Pulmonary Tuberculosis Sequelae in Patients With COPD

Effects of Pulmonary Tuberculosis Sequelae on Functional Outcomes in Patients With COPD

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Tuberculosis; Copd
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35620
    • Recruiting
    • İlknur Naz Gürşan
    • Contact: İlknur N Gürşan; Phone Number: 05356954634; Email: ilknurnaz4@gmail.com
    • Principal Investigator: Hulya Sahin, Assoc Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COPD patients with tuberculous sequelae and COPD patients without tuberculosis sequela

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Capacity	Six minutes walk test	6 minutes- baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea Assessment	Medical Research Council Scale(MRC)	5 minutes- baseline
COPD Assessment	COPD Assessment Test (CAT	5 minutes- baseline
Quality of Life Assessment	St. George Respiratory Questionaire	20 minutes- baseline

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University
• Investigators: Principal Investigator: Hulya Sahin, Izmir Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: February 27, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; exercise capacity; tuberculosis; copd
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: IKC145

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No