Tokyo, May 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061458) titled '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' on May 6.
Study Type:
Observational
Primary Sponsor:
Institute - Other
Condition:
Condition - chronic obstructive pulmonary disease
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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If a patient develops influenza or a similar illness during the observation period the patient will be considered withdrawn however re enrollment is allowed if 4 weeks or more have passed after recovery and the eligibility criteria are met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 Size - 20
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070326
Disclaimer: Curated by HT Syndication.
