Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01365702
• Other study ID #: SNUBH_TLD and spiriva
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2011
• Last updated: June 6, 2011
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: June 2011
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Disease, Obstructive
• Lung Diseases
• Lung Diseases, Obstructive
• Tuberculosis

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	St-George respiratory questionnaire(SGRQ)		6 months after initiation of tiotropium once-daily inhalation	No
Secondary	lung function		6mo after initiation of tiotropium once-daily inhalation	Yes
Secondary	cough VAS		6mo after initiation of tiotropium once-daily inhalation	No
Secondary	adverse reaction of tiotropium		6 months after initiation of tiotropium once-daily inhalation	Yes