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Clinical Trials/TCTR20240709001
TCTR20240709001
Recruiting
Phase 3

Effectiveness of Nebulized Bronchodilator - Enhanced Sputum Induction Versus Conventional Sputum Induction in Thai Patients with Clinically Suspected Smear-Negative Pulmonary Tuberculosis; A Randomized Controlled Trial

Faculty of Medicine, Chulalongkorn University0 sites200 target enrollmentJuly 9, 2024

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Thai Patients with Clinically Suspected Smear-Negative Pulmonary Tuberculosis
Sponsor
Faculty of Medicine, Chulalongkorn University
Enrollment
200
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 9, 2024
End Date
March 31, 2025
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Thai patients aged 18 years or older.
  • 2\. Exhibiting clinical symptoms or radiological findings consistent with pulmonary tuberculosis, and suspected by the attending physician to have pulmonary tuberculosis or pulmonary tuberculosis in conjunction with extrapulmonary tuberculosis.
  • 3\. Initial sputum examination (spot sputum) shows no evidence of tuberculosis through acid\-fast bacilli staining and Xpert MTB/RIF Ultra testing, or patients unable to produce effective sputum samples due to insufficient cough strength.
  • 4\. Not currently undergoing treatment for tuberculosis or latent tuberculosis.
  • 5\. Voluntarily consent to participate in the research and sign the informed consent form.

Exclusion Criteria

  • 1\. Pregnant women.
  • 2\. Patients with bronchospasm or a history of severe bronchospasm induced by sputum induction, or a history of pulmonary function tests showing a decrease in FEV1 by more than 20% post\-sputum induction.
  • 3\. Patients with severe respiratory issues, including:
  • 3\.1\. Severe or uncontrolled asthma, meeting at least one of the following criteria:
  • 3\.1\.1\. Exhibiting more than three of the following symptoms:
  • (a) Daytime breathlessness more than twice a week.
  • (b) Nighttime breathlessness more than once a week.
  • (c) Use of emergency inhalation medication more than twice a week.
  • (d) Asthma symptoms affecting daily activities at least once a week (Activity limitation).
  • 3\.1\.2\. History of pulmonary function tests with FEV1 less than 60% of the predicted value by age, or less than 1 liter, or peak expiratory flow rate variability greater than 30%.

Outcomes

Primary Outcomes

Not specified

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