UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025040 |
|---|---|
| Receipt number | R000028816 |
| Scientific Title | A randomized open-label positive-controlled crossover study of clinical efficacy of different type of inhaler devices for asthmatics with eosinophilic rhinosinusitis |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2024/06/10 16:40:20 |
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Basic information
Public title
A randomized open-label positive-controlled crossover study of clinical efficacy of different type of inhaler devices for asthmatics with eosinophilic rhinosinusitis
Acronym
Clinical efficacy of different type of inhaler devices for asthmatics with ECRS
Scientific Title
A randomized open-label positive-controlled crossover study of clinical efficacy of different type of inhaler devices for asthmatics with eosinophilic rhinosinusitis
Scientific Title:Acronym
Clinical efficacy of different type of inhaler devices for asthmatics with ECRS
Region
| Japan |
Condition
Condition
asthma with eosinophilic chronic rhinosinusitis
Classification by specialty
| Pneumology | Clinical immunology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy of different type of inhaler devices for asthmatics with eosinophilic chronic rhinosinusitis treated with inhaled corticosteroid exhalation through the nose
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Levels of fractionated exhaled nitrogen oxide 8 weeks after starting each trial drug administration
Key secondary outcomes
Lung function, nasal polyp score and sinus CT score 8 weeks after starting each trial drug administration
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
| Medicine |
Interventions/Control_1
Adair Discus 500 microgram one inhalation twice daily for 8 weeks, followed by Relvar Ellipta 200 microgram one inhalation once daily for 8 weeks
Interventions/Control_2
Relvar Ellipta 200 microgram one inhalation once daily for 8 weeks, followed by Adair Discus 500 microgram one inhalation twice daily for 8 weeks
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. patients with good asthma control under more than 8 weeks treatment with Adair Aerosol 250 microgram 2 inhalation twice daily though the nose
2. non-smoker
Key exclusion criteria
1. exacerbation within 4 weeks (eg. infection and asthma attack)
2. concomitant disease currently treated (eg. heart diseases, hematologic disorders, respiratory diseases)
3. pregnant patients
4. possibility of lack of examination security.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Kobayashi |
Organization
Kansai Medical University
Division name
Department of Otolaryngology, Neck and head surgery
Zip code
Address
2-5-1 Shinmachi, Hirakata, Osaka
TEL
072-804-0101
kobayosh@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Kobayashi |
Organization
Kansai Medical University
Division name
Department of Otolaryngology, Neck and head surgery
Zip code
Address
2-5-1 Shinmachi, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
kobayosh@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 01 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028816
