UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032655
Receipt No. R000036836
Scientific Title The efficacy of oscillatory positive expiratory pressure device (Aerobika).
Date of disclosure of the study information 2018/07/01
Last modified on 2018/08/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Masamichi Mineshita
Organization St. Marianna University School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code
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
Middle name
Last name Masamichi Mineshita
Organization St. Marianna University School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code
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
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
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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 07 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
2018 Year 05 Month 21 Day
Last modified on
2018 Year 08 Month 01 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.