Molekule for Allergic Rhinitis/Asthma

Not Applicable

Terminated

• Conditions: Asthma; Allergic Rhinitis; Allergic Conjunctivitis
• Interventions: Other: Active air purifier in respiratory allergies/asthma; Other: Sham air purifier

• Registration Number: NCT03627689
• Lead Sponsor: Molekule

Brief Summary

Exposure to airborne allergens and pollutants is linked to symptom severity of allergies, asthma and other respiratory problems. In this study an air purifier using photo-electrochemical oxidation technology (PECO) will be used in the home environment of study participants. The investigator will assess the reduction of symptoms from allergic rhinitis/conjunctivitis and asthma.

Detailed Description

The purpose of this study is to assess the efficacy of the portable PECO air purifier in reducing symptoms from allergic rhinitis and asthma. Using a randomized, double blinded placebo, controlled trial we will be then able to assess if there are any changes after the use of the PECO air purifier after completing an initial baseline survey \& comparing to the exit survey. This is a double-blind study, which means that neither the participant nor the investigator knows which device is being used until after the trial is over.

Study Timeline

• Study First Submitted: 2018-07-02
• Study Start: 2018-07-13
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-13
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Chronic allergic rhinitis and/or conjunctivitis by history
2. History of adult asthma requiring medications now or in the past
3. Age ≥18
4. CARAT score less than 24

Exclusion Criteria

1. Participant is <18 years-old
2. Use of systemic corticosteroids within 14 days of study initiation
3. Treatment with biologic agents or allergen immunotherapy
4. Treatment with other immunomodulators (cyclosporine, azathioprine, hydroxychloroquine, etc)
5. Sensitive to fan sound or blue/purple light at night time

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active air purifier arm	Active air purifier in respiratory allergies/asthma	Active portable air purifier for 1 month at bedside
Sham air purifier arm	Sham air purifier	Placebo portable air purifier for 1 month at bedside

Primary Outcome Measures

Name	Time	Method
Control of Allergic Rhinitis and Asthma Test (CARAT) score	4 weeks	CARAT will measure the change in control scores of respiratory allergies and asthma.; Scale 0 (Worse control of allergy and asthma) to 30 (Best control of allergy and asthma). The higher score the better control of allergy and asthma.; There are 10 individual questions, scoring from 0-3.

Trial Locations

Locations (1)

Molekule; 🇺🇸 San Francisco, California, United States