UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049879 |
|---|---|
| Receipt number | R000056810 |
| Scientific Title | Efficacy, equivalence and operability of switching to a combination of budesonide, glycopyrronium, and formoterol in patients with COPD and ACO |
| Date of disclosure of the study information | 2022/12/23 |
| Last modified on | 2022/12/23 02:09:26 |
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Basic information
Public title
Efficacy, equivalence and operability of switching to a combination of budesonide, glycopyrronium, and formoterol in patients with COPD and ACO
Acronym
Efficacy, equivalence and operability of switching to a combination of budesonide, glycopyrronium, and formoterol in patients with COPD and ACO
Scientific Title
Efficacy, equivalence and operability of switching to a combination of budesonide, glycopyrronium, and formoterol in patients with COPD and ACO
Scientific Title:Acronym
Efficacy, equivalence and operability of switching to a combination of budesonide, glycopyrronium, and formoterol in patients with COPD and ACO
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An observational study of efficacy, adverse events, inhalation maneuverability, and adherence before and after switching to Breztri (a combination of budesonide, glycopyrronium, and formoterol) in patients with COPD or ACO requiring an corticosteroid, long-acting beta 2 agonist, and long-acting muscarinic antagonist.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Efficacy, adverse events, inhalation maneuverability, and adherence before and after switching to Breztri (a combination of budesonide, glycopyrronium, and formoterol) in patients with COPD or ACO requiring an ICS, LABA, and LAMA.
Key secondary outcomes
Comparison with Trelegy in patients switching from Trelegy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Breztri for patients requiring ICS, LABA, or LAMA
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
COPD or ACO patients requiring ICS, LABA and LAMA
Patients who can give consent
Key exclusion criteria
1) Under 40 years old
2) Patients who have difficulty inhaling by theirself
3) Patients for whom the physician determines that pulmonary function testing is impossible or inaccurate for any reason (e.g., hearing loss, pregnancy, etc.)
4) Patients whose QoL or lung function may be affected during the study period, as determined by the physician: e.g., patients with end-stage cancer, severe heart failure, liver cirrhosis, respiratory failure, etc.
5) Patients who cannot use ICS or LABA or LAMA
Target sample size
70
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
https://www.med.kindai.ac.jp/nara/
muraki-m@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Nara Hospital
Institute
Department
Personal name
Masato Muraki
Funding Source
Organization
Kindai University Nara Hospital
Organization
Division
Category of Funding Organization
Other
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
近畿大学奈良病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 23 | 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
| 2020 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 07 | 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 | 12 | Month | 23 | Day |
Last modified on
| 2022 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056810
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
