UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061458 |
|---|---|
| Receipt number | R000070326 |
| Scientific Title | A Prospective Observational Study on the Effect of Spacer (PARI Vortex) Use in Patients with Residual Symptoms Receiving Triple Inhalation Therapy with Budesonide/Glycopyrronium/Formoterol |
| Date of disclosure of the study information | 2026/05/06 |
| Last modified on | 2026/05/06 11:55:59 |
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Basic information
Public title
A Prospective Observational Study on the Effect of Spacer (PARI Vortex) Use in Patients with Residual Symptoms Receiving Triple Inhalation Therapy with Budesonide/Glycopyrronium/Formoterol
Acronym
BGF-VORTEX Study
Scientific Title
A Prospective Observational Study on the Effect of Spacer (PARI Vortex) Use in Patients with Residual Symptoms Receiving Triple Inhalation Therapy with Budesonide/Glycopyrronium/Formoterol
Scientific Title:Acronym
BGF-VORTEX Study
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of spacer use (PARI Vortex) will be evaluated in patients aged 40 years or older with COPD who have persistent symptoms despite triple inhalation therapy with budesonide/glycopyrronium/formoterol in routine clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CAT scores at baseline and at 4 weeks after spacer use.
Key secondary outcomes
1.Proportion of patients achieving the MCID in CAT score (2 or more point improvement)
2.Pulmonary function at baseline and at 4 weeks after spacer use (%FVC, %FEV1, FEF25-75)
3.IOS parameters at baseline and at 4 weeks after spacer use (R5, R20, X5, Fres)
4.Medication adherence at baseline and at 4 weeks after spacer use (ASK-12)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients diagnosed with COPD who have been receiving triple inhalation therapy with budesonide glycopyrronium formoterol in routine clinical practice for 4 weeks or longer
2.Patients with a COPD Assessment Test CAT score of 10 or higher
3.Adults aged 40 years or older
4.Patients who have provided written informed consent for participation in the study
If a patient develops influenza or a similar illness during the observation period the patient will be considered withdrawn however re enrollment is allowed if 4 weeks or more have passed after recovery and the eligibility criteria are met
Key exclusion criteria
1.Patients diagnosed with other respiratory diseases except for those with comorbid asthma
2.Patients with a history of allergy or hypersensitivity to inhaled medications
3.Patients who plan to participate in another study during the study participation period
4.Patients who have experienced an exacerbation within 4 weeks
5.Patients considered ineligible by the investigator due to impaired cognitive function or other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Soichiro |
| Middle name | |
| Last name | Hozawa |
Organization
Hiroshima Allergy and Respiratory Clinic Hatchobori
Division name
Chief Medical Director
Zip code
730-0013
Address
4F Hatchobori Miyata Building, 14-7 Hatchobori, Naka-ku, Hiroshima-shi, Hiroshima, Japan
TEL
082-511-5911
hozawa@vesta.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Hozawa |
Organization
Hiroshima Allergy and Respiratory Clinic Hatchobori
Division name
Chief Medical Director
Zip code
730-0013
Address
4F Hatchobori Miyata Building, 14-7 Hatchobori, Naka-ku, Hiroshima-shi, Hiroshima, Japan
TEL
082-511-5911
Homepage URL
hozawa@vesta.ocn.ne.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Soichiro Hozawa
Funding Source
Organization
None
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
Ethics Committee of the Medical Corporation HARG Hiroshima Allergy and Respiratory Clinic
Address
6F Daiichi Teraoka Building, 1-9-28 Hikarimachi, Higashi-ku, Hiroshima-shi, Hiroshima, Japan
Tel
082-568-1167
hozawa@vesta.ocn.ne.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
| 2026 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
20
Results
Enrolled 20 patients 16 eligible dropout 2 missing 2 CAT score significantly decreased by mean 8.56 at 4 weeks p less than 0.0001 MCID achievement 100 percent No significant change in percent FVC percent FEV1 IOS or adherence FEF25 decreased p equals 0.014 PARI Vortex improved symptoms in COPD on BGF suggesting enhanced drug delivery No clear lung function change possibly due to short duration longer use may provide further benefit Low cost and clinical utility supported
Results date posted
| 2026 | Year | 05 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age sex smoking status body mass index COPD severity pulmonary function percent FVC percent FEV1 IOS parameters CAT score and medication adherence ASK-12 at baseline were collected
Participant flow
Twenty patients were enrolled Sixteen patients were included in the analysis Two patients dropped out and two patients were excluded due to missing data
Adverse events
None
Outcome measures
Primary outcome
Change in CAT score from baseline to 4 weeks after spacer use
Secondary outcomes
Proportion of patients achieving MCID in CAT score 2 or more point improvement
Pulmonary function percent FVC percent FEV1 FEF25-75 at baseline and 4 weeks
IOS parameters R5 R20 X5 Fres at baseline and 4 weeks
Medication adherence ASK-12 at baseline and 4 weeks
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 05 | Month | 06 | Day |
Last modified on
| 2026 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070326
