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Molekule for Allergic Rhinitis/Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627689
Recruitment Status : Terminated (Poor accural)
First Posted : August 13, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Asthma Allergic Rhinitis Allergic Conjunctivitis Other: Active air purifier in respiratory allergies/asthma Other: Sham air purifier Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 13, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Asthma

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




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627689


Locations
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United States, California
Molekule
San Francisco, California, United States, 94103
Sponsors and Collaborators
Molekule
Investigators
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Principal Investigator: Nikhil G Rao, MD Molekule
  Study Documents (Full-Text)

Documents provided by Molekule:
Study Protocol  [PDF] June 21, 2018

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Responsible Party: Molekule
ClinicalTrials.gov Identifier: NCT03627689    
Other Study ID Numbers: Molekule-052018
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Molekule:
asthma
environmental intervention
allergies
air purifier
Additional relevant MeSH terms:
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Asthma
Rhinitis
Rhinitis, Allergic
Conjunctivitis
Conjunctivitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Conjunctival Diseases
Eye Diseases