UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056528 |
|---|---|
| Receipt number | R000064598 |
| Scientific Title | Changes in treatment effects before and after the introduction of ho inhalation for chronic respiratory diseases including bronchial asthma. |
| Date of disclosure of the study information | 2024/12/23 |
| Last modified on | 2025/01/23 20:28:39 |
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Basic information
Public title
Changes in treatment effects before and after the introduction of ho inhalation for chronic respiratory diseases including bronchial asthma.
Acronym
Changes in treatment effects before and after the introduction of ho inhalation for chronic respiratory diseases including bronchial asthma.
Scientific Title
Changes in treatment effects before and after the introduction of ho inhalation for chronic respiratory diseases including bronchial asthma.
Scientific Title:Acronym
Changes in treatment effects before and after the introduction of ho inhalation for chronic respiratory diseases including bronchial asthma.
Region
| Japan |
Condition
Condition
Chronic respiratory diseases including bronchial asthma.
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The therapeutic effects and side effects of inhalation will be evaluated, and it will be verified that the inhalation method is appropriate for treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fraction of exhaled nitric oxide(FeNO)
start of research, measurement taken 4 weeks after the start of research.
Key secondary outcomes
asthma control test
start of research, measurement taken 4 weeks after the start of research
hoarseness questionnaire
measurement taken 4 weeks after the start of research.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients diagnosed with chronic respiratory diseases, including bronchial asthma, will be assigned to two groups: Group A (standard inhalation method) and Group B (Hoo inhalation) after the target medication is initiated.
Eligible Drugs
fluticasone propionate ester formoterol fumarate hydrochloride hydrate inhalant (trade name: flutiform 125 aerosol 120 for inhalation)
butezonide, glycopyrronium bromide, formoterol fumarate hydrate inhalant (trade name: vireze triaerosphere 120 inhalation)
dosage and administration: 2 inhalations at a time, twice a day.
Interventions/Control_2
research week 0 fraction of exhaled nitric oxide(FeNo),asthma control test(ACT),inhalation instruction
research for 2 weeks inhalation instruction
research for 4 weeks fraction of exhaled nitric oxide(FeNo),asthma control test(ACT),inhalation,instruction,hoarseness questionnaire
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Those who have been diagnosed with chronic respiratory diseases, including bronchial asthma, and have started the target drug
2 FeNO 22ppb or more
3 18 years and older
4 Those who have obtained consent by explaining this research using explanatory document
Key exclusion criteria
1.Those judged to have insufficient understanding of inhalation.
2.Those judged to have difficulty mastering inhalation techniques.
3.Those deemed inappropriate for participation in this study by the principal investigator or co-investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mitsuki |
| Middle name | |
| Last name | Hino |
Organization
Nihon Medical University Respiratory Care Clinic
Division name
Pulmonology
Zip code
102-0074
Address
8th floor, JPR Ichigaya Building, 4-7-15 Kudanminami, Chiyoda-ku, Tokyo
TEL
03-5276-2325
hino@nms.ac.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Yoshikawa |
Organization
Nippon medical school hospital
Division name
pharmacy Department
Zip code
113-8603
Address
1-1-15 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
s-yoshikawa@nms.ac.jp
Sponsor or person
Institute
Nihon Medical University Respiratory Care Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Nippon Medical School Hospital
Address
1-1-15 Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
nms_fuzokurinri@nms.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
| 2024 | Year | 12 | Month | 23 | 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
| 2024 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 06 | 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 | 12 | Month | 21 | Day |
Last modified on
| 2025 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064598
