UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048327 |
|---|---|
| Receipt number | R000055079 |
| Scientific Title | Comparison of Enerziar and Trelegy, Single inhaler triple therapy (SITT), in asthma (2) |
| Date of disclosure of the study information | 2022/07/09 |
| Last modified on | 2022/07/09 03:11:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of Enerziar and Trelegy, Single inhaler triple therapy (SITT), in asthma (2)
Acronym
Comparison of Enerziar and Trelegy, Single inhaler triple therapy (SITT), in asthma (2)
Scientific Title
Comparison of Enerziar and Trelegy, Single inhaler triple therapy (SITT), in asthma (2)
Scientific Title:Acronym
Comparison of Enerziar and Trelegy, Single inhaler triple therapy (SITT), in asthma (2)
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
a prospective randomized crossover study of middle-dose Enerzair and Trelegy 100 in adult patients with moderate asthma. We will compare the efficacy and adverse events of each medications.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL scores and forced expiratory volume in 1 second. Background factors of medication selected as better.
Key secondary outcomes
Various pulmonary function test items, FeNO levels, and frequency of adverse events.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
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
Enerzair
Interventions/Control_2
Trelegy
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
Adult asthma patients aged 18 years or older with moderate asthma
Key exclusion criteria
1) Patients who have difficulty inhaling by themself
2) Patients who are unable to perform lung function tests
3) For example, patients with end-stage cancer, severe heart failure, liver cirrhosis, respiratory failure, etc.
4) Current smokers, pregnant women, under 17 years old
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Muraki |
Organization
Kindai University Nara Hospital
Division name
Department of Respiratory Medicine and Allergology
Zip code
630-0293
Address
1248-1 Otoda-cho, Ikoma, Nara 630-0293, Japan
TEL
0743-77-0880
muraki-m@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Muraki |
Organization
Kindai University Nara Hospital
Division name
Department of Respiratory Medicine and Allergology
Zip code
630-0293
Address
1248-1 Otoda-cho, Ikoma, Nara 630-0293, Japan
TEL
0743-77-0880
Homepage URL
muraki-m@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Kindai University
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
Kindai University Nara Hospital
Address
1248-1 Otoda-cho, Ikoma, Nara 630-0293, Japan
Tel
0743-77-0880
muraki-m@med.kindai.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
| 2022 | Year | 07 | Month | 09 | 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
| 2022 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 07 | Month | 09 | Day |
Last modified on
| 2022 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055079
