The Role of Tuberculosis in Chronic Obstructive Lung Disease (TROTIC)

Influence of tuberculosis (TB) on natural course of chronic obstructive lung disease (COPD) has not been well known. This study was designed to investigate the effects of history of TB on the long-term course of COPD.

Study Overview

• Status: Completed
• Conditions: The Role of Tuberculosis in COPD

Detailed Description

Patients hospitalized with COPD exacerbation were consecutively included (n=598). Cases were classified into two categories: those with a history of TB and those without. Clinical, demographic, and radiological features were meticulously recorded and patients were followed up for mortality. 93 patients (15%) had past TB. On average, patients with a history of TB were four-year younger (p=0.002). Our study revealed that patients with TB history were diagnosed with COPD five-year earlier and died five-year earlier as compared to the patients without TB. In addition, in the TB history positive group, the rate of hospital admissions per year was higher compared to the group that lacked TB history (2.46±0.26 vs. 1.56±0.88; p=0.001). The patients with TB history had higher PaCO2 and lower FEV1 (p=0.008 and p=0.069 respectively). Median survival was 24 months for patients with past TB, and was 36 months for those without. Kaplan-Meier analysis revealed that although 3-year survival rate was lower in patients with TB history, it was not statistically significant (p=0.08). Cox regression analysis showed that while factors such as age, PaCO2, hematocrit, BMI and the Charlson index affected mortality rates in COPD patients (p<0.05), prior history of TB did not seem to have a significant impact on the mortality.

Our results showed that past TB caused more hospitalizations, lower respiratory functions and higher arterial carbon dioxide levels. It was found that, though the mortality rates were similar, COPD patients with past TB was diagnosed and died five-year earlier. We conclude that history of TB has an important role in natural course of COPD.

• Study Type: Observational
• Enrollment (Actual): 598

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients hospitalized with COPD exacerbation (tertiary care clinic)

Description

Inclusion Criteria:

• Being diagnosed with COPD exacerbations

Exclusion Criteria:

• Not diagnosed with COPD exacerbations

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
with history of TB
without history of TB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all cause mortality	three years

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University
• Investigators: Principal Investigator: Halil I Yakar, Md, Halil Ibrahim Yakar

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 1, 2016
• First Submitted That Met QC Criteria: May 1, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: May 1, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: COPD, tuberculosis, mortality
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Tuberculosis
• Other Study ID Numbers: TROTIC-1234-TROTIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED