Pulmonary Tuberculosis Sequelae in Patients With COPD

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04721080
• Other study ID #: IKC145
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: February 2021
• Source: Izmir Katip Celebi University
• Contact: Ilknur N Gürsan, Assoc Prof
• Phone: 05356954634
• Email: ilknurnaz4[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Copd
• Quality of Life
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

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

Locations

Country	Name	City	State
Turkey	Ilknur Naz Gürsan	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Capacity	Six minutes walk test	6 minutes- baseline
Secondary	Dyspnea Assessment	Medical Research Council Scale(MRC)	5 minutes- baseline
Secondary	COPD Assessment	COPD Assessment Test (CAT	5 minutes- baseline
Secondary	Quality of Life Assessment	St. George Respiratory Questionaire	20 minutes- baseline