Molekule for Allergic Rhinitis/Asthma

NCT ID: NCT03627689

Last Updated: 2019-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-13

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Asthma Allergic Rhinitis Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active air purifier arm

Active portable air purifier for 1 month at bedside

Group Type EXPERIMENTAL

Active air purifier in respiratory allergies/asthma

Intervention Type OTHER

Continuous use of air purifier to improve allergies and asthma control

Sham air purifier arm

Placebo portable air purifier for 1 month at bedside

Group Type SHAM_COMPARATOR

Sham air purifier

Intervention Type OTHER

control arm

Interventions

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Active air purifier in respiratory allergies/asthma

Continuous use of air purifier to improve allergies and asthma control

Intervention Type OTHER

Sham air purifier

control arm

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Molekule

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nikhil G Rao, MD

Role: PRINCIPAL_INVESTIGATOR

Molekule

Locations

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Molekule

San Francisco, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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Molekule-052018

Identifier Type: -

Identifier Source: org_study_id

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