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Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
Information provided by:
Seoul National University Bundang Hospital Identifier:
First received: May 31, 2011
Last updated: June 6, 2011
Last verified: June 2011
The aim of this study to evaluate clinical efficacy of tiotropium in patients with airflow obstruction due to Tuberculosis (TB) destroyed lung.

Lung Disease, Obstructive

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Efficacy of Tiotripium in Patients With Airflow Obstruction Due to TB Destroyed Lung

Resource links provided by NLM:

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • St-George respiratory questionnaire(SGRQ) [ Time Frame: 6 months after initiation of tiotropium once-daily inhalation ]

Secondary Outcome Measures:
  • lung function [ Time Frame: 6mo after initiation of tiotropium once-daily inhalation ]
  • cough VAS [ Time Frame: 6mo after initiation of tiotropium once-daily inhalation ]
  • adverse reaction of tiotropium [ Time Frame: 6 months after initiation of tiotropium once-daily inhalation ]

Estimated Enrollment: 70
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Tiotropium in 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01365702

Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Sei Won Lee, M.D.    82-31-787-7053   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Principal Investigator: 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
  More Information

Responsible Party: Sei Won Lee/Assistant professor, Department of Internal Medicine, Seoul National University Bundang Hospital Identifier: NCT01365702     History of Changes
Other Study ID Numbers: SNUBH_TLD and spiriva
Study First Received: May 31, 2011
Last Updated: June 6, 2011

Keywords provided by Seoul National University Bundang Hospital:
tuberculous destroyed lung

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017