UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032655 |
|---|---|
| Receipt number | 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 | 2021/11/22 12:11:44 |
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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
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
m-mine@marianna-u.ac.jp
Sponsor or person
Institute
Division of Respiratory Medicine, Department of Internal Medicine, St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036836
