The Role of Tuberculosis in COPDTROTICNCT02759848
The Role of Tuberculosis in Chronic Obstructive Lung Disease
An observational study of The Role of Tuberculosis in COPD, run by Istanbul Medeniyet University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Role of Tuberculosis in COPD
- How many people
- 598 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients hospitalized with COPD exacerbation (tertiary care clinic)
Who may be able to join
- Being diagnosed with COPD exacerbations
Who cannot join
- Not diagnosed with COPD exacerbations
About this study
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.
Read the 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.
- Conditions
- The Role of Tuberculosis in COPD
- Keywords
- COPD, tuberculosis, mortality
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| with history of TB | Not described | |
| without history of TB | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Role of Tuberculosis in COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil İbrahim Yakar, Istanbul Medeniyet University
- Investigators
- Halil I Yakar, Md, Principal investigator, Halil Ibrahim Yakar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759848
- Sponsor's protocol ID
- TROTIC-1234-TROTIC
- Acronym
- TROTIC
- Status last verified
- May 2016
- First submitted
- 1 May 2016
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Tuberculosis in Chronic Obstructive Lung Disease
- ClinicalTrials.gov ID
- NCT02759848
- Acronym / sponsor ID
- TROTIC / TROTIC-1234-TROTIC
- Conditions
- The Role of Tuberculosis in COPD
- Keywords
- COPD, tuberculosis, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with history of TB | – | – |
| without history of TB | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized with COPD exacerbation (tertiary care clinic)
Key inclusion criteria (1 listed)
- Being diagnosed with COPD exacerbations
Key exclusion criteria (1 listed)
- Not diagnosed with COPD exacerbations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all cause mortality
Time frame: three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halil I Yakar, Md principal investigator
Halil Ibrahim Yakar
Questions about this trial
What is this clinical trial studying?
An observational study of The Role of Tuberculosis in COPD, run by Istanbul Medeniyet University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.