UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056274 |
|---|---|
| Receipt number | R000062379 |
| Scientific Title | Evaluation of the effect of airway clearance with an oscillatory positive expiratory pressure device (Aerobika) in patients with nontuberculous mycobacterial pulmonary disease: a randomized controlled trial. |
| Date of disclosure of the study information | 2024/11/26 |
| Last modified on | 2024/11/26 12:37:20 |
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Basic information
Public title
Evaluation of the effect of airway clearance with an oscillatory positive expiratory pressure device (Aerobika) in patients with nontuberculous mycobacterial pulmonary disease: a randomized controlled trial.
Acronym
Evaluation of the effect of airway clearance with an oscillatory positive expiratory pressure device in patients with nontuberculous mycobacterial pulmonary disease: a randomized controlled trial.
Scientific Title
Evaluation of the effect of airway clearance with an oscillatory positive expiratory pressure device (Aerobika) in patients with nontuberculous mycobacterial pulmonary disease: a randomized controlled trial.
Scientific Title:Acronym
Evaluation of the effect of airway clearance with an oscillatory positive expiratory pressure device in patients with nontuberculous mycobacterial pulmonary disease: a randomized controlled trial.
Region
| Japan |
Condition
Condition
nontuberculous mycobacterial pulmonary disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective was to determine the efficacy and safety of airway clearance with an oscillatory positive expiratory pressure device for nontuberculous mycobacterial pulmonary disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Main outcome is quality of life at 4 and 8 weeks after the start of the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
In the intervention group, airway clearance with an oscillatory positive expiratory pressure device will be performed for a minimum of two sessions per day for eight weeks, with each session lasting a maximum of 20 minutes.
Interventions/Control_2
In the control group, airway clearance with active cycle breathing of technique will be performed for a minimum of 2 sessions per day for 8 weeks, with each session lasting a maximum of 20 minutes.
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
Inclusion criteria were patients with nontuberculous mycobacterial pulmonary disease admitted for treatment who met all of the following criteria
1. bronchiectasis on chest CT within 2 years prior to study entry
2. cough and sputum symptoms
3. able to use OPEP and have cognitive function to answer the questionnaire
Key exclusion criteria
Exclusion criteria are as follows
1. those who used physiotherapy or devices such as OPEP at present or within the past year
2. Patients who were hospitalized urgently due to exacerbation, etc.
3. those with unstable medical conditions 4. those with any acute disease requiring treatment
4. who require treatment for any acute illness Patients with medical conditions or symptoms that are contraindications to the use of OPEP
6. patients with chronic obstructive pulmonary disease, interstitial lung disease, or bronchial asthma
7. patients with malignant tumors
8. current smokers
9. Persons with dementia or psychiatric diseases that the principal investigator or project leader determines to be difficult to evaluate
10. any other person who is judged to be ineligible by the Principal Investigator or a research associate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kozo |
| Middle name | |
| Last name | Morimoto |
Organization
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Division name
Respiratory Diseases Center
Zip code
2048522
Address
3-1-24, Matsuyama, Kiyose, Tokyo, Japan.
TEL
0424914111
morizo1016@gmail.com
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Ono |
Organization
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Division name
Respiratory Care and Rehabilitation Center
Zip code
2048522
Address
3-1-24, Matsuyama, Kiyose, Tokyo, Japan.
TEL
0424914111
Homepage URL
k.ono2964@gmail.com
Sponsor or person
Institute
Fukujuji Hospital,Japan Anti-Tuberculosis Association
Institute
Department
Personal name
Funding Source
Organization
Harada Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Address
3-1-24, Matsuyama, Kiyose, Tokyo, Japan.
Tel
0424914111
chiken@fukujuji.org
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
| 2024 | Year | 11 | Month | 26 | 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
| 2024 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 05 | 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
| 2024 | Year | 11 | Month | 26 | Day |
Last modified on
| 2024 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062379
