UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002164 |
|---|---|
| Receipt number | R000002648 |
| Scientific Title | Study on efficacy of a small self-powed audio device (Lung Flute) for spurum induction |
| Date of disclosure of the study information | 2009/07/03 |
| Last modified on | 2009/07/03 17:45:20 |
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Basic information
Public title
Study on efficacy of a small self-powed audio device (Lung Flute) for spurum induction
Acronym
Study on efficacy of Lung Flute
Scientific Title
Study on efficacy of a small self-powed audio device (Lung Flute) for spurum induction
Scientific Title:Acronym
Study on efficacy of Lung Flute
Region
| Japan |
Condition
Condition
nonproductive cough
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of Lung Flute for spurum induction compared with inhaled hypertonic saline aerosol
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Success rate of sputum induction
Key secondary outcomes
Tne total number of cells on one slide (more or less than 400 cells)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients whose chief complaint is nonproductive cough
Key exclusion criteria
Patients on Home Oxygen Therapy (HOT)
Patients who can not understand the maneuver
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Fujimura |
Organization
Kanazawa University Hospital
Division name
Respiratory Medicine, Cellular Transplantation Biology
Zip code
Address
Takara-machi 13-1, Kanazawa-city, Ishikawa
TEL
076-265-2274
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Fujimura |
Organization
Kanazawa University Hospital
Division name
Respiratory Medicine, Cellular Transplantation Biology
Zip code
Address
Takara-machi 13-1, Kanazawa-city, Ishikawa
TEL
076-265-2274
Homepage URL
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 03 | 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
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
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
We hypothesized that the success rate of sputum induction is higher by Lung Flute and hypertonic saline than by either of them.
Management information
Registered date
| 2009 | Year | 07 | Month | 03 | Day |
Last modified on
| 2009 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002648
