Molekule for Allergic Rhinitis/Asthma

Asthma Clinical Trial

Official title:

Molekule for Allergic Rhinitis/Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03627689
• Other study ID #: Molekule-052018
• Status: Terminated
• Phase: N/A
• Start date: July 13, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: February 2019
• Source: Molekule
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Allergic Rhinitis
• Asthma
• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• Active air purifier in respiratory allergies/asthma
Continuous use of air purifier to improve allergies and asthma control
• Sham air purifier
control arm

Locations

Country	Name	City	State
United States	Molekule	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Molekule

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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