Molekule for Allergic Rhinitis/Asthma

Sponsor

Molekule (Industry)

Overall Status

Terminated

CT.gov ID

NCT03627689

Collaborator

(none)

Enrollment

Location

Arms

6.6

Actual Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma Allergic Rhinitis Allergic Conjunctivitis	Other: Active air purifier in respiratory allergies/asthma Other: Sham air purifier	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Molekule for Allergic Rhinitis/Asthma

Actual Study Start Date :

Jul 13, 2018

Actual Primary Completion Date :

Jan 31, 2019

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active air purifier arm Active portable air purifier for 1 month at bedside	Other: Active air purifier in respiratory allergies/asthma Continuous use of air purifier to improve allergies and asthma control
Sham Comparator: Sham air purifier arm Placebo portable air purifier for 1 month at bedside	Other: Sham air purifier control arm

Arm

Intervention/Treatment

Experimental: Active air purifier arm

Active portable air purifier for 1 month at bedside

Other: Active air purifier in respiratory allergies/asthma

Continuous use of air purifier to improve allergies and asthma control

Sham Comparator: Sham air purifier arm

Placebo portable air purifier for 1 month at bedside

Other: Sham air purifier

control arm

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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