Back to resultsMolekule for Allergic Rhinitis/Asthma
Primary Purpose
Asthma, Allergic Rhinitis, Allergic Conjunctivitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active air purifier in respiratory allergies/asthma
Sham air purifier
Sponsored by
About this trial
This is an interventional prevention trial for Asthma focused on measuring asthma, environmental intervention, allergies, air purifier
Eligibility Criteria
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
Sites / Locations
- Molekule
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active air purifier arm
Sham air purifier arm
Arm Description
Active portable air purifier for 1 month at bedside
Placebo portable air purifier for 1 month at bedside
Outcomes
Primary Outcome Measures
Control of Allergic Rhinitis and Asthma Test (CARAT) score
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03627689
Brief Title
Molekule for Allergic Rhinitis/Asthma
Official Title
Molekule for Allergic Rhinitis/Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Poor accural
Study Start Date
July 13, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molekule
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Allergic Rhinitis, Allergic Conjunctivitis
Keywords
asthma, environmental intervention, allergies, air purifier
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active air purifier arm
Arm Type
Experimental
Arm Description
Active portable air purifier for 1 month at bedside
Arm Title
Sham air purifier arm
Arm Type
Sham Comparator
Arm Description
Placebo portable air purifier for 1 month at bedside
Intervention Type
Other
Intervention Name(s)
Active air purifier in respiratory allergies/asthma
Intervention Description
Continuous use of air purifier to improve allergies and asthma control
Intervention Type
Other
Intervention Name(s)
Sham air purifier
Intervention Description
control arm
Primary Outcome Measure Information:
Title
Control of Allergic Rhinitis and Asthma Test (CARAT) score
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikhil G Rao, MD
Organizational Affiliation
Molekule
Official's Role
Principal Investigator
Facility Information:
Facility Name
Molekule
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Molekule for Allergic Rhinitis/Asthma
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