Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung

June 6, 2011 updated by: Seoul National University Bundang Hospital

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

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

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Tiotropium in TB destroyed lung

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
St-George respiratory questionnaire(SGRQ)
Time Frame: 6 months after initiation of tiotropium once-daily inhalation
6 months after initiation of tiotropium once-daily inhalation

Secondary Outcome Measures

Outcome Measure
Time Frame
lung function
Time Frame: 6mo after initiation of tiotropium once-daily inhalation
6mo after initiation of tiotropium once-daily inhalation
cough VAS
Time Frame: 6mo after initiation of tiotropium once-daily inhalation
6mo after initiation of tiotropium once-daily inhalation
adverse reaction of tiotropium
Time Frame: 6 months after initiation of tiotropium once-daily inhalation
6 months after initiation of tiotropium once-daily inhalation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (Estimate)

June 3, 2011

Study Record Updates

Last Update Posted (Estimate)

June 7, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH_TLD and spiriva

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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