Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Seoul National University Bundang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01365702
First received: May 31, 2011
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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


Condition
Lung Disease, Obstructive
Tuberculosis

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • lung function [ Time Frame: 6mo after initiation of tiotropium once-daily inhalation ] [ Designated as safety issue: Yes ]
  • cough VAS [ Time Frame: 6mo after initiation of tiotropium once-daily inhalation ] [ Designated as safety issue: No ]
  • adverse reaction of tiotropium [ Time Frame: 6 months after initiation of tiotropium once-daily inhalation ] [ Designated as safety issue: Yes ]

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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365702

Locations
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    seiwon@snubh.org   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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

No publications provided

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

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

Additional relevant MeSH terms:
Lung Diseases
Tuberculosis
Lung Diseases, Obstructive
Respiratory Tract Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014