Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung

NCT ID: NCT01365702

Last Updated: 2011-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-12-31

Brief Summary

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The aim of this study to evaluate clinical efficacy of tiotropium in patients with airflow obstruction due to Tuberculosis (TB) destroyed lung.

Detailed Description

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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

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Lung Disease, Obstructive Tuberculosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tiotropium in TB destroyed lung

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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%

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Internal Medicine, Seoul National University Bundang Hospital

Principal Investigators

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Sei Won Lee, M.D.

Role: 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

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Sei Won Lee, M.D.

Role: primary

82-31-787-7053

Other Identifiers

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SNUBH_TLD and spiriva

Identifier Type: -

Identifier Source: org_study_id

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