UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062162 |
|---|---|
| Receipt number | R000071137 |
| Scientific Title | The Non-Blinded Study Comparing Oral Residual Fluticasone Levels After Inhalation of FP/FM-HFA with and without Spacer in Healthy Adults |
| Date of disclosure of the study information | 2026/07/07 |
| Last modified on | 2026/07/07 16:22:04 |
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Basic information
Public title
Comparative Study on the Amount of Steroid Residue in the Oral Cavity After Inhalation of Steroids With and Without Spacer Use
Acronym
CASROC Study(Comparative Amount of Steroid Residue in Oral Cavity Study)
Scientific Title
The Non-Blinded Study Comparing Oral Residual Fluticasone Levels After Inhalation of FP/FM-HFA with and without Spacer in Healthy Adults
Scientific Title:Acronym
CAFROC Study (Comparative Amount of Fluticasone Residue in Oral Cavity Study)
Region
| Japan |
Condition
Condition
No specific disease (Healthy Volunteers)
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to demonstrate that the use of a spacer (PARI Vortex) allows only the fine particles of inhaled corticosteroids to be inhaled, thereby reducing deposition in the oral cavity.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
oral residual levels of corticosteroids
Key secondary outcomes
residual levels of corticosteroids in the spacer and mouthpiece
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
inhalation of fluticasone
Interventions/Control_2
inhalation of fluticasone with the use of a spacer
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Generally healthy with no chronic diseases.
No abnormalities found in the health examination prior to the study.
Experience with inhaler use: no previous experience with inhalers or no use of inhalers for at least the past month.
Individuals who have received a thorough explanation of the study purpose, methods, risks,and benefits, and have provided written informed consent.
Key exclusion criteria
Individuals with a history of allergic reactions to inhaled drugs or their components.
Individuals currently receiving treatment for any chronic disease (e.g., hypertension, diabetes,heart disease).
Women who are pregnant or breastfeeding.
Individuals using medications during the study period that could affect the investigational drug or study procedures.
Individuals deemed medically unsuitable by the researcher.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takahiko |
| Middle name | |
| Last name | Horiguchi |
Organization
TOYOTA REGIONAL MEDICAL CENTER
Division name
Department of Respiratory Medicine and Allergy
Zip code
4710062
Address
3-30-1 Nishiyamacho, Toyota-shi, Aichi 471-0062, Japan
TEL
0565-34-3000
ta-hori@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Horiguchi |
Organization
TOYOTA REGIONAL MEDICAL CENTER
Division name
Department of Respiratory Medicine and Allergy
Zip code
4710062
Address
3-30-1 Nishiyamacho, Toyota-shi, Aichi 471-0062, Japan
TEL
0565-34-3000
Homepage URL
ta-hori@fujita-hu.ac.jp
Sponsor or person
Institute
TOYOTA REGIONAL MEDICAL CENTER,Department of Respiratory Medicine and Allergy,Takahiko Horiguchi
Institute
Department
Personal name
Takahiko Horiguchi
Funding Source
Organization
PARI Japan LLC
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
Toyota Regional Medical Center Institutional review board
Address
3-30-1 Nishiyamacho, Toyota-shi, Aichi 471-0062, Japan
Tel
565-34-3000
soumu@toyotachiiki-mc.or.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 | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
10
Results
The median amount of oral fluticasone residue after FP FM HFA inhalation using a pressurized metered dose inhaler alone was 129.5 micrograms range 31.9 to 234.0. When a valved holding chamber was used the median residue decreased to 26.3 micrograms range 1.9 to 40.9.
This represented an approximately 80 percent reduction in oral fluticasone residue. The difference was statistically significant with a p value less than 0.001
Results date posted
| 2026 | Year | 07 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adult men and women aged 20 years or older and younger than 65 years, with no chronic diseases, no abnormalities detected on a pre-study health examination, and no previous experience using inhalation devices or no use of inhalation devices within the past one month.
Participant flow
After obtaining written informed consent, participant eligibility will be assessed. Eligible participants who meet the inclusion criteria will be enrolled and undergo the inhalation test according to the study protocol. Following completion of the test, oral drug deposition will be measured, and the collected data will be analyzed to complete the study.
Adverse events
No adverse events were observed.
Outcome measures
oral residual levels of corticosteroids　　
residual levels of corticosteroids in the spacer and mouthpiece
Plan to share IPD
No plan to share individual participant data (IPD).
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 07 | Day |
Last modified on
| 2026 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071137
