UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017425
Receipt number R000018181
Scientific Title Vibratory stimulation on cervical trachea for enhancement of sputum expectoration.
Date of disclosure of the study information 2015/05/07
Last modified on 2015/05/06 10:12:33

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Basic information

Public title

Vibratory stimulation on cervical trachea for enhancement of sputum expectoration.

Acronym

Sputum expectoration by traceal vibratory stimulation.

Scientific Title

Vibratory stimulation on cervical trachea for enhancement of sputum expectoration.

Scientific Title:Acronym

Sputum expectoration by traceal vibratory stimulation.

Region

Japan


Condition

Condition

Chronic inflammatory airway diseases

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We developed a new oscillation technique for enhancing sputum expectoration, that is the vibratory stimulation on cervical trachea. We compared its efficacy with Acapella, one of the current oscillation thechniques.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The degree of improvement of difficulties in expectoration sputum.

Key secondary outcomes

QOL, Pulmonary function tests


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

After 2 weeks period of observation period, the tracheal vibration method and Acapella was conducted for 4 weeks by cross-over fashion with 4 weeks period of wash-out phase in between.

Interventions/Control_2

After 2 weeks period of observation period, the tracheal vibration method and Acapella was conducted for 4 weeks by cross-over fashion with 4 weeks period of wash-out phase in between.

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

# Those who were diagnosed as having chronic pulmonary diseases including COPD, chronic bronchitis, bronchiectasis, old tuberculosis, etc, who are suffering from chronic productive cough.
# Those who have 5 times or more of sputum a day which takes more than 30 seconds to be expectorated.
# No change of medication 4 weeks prior to the entry to the study.

Key exclusion criteria

# Systemic corticosteroi use 4 weeks prior to the entry to the study.
# Respiratory tract infection 4 weeks prior to the entry to the study.
# Co-existence of GERD, neuromuscular diseases, active airway bleeding, uncontrolled asthma, recent pneumothorax.
# Operation of thorax or abdomen 4 weeks prior to the entry to the study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuhiro Kamimura

Organization

National Hospital Organization Disaster Medical Center

Division name

Pulmonology Department

Zip code


Address

Midorimachi 3256, Tachikawa, Tokyo, Japan

TEL

81-42-526-5511

Email

tdmckamimura@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsuhiro Kamimura

Organization

National Hospital Organization Disaster Medical Center

Division name

Pulmonology Department

Zip code


Address

Midorimachi 3256, Tachikawa, Tokyo, Japan

TEL

81-42-526-5511

Homepage URL


Email

tdmckamimura@yahoo.co.jp


Sponsor or person

Institute

National Hospital Organization Disaster Medical Center

Institute

Department

Personal name



Funding Source

Organization

Suzuken Memorial Fundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

2015 Year 05 Month 07 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2011 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 05 Month 06 Day

Last modified on

2015 Year 05 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018181


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name