UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042840 |
|---|---|
| Receipt number | R000048862 |
| Scientific Title | Special Drug Use-Results Survey for ACTAIR Sublingual Tablets (Long-term Use) |
| Date of disclosure of the study information | 2020/12/24 |
| Last modified on | 2023/02/01 16:54:40 |
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Basic information
Public title
Special Drug Use-Results Survey for ACTAIR Sublingual Tablets (Long-term Use)
Acronym
Special Drug Use-Results Survey for ACTAIR Sublingual Tablets (Long-term Use)
Scientific Title
Special Drug Use-Results Survey for ACTAIR Sublingual Tablets (Long-term Use)
Scientific Title:Acronym
Special Drug Use-Results Survey for ACTAIR Sublingual Tablets (Long-term Use)
Region
| Japan |
Condition
Condition
Allergic rhinitis due to house dust mites
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and the efficacy at long-term use of ACTAIR
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse events at long-term use (up to 4 years)
Key secondary outcomes
Assessment of severity of allergic rhinitis (at enrollment, 6 months later, 1 year later, 2 years later, 3 years later, 4 years later and at discontinuation) and patients' global evaluation (6 months later, 1 year later, 2 years later, 3 years later, 4 years later, at discontinuation and 1 year after discontinuation) at long-term use (up to 4 years)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with allergic rhinitis due to house dust mites who administrate ACTAIR for the first time
Key exclusion criteria
NA
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Kaneto |
Organization
Shionogi & Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
541-0042
Address
3-13, Imabashi 3-Chome, Chuo-ku, Osaka 541-0042, Japan
TEL
+81-80-8522-9302
masako.kaneto@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Asaka |
Organization
Shionogi & Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
541-0042
Address
3-13, Imabashi 3-Chome, Chuo-ku, Osaka 541-0042, Japan
TEL
+81-70-7812-6812
Homepage URL
yuta.asaka@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
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
NA
Address
NA
Tel
NA
NA
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
| 2020 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
No URL
Publication of results
Published
Result
URL related to results and publications
No URL
Number of participants that the trial has enrolled
545
Results
Of 538 patients in the safety analysis set, 156 patients (29.00%) experienced an ADR. Of 383 patients in the effectiveness analysis set, rhinitis severity score change from baseline [mean(SD)] was -1.1(0.8) points at 6 months (n=258) and -2.1(1.0) points at 4 years (n=104). In addition, ratings on the PGI-I scale of >=80% of the patients increased.
Results date posted
| 2023 | Year | 02 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male was about 55%, and about two-thirds of patients were aged 15 to 64 years.
Participant flow
Of 545 patients CRFs were collected, 538 patients were included in the safety analysis set, and 383 patients were included in the effectiveness analysis set.
Adverse events
Major ADRs were 'oral pruritus' (3.72%) and 'throat irritation' (3.35%). No episodes of 'shock, anaphylaxis' were reported.
Outcome measures
- Incidence rates of ADRs
- Rhinitis severity score
- Patient global impression of improvement scale (PGI-I scale)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Approval by IRB is not necessary.
Management information
Registered date
| 2020 | Year | 12 | Month | 24 | Day |
Last modified on
| 2023 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048862
