UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062433 |
|---|---|
| Receipt number | R000071453 |
| Scientific Title | Clinical Utility of the Aerobika Oscillating Positive Expiratory Pressure Device for Airway Secretion Clearance in Patients with Asthma and Allergic Bronchopulmonary Mycosis (ABPM): A Prospective Observational Study |
| Date of disclosure of the study information | 2026/08/03 |
| Last modified on | 2026/08/01 10:22:25 |
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Basic information
Public title
Clinical Utility of the Aerobika Oscillating Positive Expiratory Pressure Device for Airway Secretion Clearance in Patients with Asthma and Allergic Bronchopulmonary Mycosis (ABPM): A Prospective Observational Study
Acronym
Clinical Utility of the Aerobika Oscillating Positive Expiratory Pressure Device for Airway Secretion Clearance in Patients with Asthma and Allergic Bronchopulmonary Mycosis (ABPM): A Prospective Observational Study
Scientific Title
Clinical Utility of the Aerobika Oscillating Positive Expiratory Pressure Device for Airway Secretion Clearance in Patients with Asthma and Allergic Bronchopulmonary Mycosis (ABPM): A Prospective Observational Study
Scientific Title:Acronym
Clinical Utility of the Aerobika Oscillating Positive Expiratory Pressure Device for Airway Secretion Clearance in Patients with Asthma and Allergic Bronchopulmonary Mycosis (ABPM): A Prospective Observational Study
Region
| Japan |
Condition
Condition
Asthma and Allergic Bronchopulmonary Mycosis
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of adjunctive Aerobika use on sputum symptoms, as assessed by the CASA-Q sputum domain, in patients with asthma and allergic bronchopulmonary mycosis (ABPM).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline to Week 12 in the CASA-Q sputum symptom domain score
Key secondary outcomes
Comparison between baseline (immediately before study initiation) and Week 12 for the following parameters:
-CASA-Q cough symptom domain score
-Patient-reported ease of sputum expectoration assessed using a visual analog scale (VAS)
(0 mm = unable to expectorate sputum at all; 100 mm = able to expectorate sputum very easily)
-Asthma control and quality of life assessed by the Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
-Hematological parameters: red blood cell count, hemoglobin, reticulocyte count, white blood cell count, platelet count, lymphocyte count, neutrophil count, and eosinophil count
-Pulmonary function: FEV1, FEF25-75, and FVC
-Airway inflammation marker: fractional exhaled nitric oxide (FeNO)
-Respiratory impedance measured by the forced oscillation technique (FOT; MostGraph): R5, R20, R5-R20, X5, and Fres
-Type 2 inflammatory biomarkers
-Urinary leukotriene E4 (LTE4) (measured in a research laboratory; not covered by health insurance)
-Serum and urinary eosinophil-derived neurotoxin (EDN) (measured in a research laboratory; not covered by health insurance)
-Peripheral blood eosinophil count
-Between-group comparison: comparison of the change in CASA-Q scores between the Aerobika use group and the non-use group
-Incidence of adverse events throughout the observation period
-Number of asthma exacerbations and ABPM relapses throughout the observation period
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Inclusion Criteria
1. Outpatients aged 18 years or older who have been receiving standard treatment for asthma or allergic bronchopulmonary mycosis (ABPM) at our institution.
(The diagnosis of ABPM will be based on Reference 4.)
2. Patients who have not experienced an asthma exacerbation or recurrence of ABPM within 24 weeks prior to obtaining informed consent.
3. Patients whose treatment for the underlying disease has remained unchanged for at least 12 weeks prior to obtaining informed consent, whose disease condition is stable, and who continue to have chronic sputum symptoms.
* Chronic sputum symptoms are defined as sputum symptoms persisting for at least 12 weeks as confirmed by interview. In addition, a CASA-Q sputum symptom domain score of 80 or less must have been confirmed on two occasions separated by at least 4 weeks during the screening period and at study entry.
** Rationale for the cutoff value of 80: In patients with severe asthma eligible for biologic therapy, 79% had a CASA-Q sputum symptom domain score of 80 or less, whereas only 42% had a score of 60 or less (Reference 6). To include a broader range of patients with asthma, a cutoff value of 80 was adopted in this study.
4. Patients who are considered by the treating physician to have no contraindication to continued use of Aerobika.
5. Patients who have provided written informed consent for the use of Aerobika.
Key exclusion criteria
Exclusion Criteria
1. Patients who are unable to understand or properly use the Aerobika device.
2. Patients who have experienced an asthma exacerbation or recurrence of ABPM within the previous 24 weeks.
3. Patients currently using other airway clearance or sputum clearance devices.
4. Patients with comorbid conditions that may affect study assessments, including autoimmune diseases and heart failure.
5. Patients who are pregnant or have untreated pneumothorax, progressive hemoptysis, elevated intracranial pressure, hemodynamic instability, or other conditions in which Aerobika use may be inappropriate.
6. Patients deemed unsuitable for participation in the study by the principal investigator or sub-investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Sekiya |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Allergy and Respiratory Medicine
Zip code
252-0392
Address
18-1 Sakuradai Minami-ku Sagamihara, Kanagawa, Japan.
TEL
042-742-8311
sekiya.kiyoshi.fe@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Kohshi |
| Middle name | |
| Last name | Fukuda |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Allergy and Respiratory Medicine
Zip code
252-0392
Address
18-1 Sakuradai Minami-ku Sagamihara, Kanagawa, Japan.
TEL
042-742-8311
Homepage URL
koshi.fukuda@med.toho-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
The Medical Team of Harada Corporation.
Trudell Medical International (TMI), Canada,
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Canada
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sagamihara National Hospital ethical committee
Address
18-1 Sakuradai Minami-ku Sagamihara, Kanagawa, Japan.
Tel
042-742-8311
sugawara.rumi.rz@mail.hosp.go.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
| 2026 | Year | 08 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 04 | Month | 30 | Day |
Other
Other related information
Study Design:Observational study
Study Period:March 26, 2026 to March 31, 2028
Study Population:Patients aged 18 years or older with asthma or allergic bronchopulmonary mycosis (ABPM) who have persistent sputum symptoms and meet the inclusion and exclusion criteria.
Management information
Registered date
| 2026 | Year | 08 | Month | 01 | Day |
Last modified on
| 2026 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071453
