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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002164
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kanazawa University Graduate School of Medical Science
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002648

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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