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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

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 - BGF-VORTEX Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000061458
Enrollment
20
Registered
2026-05-06
Start date
2024-03-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic obstructive pulmonary disease

Interventions

None listed

Sponsors

Other
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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study If a patient develops influenza or a similar illness during the observation period the patient will be considered withdrawn however re enrollment is allowed if 4 weeks or more have passed after recovery and the eligibility criteria are met

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
CAT scores at baseline and at 4 weeks after spacer use.

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactSoichiro Hozawa

Hiroshima Allergy and Respiratory Clinic Hatchobori Chief Medical Director

hozawa@vesta.ocn.ne.jp082-511-5911

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026