CopdNCT04721080
Pulmonary Tuberculosis Sequelae in Patients With COPD
An observational study of Copd and Tuberculosis, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd, Tuberculosis, Quality of Life
- What is being tested?
- Functional Outcome Measurements
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 1 May 2021
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients with tuberculous sequelae and COPD patients without tuberculosis sequela
Who may be able to join
- 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
Who cannot join
- Being in a COPD attack
- The patient has additional pulmonary comorbidity such as Lung Ca, bronchiectasis, lung fibrosis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İlknur Naz Gürşan
Izmir, 35620
İlknur N Gürşan, 05356954634, ilknurnaz4@gmail.com
Hulya Sahin, Assoc Prof
About this study
Official title: 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.
Read the 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.
- Conditions
- Copd, Tuberculosis, Quality of Life
- Being tested
- Functional Outcome Measurements
- Keywords
- copd, tuberculosis, exercise capacity, quality of life
- 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.
Functional Outcome MeasurementsOther
Dyspnea Exercise capacity Quality of life assessment
| Study group | Role | What they receive |
|---|---|---|
| COPD patients with tuberculous sequelae | COPD patients with tuberculous sequelae Receives: Other: Functional Outcome Measurements | |
| COPD patients without tuberculosis sequela | COPD patients with tuberculous sequelae Receives: Other: Functional Outcome Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Six minutes walk test
Measured: 6 minutes- baseline
Secondary outcomes (3)
Dyspnea Assessment
Medical Research Council Scale(MRC)
Measured: 5 minutes- baseline
COPD Assessment
COPD Assessment Test (CAT
Measured: 5 minutes- baseline
Quality of Life Assessment
St. George Respiratory Questionaire
Measured: 20 minutes- baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 May 2020
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
- Investigators
- Hulya Sahin, Principal investigator, Izmir Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721080
- Sponsor's protocol ID
- IKC145
- Status last verified
- Feb 2021
- First submitted
- 19 Jan 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulmonary Tuberculosis Sequelae on Functional Outcomes in Patients With COPD
- ClinicalTrials.gov ID
- NCT04721080
- Acronym / sponsor ID
- IKC145
- Conditions
- Copd, Tuberculosis, Quality of Life
- Keywords
- copd, tuberculosis, exercise capacity, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 22 Jan 2021 (actual)
- 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.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients with tuberculous sequelae | – | Other: Functional Outcome MeasurementsCOPD patients with tuberculous sequelae |
| COPD patients without tuberculosis sequela | – | Other: Functional Outcome MeasurementsCOPD patients with tuberculous sequelae |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients with tuberculous sequelae and COPD patients without tuberculosis sequela
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Being in a COPD attack
- The patient has additional pulmonary comorbidity such as Lung Ca, bronchiectasis, lung fibrosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Outcome MeasurementsDyspnea Exercise capacity Quality of life assessment | Other | COPD patients with tuberculous sequelae, COPD patients without tuberculosis sequela |
Primary outcome
Exercise Capacity
Time frame: 6 minutes- baseline
Six minutes walk test
3 secondary outcomes
Dyspnea Assessment
Time frame: 5 minutes- baseline
COPD Assessment
Time frame: 5 minutes- baseline
Quality of Life Assessment
Time frame: 20 minutes- baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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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.
Hulya Sahin principal investigator
Izmir Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Copd and Tuberculosis, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İlknur N Gürşan, Assoc Prof (05356954634, ilknurnaz4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Capacity (time frame: 6 minutes- baseline). 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 Mar 2021.