UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004676 |
|---|---|
| Receipt number | R000005560 |
| Scientific Title | A Cross-over study to compare the Lung Flute method with hypertonic saline inhalation for the examination of M. tuberculosis in induced sputum |
| Date of disclosure of the study information | 2010/12/08 |
| Last modified on | 2015/11/24 11:32:07 |
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Basic information
Public title
A Cross-over study to compare the Lung Flute method with hypertonic saline inhalation for the examination of M. tuberculosis in induced sputum
Acronym
A study to compare the Lung Flute method with hypertonic saline inhalation in TB
Scientific Title
A Cross-over study to compare the Lung Flute method with hypertonic saline inhalation for the examination of M. tuberculosis in induced sputum
Scientific Title:Acronym
A study to compare the Lung Flute method with hypertonic saline inhalation in TB
Region
| Japan |
Condition
Condition
Pulmonary tuberculosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the equivalence of the Lung Flute and hypertonic saline inhalation for sputum induction in mycobacterial (tuberculosis) examination
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The results of AFB smear, culture, and TB PCR in (induced) sputum
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
(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 group).
Interventions/Control_2
(B) Examinations are performed by spontaneous sputum on day 1, hypertonic saline inhalation on day 2, and the Lung Flute on day 3.
The period of observation : day 1 to day 7.
(60 cases in each group).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Fujita |
Organization
Tokyo Metropolitan Health and Medical Corporation Tama-Nambu Chiiki Hospital
Division name
Internal Medicine
Zip code
Address
2-1-2 Nakazawa, Tama-shi, Tokyo
TEL
042-338-5111
akira_fujita@tokyo-hmt.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kumiko Hiratake |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Pulmonary Medicine
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-323-5111
Homepage URL
akira_fujita@tmhp.jp
Sponsor or person
Institute
Sputum Induction Research Group
Institute
Department
Personal name
Funding Source
Organization
Acoustic Innovations, Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京都立多摩総合医療センター（東京都）
国立病院機構茨城東病院（茨城県）
（公財）結核予防会複十字病院（東京都）
（公財）結核予防会結核研究所 （東京都）
国立病院機構東名古屋病院（愛知県）
大阪府立病院機構大阪府立呼吸器・アレルギー医療センター（大阪府）
国立病院機構東広島医療センター（広島県）
金沢市立病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Total of 63 patients were analyzed. A crossover study of the Lung Flute method (LF) and hypertonic saline inhalation (HSI) demonstrated no significant difference in grading of smear, positive culture rate, time to positivity (days), and PCR positivity between LF and HSI. The Lung Flute method was equivalent in terms of bacteriological diagnosis to hypertonic saline inhalation in hospitalized patients with tuberculosis.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 07 | Day |
Last modified on
| 2015 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005560
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