Molekule for Allergic Rhinitis/Asthma
Phase: NA
Conditions: Asthma, Allergic Rhinitis, Allergic Conjunctivitis
Sponsor: Molekule

Protocol Date June 21, 2018 
Study Protocol Title: 
Molekule for allergic rhinitis/asthma 
 
 
 

Molekule for allergic rhinitis/asthma  
Background:   
In the United States, the incidence of respiratory allergies and asthma are increasing, with 10-
40% of the population suffering from allergies 1 and 8% suffering from asthma2.  The direct and indirect 
health costs and decrement in quality of life from these illnesses are substantial2,3. While these 
symptoms are typically attributed to aeroallergens, there are particulate matter and volatile organic 
compounds (VOCs) that act as irritants that can also evoke symptoms. Local air filtration has shown 
some ability to decrease allergen counts in the air and thus improve the symptoms experienced by 
allergy and asthma sufferers under certain conditions4.  However, to date the efficacy of a 
comprehensive air purification system, particularly with high efficiency particulate air (HEPA) filtration, 
as a sole intervention modality has been equivocal and the extent of air filtration remains suboptimal.   
Photo-electrochemical oxidation (PECO) is a revolutionary new technology for providing an air 
purification solution.  In addition to physical filtration, a photo-electrochemical reaction takes place on 
the surface of a nano-coated filter leading to the oxidation of organic matter.  These processes allow for 
the destruction of organic material 1000 times smaller than what a HEPA filter can capture5,6.  Thus, 
PECO not only removes but can also efficiently destroy organic matter, bacteria, viruses, mold, and VOCs 
converting them into their trace elements 7. 
Specific Goals/Objectives: 
Primary Objective: To assess the efficacy of the portable Molekule air purifier in reducing 
symptoms from allergic rhinitis and asthma. 
Hypothesis: The portable Molekule air purifier will significantly improve allergy and asthma symptom 
scores in patients with allergic rhinitis and asthma. 
Study Design: 
• 
Randomized double blinded placebo, controlled trial for participants using the Molekule air 
purifier or placebo unit for a total of 4 weeks.  The portable unit will be placed at the 
participants bedside and will be running continuously.  Screening survey for eligibility will take 
place and unit will be shipped and ready for use within 1 week.  Device use will take place for 4 
weeks and then there will be an exit survey.  Primary endpoint is change in CARAT scores.  Unit 
should be running >18 hours per day including at night time in the participant bedroom  
Patient Selection:   
 
Inclusion Criteria: 
• 
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  
 
Exclusion Criteria: 
• 
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) 
 

Study Endpoints   
 
Primary Endpoints: 
• 
CARAT scores (see survey below) 
 
Secondary Endpoints/exploratory: 
• 
Upper airway scores per CARAT 
• 
Lower airway scores per CARAT  
• 
Change in allergy medication use 
• 
Change in asthma medication use 
• 
Asthma exacerbations requiring clinic or ER visits  
• 
Compliance of air purifier use  
Statistical Analysis:  
A sample size of 110 subjects, 55 in each arm, is sufficient to detect a clinically important difference of 
3.5 between groups assuming a standard deviation of 6.43 using a two-tailed t-test of difference 
between means with 80% power and a 5% level of significance.   
SigmaStat 4.0 
 
Reference: Sakpal TV. Sample Size Estimation in Clinical Trial. Perspectives in Clinical Research. 
2010;1(2):67-69. 
Software: SigmaStat V4.0 
Additional items: 
1)Obtain IRB approval-2-4 weeks 
2)Manufacture placebo and active units-8 weeks (I am estimating that we will be able to have 
approximately 60 units (30 + 30) made for this purpose)  
3)Screen participants from Molekule mailing list, begin enrollment and ship units   
4)Those randomized to placebo will be contacted at the conclusion of the study and will be able to test 
the units (data not planned to be collected) 
References: 
1. 
Settipane RA. Demographics and epidemiology of allergic and nonallergic rhinitis. Allergy 
Asthma Proc. 2001;22(4):185-189. 
2. 
Loftus PA, Wise SK. Epidemiology and economic burden of asthma. Int Forum Allergy Rhinol. 
2015;5 Suppl 1:S7-10. 
3. 
Schoenwetter WF, Dupclay L, Jr., Appajosyula S, Botteman MF, Pashos CL. Economic impact and 
quality-of-life burden of allergic rhinitis. Curr Med Res Opin. 2004;20(3):305-317. 
4. 
Sublett JL. Effectiveness of air filters and air cleaners in allergic respiratory diseases: a review of 
the recent literature. Curr Allergy Asthma Rep. 2011;11(5):395-402. 
5. 
Goswami DY. Decontamination of ventilation systems using photocatalytic air cleaning 
technology. TRANSACTIONS-AMERICAN SOCIETY OF MECHANICAL ENGINEERS JOURNAL OF 
SOLAR ENERGY ENGINEERING. 2003;125(3):359-365. 
6. 
Zhang Y, Stefanakos EK, Goswami DY. Effect of photocatalytic surface roughness on reactors 
effectiveness for indoor air cleaning. Building and Environment. 2013;61:188-196. 

7. 
Dalrymple OK, Stefanakos E, Trotz MA, Goswami DY. A review of the mechanisms and modeling 
of photocatalytic disinfection. Applied Catalysis B: Environmental. 2010;98(1):27-38.