Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung

NCT01365702 | Unknown

• 1 other identifier: SNUBH_TLD and spiriva
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Disease, Obstructive; Tuberculosis

Keywords

COPD; tiotropium; tuberculous destroyed lung

Outcome Measures

Primary Outcomes (1)

• St-George respiratory questionnaire(SGRQ)

  6 months after initiation of tiotropium once-daily inhalation

Secondary Outcomes (3)

• 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

Study Arms (1)

Tiotropium in TB destroyed lung

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Obstructive; Tuberculosis; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 3, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 7, 2011

Record last verified: 2011-06

Locations

KR (1)