Clinical Trial: The Non-Blinded Study Comparing Oral Residual Fluticasone Levels After Inhalation of FP/FM-HFA with and without Spacer in Healthy Adults (Japan)

Tokyo, July 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062162) titled 'Comparative Study on the Amount of Steroid Residue in the Oral Cavity After Inhalation of Steroids With and Without Spacer Use' on July 7.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - TOYOTA REGIONAL MEDICAL CENTER,Department of Respiratory Medicine and Allergy,Takahiko Horiguchi

Condition: Condition - No specific disease (Healthy Volunteers) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim is to demonstrate that the use of a spacer (PARI Vortex) allows only the fine particles of inhaled corticosteroids to be inhaled, thereby reducing deposition in the oral cavity. Basic objectives2 - Bio-availability

Intervention: Interventions/Control_1 - inhalation of fluticasone Interventions/Control_2 - inhalation of fluticasone with the use of a spacer

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Generally healthy with no chronic diseases. No abnormalities found in the health examination prior to the study. Experience with inhaler use: no previous experience with inhalers or no use of inhalers for at least the past month. Individuals who have received a thorough explanation of the study purpose, methods, risks,and benefits, and have provided written informed consent. Key exclusion criteria - Individuals with a history of allergic reactions to inhaled drugs or their components. Individuals currently receiving treatment for any chronic disease (e.g., hypertension, diabetes,heart disease). Women who are pregnant or breastfeeding. Individuals using medications during the study period that could affect the investigational drug or study procedures. Individuals deemed medically unsuitable by the researcher. Target Size - 10

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 10 Month 09 Day Date of IRB - 2024 Year 11 Month 26 Day Anticipated trial start date - 2025 Year 01 Month 29 Day Last follow-up date - 2025 Year 06 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071137

Disclaimer: Curated by HT Syndication.