1)

  • Exercise Capacity

    Six minutes walk test

    6 minutes- baseline

Secondary Outcomes (3)

  • Dyspnea Assessment

    5 minutes- baseline

  • COPD Assessment

    5 minutes- baseline

  • Quality of Life Assessment

    20 minutes- baseline

Study Arms (2)

COPD patients with tuberculous sequelae

COPD patients with tuberculous sequelae

Other: Functional Outcome Measurements

COPD patients without tuberculosis sequela

COPD patients with tuberculous sequelae

Other: Functional Outcome Measurements

Interventions

Dyspnea Exercise capacity Quality of life assessment

COPD patients with tuberculous sequelaeCOPD patients without tuberculosis sequela

Eligibility Criteria

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

COPD patients with tuberculous sequelae and COPD patients without tuberculosis sequela

You may qualify if:

  • Volunteering to participate in the study
  • Being over 18 years old
  • Having thorax CT in the last 1 month
  • Having PFT examination performed in the last 1 month

You may not qualify if:

  • Being in a COPD attack
  • The patient has additional pulmonary comorbidity such as Lung Ca, bronchiectasis, lung fibrosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İlknur Naz Gürşan

Izmir, 35620, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveTuberculosis

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Hulya Sahin

    Izmir Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

İlknur N Gürşan, Assoc Prof

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 22, 2021

Study Start

May 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

March 3, 2021

Record last verified: 2021-02

Locations