AsthmaNCT03627689
Molekule for Allergic Rhinitis/Asthma
A study testing Active air purifier in respiratory allergies/asthma in people with Asthma and Allergic Rhinitis, run by Molekule at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Allergic Rhinitis, Allergic Conjunctivitis
- What is being tested?
- Active air purifier in respiratory allergies/asthma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2018to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Asthma, Allergic Rhinitis, Allergic Conjunctivitis
- Being tested
- Active air purifier in respiratory allergies/asthma, Sham air purifier
- Keywords
- asthma, environmental intervention, allergies, air purifier
- Medical subject headings
- Asthma, Rhinitis, Allergic, Conjunctivitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active air purifier in respiratory allergies/asthmaOther
Continuous use of air purifier to improve allergies and asthma control
Sham air purifierOther
control arm
| Study group | Role | What they receive |
|---|---|---|
| Active air purifier arm | Experimental | Active portable air purifier for 1 month at bedside Receives: Other: Active air purifier in respiratory allergies/asthma |
| Sham air purifier arm | Sham comparator | Placebo portable air purifier for 1 month at bedside Receives: Other: Sham air purifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start13 Jul 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Why it stopped: Poor accural
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molekule
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nikhil G Rao, MD, Principal investigator, Molekule
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627689
- Sponsor's protocol ID
- Molekule-052018
- Status last verified
- Feb 2019
- First submitted
- 2 Jul 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molekule for Allergic Rhinitis/Asthma
- ClinicalTrials.gov ID
- NCT03627689
- Acronym / sponsor ID
- Molekule-052018
- Conditions
- Asthma, Allergic Rhinitis, Allergic Conjunctivitis
- Keywords
- asthma, environmental intervention, allergies, air purifier
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accural
- Enrolment
- 49 participants (actual)
- Lead sponsor
- MolekuleIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active air purifier arm | Experimental | Other: Active air purifier in respiratory allergies/asthmaActive portable air purifier for 1 month at bedside |
| Sham air purifier arm | Sham comparator | Other: Sham air purifierPlacebo portable air purifier for 1 month at bedside |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active air purifier in respiratory allergies/asthmaContinuous use of air purifier to improve allergies and asthma control | Other | Active air purifier arm |
| Sham air purifiercontrol arm | Other | Sham air purifier arm |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Poor accural). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikhil G Rao, MD principal investigator
Molekule
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active air purifier in respiratory allergies/asthma in people with Asthma and Allergic Rhinitis, run by Molekule at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor accural). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of Allergic Rhinitis and Asthma Test (CARAT) score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019; AzTrials last refreshed its copy on 28 Oct 2026.