A Cross-over study to compare the Lung Flute method with hypertonic saline inhalation for the examination of M. tuberculosis in induced sputum

A Cross-over study to compare the Lung Flute method with hypertonic saline inhalation for the examination of M. tuberculosis in induced sputum - A study to compare the Lung Flute method with hypertonic saline inhalation in TB

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004676

Enrollment

120

Registered

2010-12-08

Start date

2010-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary tuberculosis

Interventions

(A) Examinations are performed by spontaneous sputum on day 1, the Lung Flute on day 2, and hypertonic saline inhalation on day 3. The period of observation : day 1 to day 7. (60 cases in each gro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with pulmonary tuberculosis 2. Hospitalized patients in the TB ward (or in a negative ventilation room) 3. Sputum ABF smear below 2+ (Gaffky 7 in Ziehl-Neelsen staining) on admission 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. ABF sputum smear 3+ before admission 2. Patients who expectorate sputum at any time 3. Laryngeal tuberculosis 4. Bronchial asthma 5. Hemoptysis 6. Respiratory failure (Spo2 below 90% on breathing room air) 7. Pneumothorax 8. Hyperventilation syndrome (including past history) 9. Poorly controlled hypertension 10. Unable to understand sputum induction 11. Inability to follow sputum induction instruction 12. Pregnant women 13. Unsuitable for participation by the decision of the responsible doctors 14. Over days after the start of TB treatment

Design outcomes

Primary

Measure	Time frame
The results of AFB smear, culture, and TB PCR in (induced) sputum	—

Secondary

Measure	Time frame
1. Success rate of sputum induction and timing of expectoration 2. Condition and amount of sputum 3. Oxygen saturation before and after sputum induction 4. Adverse events	—

Countries

Japan

Contacts

Public ContactKumiko Hiratake

Tokyo Metropolitan Tama Medical Center Pulmonary Medicine

akira_fujita@tmhp.jp042-323-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026