Lung Disease, ObstructiveNCT01365702
Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung
An observational study of Lung Disease, Obstructive and Tuberculosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The aim of this study to evaluate clinical efficacy of tiotropium in patients with airflow obstruction due to Tuberculosis (TB) destroyed lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Disease, Obstructive, Tuberculosis
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Dec 2012
- 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: Patients with TB destroyed lung visiting Seoul National University Bundang Hospital Respiratory center for chronic respiratory symptoms will be screened for study participants. Among the patients, those with definite pulmonary TB histor with airflow obstruction on their PFT were entrolled.
Who may be able to join
- previous pulmonary tuberculosis history
- never smoker or light smoker (<10 pack-year)
- destruction of lung parenchyme, lung volume loss,secondary bronchiectasis due to tuberculosis in chest radiographs or chest CT, confirmed by board-certificate radiologist
- airflow obstruction confirmed by pulmonary function test, FEV1/FVC <70%
Who cannot join
- patients do not agree with study enrollment
- patients with active tuberculosis or current antituberculous medication
- patients under chemotherapy or other immunosuppressant therapy such as glucocorticoid.
- active infection such as pneumonia, tuberculosis
- patients who are illiterate
- patients with dementia
- pregnant or to be pregnant
- previous lung resection surgery history
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Sei Won Lee, M.D., 82-31-787-7053, seiwon@snubh.org
About this study
Official title: Clinical Efficacy of Tiotripium in Patients With Airflow Obstruction Due to TB Destroyed Lung
The aim of this study to evaluate clinical efficacy of tiotropium in patients with airflow obstruction due to Tuberculosis (TB) destroyed lung.
Read the detailed description
Tuberculosis can cause lung parenchymal destruction, volume loss, secondary bronchiectasis. Patients with TB destroyed lung complain chronic respiratory symptoms, such as chronic cough, sputum, dyspnea, exercise intolerance, and acute exacerbations. Some of them have chronic airflow obstructions on pulmonary function tests, similar to those of smokers.
Previous large randomized controlled trials, targeting patients with smoking related moderate to severe COPD,demonstrated that tiotropium improved quality of life and respiratory symptom with tolerable long-term safety. The investigators want to evaluate whether tiotropium can improve chronic respiratory symptom,an lung function in patients with COPD due to TB destroyed lung.
- Conditions
- Lung Disease, Obstructive, Tuberculosis
- Keywords
- COPD, tiotropium, tuberculous destroyed lung
- Medical subject headings
- Lung Diseases, Obstructive, Tuberculosis, Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| Tiotropium in TB destroyed lung | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
St-George respiratory questionnaire(SGRQ)
Measured: 6 months after initiation of tiotropium once-daily inhalation
Secondary outcomes (3)
lung function
Measured: 6mo after initiation of tiotropium once-daily inhalation
cough VAS
Measured: 6mo after initiation of tiotropium once-daily inhalation
adverse reaction of tiotropium
Measured: 6 months after initiation of tiotropium once-daily inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Disease, ObstructiveStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sei Won Lee, M.D., Principal investigator, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical research center, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365702
- Sponsor's protocol ID
- SNUBH_TLD and spiriva
- Status last verified
- Jun 2011
- First submitted
- 31 May 2011
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Tiotripium in Patients With Airflow Obstruction Due to TB Destroyed Lung
- ClinicalTrials.gov ID
- NCT01365702
- Acronym / sponsor ID
- SNUBH_TLD and spiriva
- Conditions
- Lung Disease, Obstructive, Tuberculosis
- Keywords
- COPD, tiotropium, tuberculous destroyed lung
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Jun 2011 (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.
The aim of this study to evaluate clinical efficacy of tiotropium in patients with airflow obstruction due to Tuberculosis (TB) destroyed lung.
Detailed description
Tuberculosis can cause lung parenchymal destruction, volume loss, secondary bronchiectasis. Patients with TB destroyed lung complain chronic respiratory symptoms, such as chronic cough, sputum, dyspnea, exercise intolerance, and acute exacerbations. Some of them have chronic airflow obstructions on pulmonary function tests, similar to those of smokers.
Previous large randomized controlled trials, targeting patients with smoking related moderate to severe COPD,demonstrated that tiotropium improved quality of life and respiratory symptom with tolerable long-term safety. The investigators want to evaluate whether tiotropium can improve chronic respiratory symptom,an lung function in patients with COPD due to TB destroyed lung.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tiotropium in TB destroyed lung | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with TB destroyed lung visiting Seoul National University Bundang Hospital Respiratory center for chronic respiratory symptoms will be screened for study participants. Among the patients, those with definite pulmonary TB histor with airflow obstruction on their PFT were entrolled.
Key inclusion criteria (4 listed)
- previous pulmonary tuberculosis history
- never smoker or light smoker (<10 pack-year)
- destruction of lung parenchyme, lung volume loss,secondary bronchiectasis due to tuberculosis in chest radiographs or chest CT, confirmed by board-certificate radiologist
- airflow obstruction confirmed by pulmonary function test, FEV1/FVC <70%
Key exclusion criteria (8 listed)
- patients do not agree with study enrollment
- patients with active tuberculosis or current antituberculous medication
- patients under chemotherapy or other immunosuppressant therapy such as glucocorticoid.
- active infection such as pneumonia, tuberculosis
- patients who are illiterate
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
St-George respiratory questionnaire(SGRQ)
Time frame: 6 months after initiation of tiotropium once-daily inhalation
3 secondary outcomes
lung function
Time frame: 6mo after initiation of tiotropium once-daily inhalation
cough VAS
Time frame: 6mo after initiation of tiotropium once-daily inhalation
adverse reaction of tiotropium
Time frame: 6 months after initiation of tiotropium once-daily inhalation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
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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.
Sei Won Lee, M.D. principal investigator
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical research center, Seoul National University Bundang 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 Lung Disease, Obstructive and Tuberculosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 8 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 7 Jun 2011. 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 South Korea. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
St-George respiratory questionnaire(SGRQ) (time frame: 6 months after initiation of tiotropium once-daily inhalation). 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 7 Jun 2011.