Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01365702

Enrollment

Registered

2011-06-03

Start date

2011-06-30

Completion date

2012-12-31

Last updated

2011-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Disease, Obstructive, Tuberculosis

Keywords

COPD, tiotropium, tuberculous destroyed lung

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results