UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042690 |
|---|---|
| Receipt number | R000048718 |
| Scientific Title | The application of Budesonide/Formoterol turbuhaler with a tracker to improve asthma control in moderate to severe asthmatics: a randomized controlled study |
| Date of disclosure of the study information | 2020/12/10 |
| Last modified on | 2021/12/13 08:15:49 |
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Basic information
Public title
Using a tracker incorporated into Budesonide/Formoterol turbuhaler to improve asthma control: a randomized controlled study
Acronym
Turbuhaler tracker assisted asthma control
Scientific Title
The application of Budesonide/Formoterol turbuhaler with a tracker to improve asthma control in moderate to severe asthmatics: a randomized controlled study
Scientific Title:Acronym
BUD/FOR turbuhaler with a tracker to improve asthma control
Region
| Asia(except Japan) |
Condition
Condition
Patients with moderate to severe asthma with/without turbuhaler-incorporated tracker to assist asthma control
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the asthma control outcomes (changes of fractional exhaled nitric oxide [FeNO], scores of asthma control test [ACT], lung function parameters, acute exacerbation rates, ect.) treated with Budesonide/Formoterol turbuhaler in the presence or absence of Dubaobao tracker in patients with moderate to severe asthma
Basic objectives2
Others
Basic objectives -Others
To observe the dose and timing of controller inhaler use through the tracker-Dubaobao, and correlate the inhaler adherence recorded by the tracker with clinical outcomes
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment difference (post- minus pre-treatment) of FeNO between the tracker and usual care groups
Key secondary outcomes
Any one of the following conditions are estimated and regarded as secondary objectives: Changes from baseline on ACT score, FeNO, lung function, blood parameters within the same group; Treatment difference (post- minus pre-treatment) on ACT, lung function, blood parameters between the 2 groups; Electronic record of numbers and patterns of inhaler use; Correlation between inhaler use and asthma outcomes (symptoms worsening, any exacerbation, severe exacerbation); Annualized rate of severe exacerbations
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
| Other |
Interventions/Control_1
Budesonide/Formoterol tubuhaler with Dubaobao tracker (160/4.5 mcg per puff, 1 to 2 puffs twice daily plus as needed for 24 weeks)
Interventions/Control_2
Budesonide/Formoterol tubuhaler without Dubaobao tracker (160/4.5 mcg per puff, 1 to 2 puffs twice daily plus as needed for 24 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
Patients are considered eligible to enroll if they meet all of the following criteria: 1. Aged from 20 to 80 years. 2. Documented asthma history greater than 6 months before enrollment. 3. Patients who are in need of GINA step 3 to step 5 treatment at enrollment (on low to high dose inhale d corticosteroid/long-acting beta2 agonist with or without concurrent use of other asthma controllers, e.g. tiotropium, leukotriene receptor antagonist [LTRA] etc.). 4. Use of BUD/FOR for at least 4 weeks before enrollment.
Key exclusion criteria
Patients who meet any one of the following criteria will be excluded: 1. Hypersensitivity to BUD/FOR. 2. Had lower respiratory tract infections or received systemic steroid 4 weeks before enrollment. 3. Smoking history greater than 20 pack-years. 4. The onset of respiratory symptoms after the age of 40 years in current or previous smokers with a smoking history greater than 10 pack-years. 5. COPD, clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease. 6. A chest X-ray indicating diagnosis other than asthma that might interfere with the study. 7. Alcohol or medication abuse. 8. Pregnant woman. 9. Unable or unwilling to sign permit.
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Kang-Cheng |
| Middle name | |
| Last name | Su |
Organization
Taipei Veterans General Hospital
Division name
Department of Chest Medicine
Zip code
11217
Address
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan
TEL
+886-2-28712121-3152
kcsu@vghtpe.gov.tw
Public contact
Name of contact person
| 1st name | Kang-Cheng |
| Middle name | |
| Last name | Su |
Organization
Taipei Veterans General Hospital
Division name
Department of Chest Medicine
Zip code
11217
Address
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan
TEL
+886-2-28712121-3152
Homepage URL
kcsu@vghtpe.gov.tw
Sponsor or person
Institute
Taipei Veterans General Hospital
Institute
Department
Personal name
Funding Source
Organization
Taipei Veterans General Hospital
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Taiwan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Taipei Veterans General Hospital
Address
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan
Tel
+886-2-28757384
irbopinion@vghtpe.gov.tw
Secondary IDs
Secondary IDs
YES
Study ID_1
200620
Org. issuing International ID_1
2020-07-016B
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 | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 08 | Day |
Last modified on
| 2021 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048718
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