Tokyo, April 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061192) titled 'Effects of HEPA filters in air purifiers on asthma control: A prospective, double-blind, multicenter, randomized clinical trial' on April 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Department of Advanced Medicine for Respiratory Failure, Graduate School of Medicine, Kyoto University
Condition:
Condition - asthma
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the relationship between asthma control and air quality in home environments by verifying the effectiveness of HEPA filters in air purifiers
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - (1) The group using air purifiers with HEPA filters
(2) Intervention period: 3 months
(3) Observation period: 1 month before the intervention period to assess indoor air quality without air purifiers
Interventions/Control_2 - (1) The group using air purifiers without HEPA filters
(2) Intervention period: 3 months
(3) Observation period: 1 month before the intervention period to assess indoor air quality without air purifiers
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - (1) Details of drug therapy are not restricted.
(2) One or more specific IgE antibodies must be positive.
Key exclusion criteria - (1) Patients cannot install air purifier at home because of this large size or other reasons.
(2) Patients with cognitive impairment.
(3) Patients with chronic pneumothorax.
(4) Patients with unstable conditions due to a new pneumothorax occurring within the past 4 weeks.
(5) Patients with unstable conditions due to asthma exacerbation or airway infection within the past 4 weeks.
(6) Patients with pre-existing plans to be away from home for 7 days or more during the observation and intervention periods.
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 08 Day
Anticipated trial start date - 2026 Year 09 Month 01 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069710
Disclaimer: Curated by HT Syndication.