Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung

• Conditions: Lung Disease, Obstructive; Tuberculosis

• Registration Number: NCT01365702
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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 Timeline

• Study First Submitted: 2011-05-31
• Status Verified: 2011-06
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-03
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-07
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
St-George respiratory questionnaire(SGRQ)	6 months after initiation of tiotropium once-daily inhalation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of