Molekule for Allergic Rhinitis/Asthma

February 1, 2019 updated by: Molekule
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94103
        • Molekule

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Control of Allergic Rhinitis and Asthma Test (CARAT) score
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Molekule

Investigators

  • Principal Investigator: Nikhil G Rao, MD, Molekule

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

July 2, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 13, 2018

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Molekule-052018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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