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
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.
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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