UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of oscillatory positive expiratory pressure device (Aerobika).
Acronym	Efficacy of Aerobika
Scientific Title	The efficacy of oscillatory positive expiratory pressure device (Aerobika).
Scientific Title:Acronym	Efficacy of Aerobika
Region	Japan

Condition
Condition	Chronic Obstructive Pulmonary Disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To observe the additive efficacy of Aerobika on beneficial effect of long acting bronchodilator in stable COPD patients who were self-reported sputum-producers.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in FEV1 before and after 4-week treatment with Aerobika.
Key secondary outcomes	Following parameters will be assessed for before and at 4-week 4-week treatment with Aerobika. 1. VC, FVC, V50, and V25 2. IOS(R5, R5ins, R5exp, R20, X5, X5ins, X5exp, Fres, Ax) 3. 6 minute-walking test 4. CAT score, mMRC 5. Acute exacerbation

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Intervantion Participants use Aerobika twice daily for 10min before long acting bronchodilator inhalation. Treatment time is 4 weeks.
Interventions/Control_2	Control Participants continue long acting bronchodilator inhalation. Treatment time is 4 weeks.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subject has post-long acting bronchodilator forced expiratory volume in first second (FEV1) <= 80% predicted. Subject has respiratory symptoms >= 10 on the CAT total score, and has the phlegm symptoms >= 2 on the CAT phlegm score. Subject has declared that he/she has stopped smoking for at least 8 weeks prior to entering the study Subject has read, understood, and signed the informed consent form.
Key exclusion criteria	The condition that the investigator judges to exclude from the study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Masamichi Middle name Last name Mineshita
Organization	St. Marianna University School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki-City, Kanagawa, Japan
TEL	044-977-8111
Email	m-mine@marianna-u.ac.jp

Public contact
Name of contact person	1st name Masamichi Middle name Last name Mineshita
Organization	St. Marianna University School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki-City, Kanagawa, Japan
TEL	044-977-8111
Homepage URL
Email	m-mine@marianna-u.ac.jp

Sponsor
Institute	Division of Respiratory Medicine, Department of Internal Medicine, St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Division of Respiratory Medicine, Department of Internal Medicine, St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Human research and ethics committee of St. Marianna University School of Medicine
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki-City, Kanagawa, Japan
Tel	044-977-8111
Email	k-sienbu.mail@marianna-u.ac.jp

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	2018 Year 07 Month 01 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	6
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	Terminated
Date of protocol fixation	2018 Year 05 Month 21 Day
Date of IRB	2018 Year 05 Month 21 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2021 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 21 Day
Last modified on	2021 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036836