Pulmonary Tuberculosis Sequelae in Patients With COPD

Sponsor
Izmir Katip Celebi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04721080
Collaborator
(none)
150
1
12
12.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Functional Outcome Measurements

Detailed Description

This research is planned as a cross-sectional study. It will start within one week following the approval of the ethics committee and will be completed within one year. The universe of the study is S.B.Ü. Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital consists of patients who apply to Pulmonary Rehabilitation Outpatient Clinic. Participants will consist of two different groups: COPD patients with tuberculosis and COPD patients without tuberculosis. The voluntary principle will be taken into account in participating in the research.

Within the scope of the evaluation; Demographic and clinical information of the people who will participate in the study will be recorded, and Thorax CT and PFT examinations performed within the polyclinic service within the last 1 month will be evaluated. Saint George Respiratory Questionaire (SGRQ), 6-minute walk test (6MWT), Medical Research Council Dyspnea Scale (MRC), COPD assessment test (CAT) will be applied to the patients. Regarding the illness histories, the number of hospitalizations and emergency admissions in the last 1 year will be recorded. Detailed tuberculosis anamneses will also be taken from patients with tuberculosis sequelae.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
150 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Effects of Pulmonary Tuberculosis Sequelae on Functional Outcomes in Patients With COPD
Actual Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
May 1, 2021
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
COPD patients with tuberculous sequelae

COPD patients with tuberculous sequelae

Other: Functional Outcome Measurements
Dyspnea Exercise capacity Quality of life assessment

COPD patients without tuberculosis sequela

COPD patients with tuberculous sequelae

Other: Functional Outcome Measurements
Dyspnea Exercise capacity Quality of life assessment

Outcome Measures

Primary Outcome Measures

  1. Exercise Capacity [6 minutes- baseline]

    Six minutes walk test

Secondary Outcome Measures

  1. Dyspnea Assessment [5 minutes- baseline]

    Medical Research Council Scale(MRC)

  2. COPD Assessment [5 minutes- baseline]

    COPD Assessment Test (CAT

  3. Quality of Life Assessment [20 minutes- baseline]

    St. George Respiratory Questionaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • Being in a COPD attack

  • The patient has additional pulmonary comorbidity such as Lung Ca, bronchiectasis, lung fibrosis.

Contacts and Locations

Locations

Site City State Country Postal Code
1 İlknur Naz Gürşan İzmir Turkey 35620

Sponsors and Collaborators

  • Izmir Katip Celebi University

Investigators

  • Principal Investigator: Hulya Sahin, Izmir Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ilknur Naz, Assoc. Prof, Izmir Katip Celebi University
ClinicalTrials.gov Identifier:
NCT04721080
Other Study ID Numbers:
  • IKC145
First Posted:
Jan 22, 2021
Last Update Posted:
Mar 3, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ilknur Naz, Assoc. Prof, Izmir Katip Celebi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2021