UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055047 |
|---|---|
| Receipt number | R000062731 |
| Scientific Title | Evaluation of the Efficacy of Topical Steroid Spray Therapy in Recurrent Chronic Rhinosinusitis |
| Date of disclosure of the study information | 2024/07/24 |
| Last modified on | 2024/07/23 10:01:56 |
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Basic information
Public title
Evaluation of the Efficacy of Topical Steroid Spray Therapy in Recurrent Chronic Rhinosinusitis
Acronym
Efficacy of Topical Steroid Spray in Recurrent Chronic Rhinosinusitis
Scientific Title
Evaluation of the Efficacy of Topical Steroid Spray Therapy in Recurrent Chronic Rhinosinusitis
Scientific Title:Acronym
Efficacy of Topical Steroid Spray in Recurrent Chronic Rhinosinusitis
Region
| Japan |
Condition
Condition
Chronic rhinosinusitis with nasal polyps
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to compare the steroids spraying technique using a flexible endoscope through a scope channel and using an otolaryngologic catheter under rigid endoscopy for recurrent cases after endoscopic sinus surgery in patients with chronic rhinosinusitis with nasal polyps, including eosinophilic chronic rhinosinusitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in edematous lesions of the sinonasal mucosa according to endoscopic findings before the treatment and one month after the treatment in the spraying of steroids through an otolaryngological catheter under the observation of a rigid endoscope or through a scope channel using a flexible endoscope.
Key secondary outcomes
Changes in CT findings before and one month after treatment
Availability of steroid sprays and difficulty of accessing the spray catheter to the treatment area
Changes in scores and percentages on the symptom questionnaire and the patient tolerance questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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 drug spraying using a flexible endoscope through a treatment channel group, the doctor inserts the flexible endoscope with a treatment channel into the sinus cavity to be treated, confirms the treatment site, inserts the spraying catheter into the flexible endoscope's treatment channel, and sprays the drug with a syringe attached to the spraying catheter.
Interventions/Control_2
In drug spraying using a rigid endoscope through an otorhinolaryngologic catheter group, the doctor inserts the rigid endoscope into the sinus cavity to be treated, confirms the treatment site, inserts the spraying catheter into the otorhinolaryngologic catheter, and sprays the drug with a syringe attached to the spraying catheter.
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
Patients over 18 years of age.
Patients diagnosed with chronic rhinosinusitis with nasal polyp.
Patients with a history of endoscopic sinus surgery and postoperative recurrence despite saline lavage of the sinuses and continuous nasal steroid spray treatment.
Patients who have received a thorough explanation of their participation in this study and have given written consent of their own free will based on a thorough understanding.
Key exclusion criteria
Patients with allergy or intolerance to steroids.
Patients with comorbid conditions require chemotherapy, immunotherapy, or oral steroids.
Patients with clinical evidence of acute bacterial sinusitis, invasive fungal sinusitis, or diabetes mellitus.
Patients with a history or diagnosis of glaucoma, ocular hypertension, or cataracts.
Other patients were deemed inappropriate by the physician.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Haruna |
Organization
Dokkyo Medical University Hospital
Division name
Otorhinolaryngology and Head & Neck Surgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL
0282-87-2164
haruna@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Tsuguhisa |
| Middle name | |
| Last name | Nakayama |
Organization
Dokkyo Medical University Hospital
Division name
Otorhinolaryngology and Head & Neck Surgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL
0287-87-2164
Homepage URL
t-nakayama855@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
KEIHOKAI, Medical Corporation, MATSUWAKI CLINIC Shinagawa
OLYMPUS MEDICAL SYSTEMS CORPORATION
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board, Dokkyo Medical Universith Hospital
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
Tel
0282-87-2275
r-kenkyu@dokkyomed.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 | 07 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | 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 | 07 | Month | 23 | Day |
Last modified on
| 2024 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062731
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