Molekule for Allergic Rhinitis/Asthma

NCT03627689 | Terminated

• 1 other identifier: Molekule-052018
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Allergic Rhinitis; Allergic Conjunctivitis

Keywords

asthma; environmental intervention; allergies; air purifier

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Study Arms (2)

Active air purifier arm

EXPERIMENTAL

Active portable air purifier for 1 month at bedside

Other: Active air purifier in respiratory allergies/asthma

Sham air purifier arm

SHAM COMPARATOR

Placebo portable air purifier for 1 month at bedside

Other: Sham air purifier

Interventions

Active air purifier in respiratory allergies/asthma OTHER

Continuous use of air purifier to improve allergies and asthma control

Active air purifier arm

Sham air purifier OTHER

control arm

Sham air purifier arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Molekule: lead

Study Sites (1)

Molekule

San Francisco, California, 94103, United States

Location

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic; Conjunctivitis, Allergic; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Study Officials

• Nikhil G Rao, MD

  Molekule

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 13, 2018
• Study Start: July 13, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)