Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01365702

Collaborator

(none)

Enrollment

Location

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Disease, Obstructive Tuberculosis

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

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Efficacy of Tiotripium in Patients With Airflow Obstruction Due to TB Destroyed Lung

Study Start Date :

Jun 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Tiotropium in TB destroyed lung

Outcome Measures

Primary Outcome Measures

St-George respiratory questionnaire(SGRQ) [6 months after initiation of tiotropium once-daily inhalation]

Secondary Outcome Measures

lung function [6mo after initiation of tiotropium once-daily inhalation]
cough VAS [6mo after initiation of tiotropium once-daily inhalation]
adverse reaction of tiotropium [6 months after initiation of tiotropium once-daily inhalation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-707

Sponsors and Collaborators

Seoul National University Bundang Hospital

Investigators

Principal Investigator: Sei Won Lee, M.D., Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical research center, Seoul National University Bundang Hospital