Clinical trial NCT01365702: Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung
Official title: Clinical Efficacy of Tiotripium in Patients With Airflow Obstruction Due to TB Destroyed Lung
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Disease, Obstructive
Tuberculosis
Keywords: COPD
tiotropium
tuberculous destroyed lung
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: St-George respiratory questionnaire(SGRQ)
timeFrame: 6 months after initiation of tiotropium once-daily inhalation
Secondary outcomes:
measure: lung function
timeFrame: 6mo after initiation of tiotropium once-daily inhalation
measure: cough VAS
timeFrame: 6mo after initiation of tiotropium once-daily inhalation
measure: adverse reaction of tiotropium
timeFrame: 6 months after initiation of tiotropium once-daily inhalation
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical research center, Seoul National University Bundang Hospital
name: Sei Won Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: