Healthy AdultsNCT07887958
Feasibility, Acceptability, and Safety of a Drug-Free Nasal Spray in Frontline Healthcare Workers
A study testing Nasal Spray in people with Healthy Adults, run by Akita Biosciences, Inc. at 1 site in United States.
Trial summary
This study looked at whether frontline healthcare workers could use a drug-free nasal spray twice a day for 8 weeks, whether it was safe, and whether they found it acceptable. The spray used in the study (Profi Nasal Spray, Akita Biosciences) was a cosmetic nasal hygiene product made from ingredients already used in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Nasal Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2025to 30 Jun 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare workers employed at the study hospital
- Age 18 years or older
- Able and willing to provide written informed consent
Who cannot join
- Upper respiratory infection within 7 days before enrollment
- Diagnosis of COVID-19, RSV, or influenza within 7 days before enrollment
- History of nasal disorders, allergic rhinitis, asthma, chronic obstructive pulmonary disease (COPD), or other ear, nose, and throat disorders
- Daily use of other nasal sprays
- Nasal mucosal erosion, nasal ulceration, or nasal septal perforation
- Autoimmune disorder
Show all 9Show fewer
- History of hypersensitivity, allergy, or anaphylactic reactions
- Pregnant, breastfeeding, or attempting to become pregnant
- Currently taking medication that may affect nasal symptoms or respiratory infection (e.g., nasal decongestants or immunosuppressants)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Evaluate Feasibility, Acceptability, and Safety of a Nasal Spray Among Health Care Workers
This study looked at whether frontline healthcare workers could use a drug-free nasal spray twice a day for 8 weeks, whether it was safe, and whether they found it acceptable.
The spray used in the study (Profi Nasal Spray, Akita Biosciences) was a cosmetic nasal hygiene product made from ingredients already used in nasal and topical products.
Read more
Healthcare workers at a public hospital in New York City were randomly assigned to use the spray twice a day for 8 weeks or to receive no spray. The study asked:
- Feasibility: Could busy healthcare workers use the spray as directed over 8 weeks?
- Safety: Were side effects more common in people who used the spray than in people who did not?
- Acceptability: How did users feel about the spray, and did they stay in the study?
Every 3 days, participants answered a short online questionnaire about spray use, side effects, respiratory symptoms, and contact with patients who had COVID-19, influenza, or RSV. Spray use was checked by weighing the bottles at weeks 4 and 8.
To better understand acceptability, about 20 spray users also took part in one-on-one interviews about what it was like to use the spray, including ease of use, fitting it into a daily routine, and anything that made it harder to use.
Read the detailed description
This was a single-center, open-label, randomized, mixed-methods pilot study of frontline healthcare workers at a public hospital in New York City, conducted during a period of high community activity of influenza, RSV, and COVID-19. Participants were randomized 1:1 to use Profi Nasal Spray twice daily for 8 weeks or to receive no spray. Research staff demonstrated how to use the spray.
Intervention participants received one bottle (about 4 weeks of supply) at enrollment and a second bottle at an in-person visit at week 4. Remaining spray was weighed at weeks 4 and 8 to measure adherence. All participants were reminded about hand hygiene and asked to follow hospital guidance on masks and personal protective equipment.
Every 3 days, all participants completed a short online questionnaire covering spray use, ease of use, scent, stinging or burning and other side effects, contact with patients with confirmed COVID-19, influenza, or RSV, and fever or respiratory symptoms in the past 24 hours. Participants who reported a side effect, an exposure, or new symptoms completed a detailed daily symptom questionnaire until symptoms resolved, and study staff contacted them daily. Participants with symptoms of a respiratory infection were encouraged to be tested for COVID-19, influenza, and RSV at the hospital.
Adverse events were reviewed by a data monitoring team. If spray use stopped for more than 72 hours, participants were followed for adverse events 30 days after the last dose. Respiratory symptoms were monitored in both groups as an additional safety measure.
A subset of intervention participants, selected to represent a range of adherence, side effects, and symptom experiences, completed semi-structured one-on-one interviews about ease of use, adherence, acceptability, and barriers to use. Interviews were audio-recorded, transcribed, and independently coded by two trained researchers using thematic analysis. Coders resolved differences by discussion and consensus.
- Conditions
- Healthy Adults
- Being tested
- Nasal Spray
- Keywords
- Nasal Spray, Healthcare Workers, Feasibility Studies, Safety, Acceptability, Patient Acceptance of Health Care
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal SprayOther
Also called Profi Nasal Spray, PCANS (Pathogen Capture and Neutralizing Spray)
Profi Nasal Spray (Akita Biosciences) is a drug-free nasal spray that forms a thin coating in the nose to help trap and clear airborne particles. It is made from ingredients already used in commercially available nasal and topical products.
| Study group | Role | What they receive |
|---|---|---|
| Nasal Spray Arm | Experimental | Participants used the nasal spray, one spray in each nostril twice daily, for 8 weeks. Participants received one bottle (about 4 weeks of supply) at enrollment and a second bottle at week 4. Remaining spray was weighed at weeks 4 and 8 to measure adherence. Receives: Other: Nasal Spray |
| No Spray (Control) | No intervention | Participants did not receive a nasal spray. They completed the same questionnaires and study visits as the spray group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using the nasal spray
Number of eligible healthcare workers who consented and enrolled in the study and continued to use the nasal spray.
Measured: 8 weeks
Safety: Number of Participants With Adverse Events
Adverse events in the intervention and control groups, including new nasal discomfort or irritation, stinging or burning, changes in smell or taste, nosebleeds, and respiratory events, with duration and severity.
Measured: 12 weeks
Acceptability: Adherence to Daily Use and Study Dropout
Adherence: proportion of intervention participants with less than 20% of the expected amount of spray remaining in the bottle (by weight), indicating use of more than 80% of expected doses. Dropout: proportion of participants in each group who withdrew or were lost to follow-up.
Measured: Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start26 Feb 2025
- Primary completion30 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized 1:1 to use the nasal spray twice daily for 8 weeks or to receive no spray (untreated control).
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akita Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New York City Health and Hospitals Corporation
- Responsible party
- Sponsor
- Investigators
- Vidya Menon, MD, Principal investigator, New York City Health and Hospitals Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887958
- Sponsor's protocol ID
- AKITA-NYCHH-2025-01
- Other IDs
- 23-02-231-134(HHC)
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data publicly available. De-identified data may be shared by the study investigators upon reasonable request.
Publications
Joseph J, Baby HM, Quintero JR, Kenney D, Mebratu YA, Bhatia E, Shah P, Swain K, Lee D, Kaur S, Li XL, Mwangi J, Snapper O, Nair R, Agus E, Ranganathan S, Kage J, Gao J, Luo JN, Yu A, Park D, Douam F, Tesfaigzi Y, Karp JM, Joshi N. Toward a Radically Simple Multi-Modal Nasal Spray for Preventing Respiratory Infections. Adv Mater. 2024 Nov;36(46):e2406348. doi: 10.1002/adma.202406348. Epub 2024 Sep 24.
PubMed 39318086
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Feasibility, Acceptability, and Safety of a Nasal Spray Among Health Care Workers
- ClinicalTrials.gov ID
- NCT07887958
- Acronym / sponsor ID
- AKITA-NYCHH-2025-01
- Conditions
- Healthy Adults
- Keywords
- Nasal Spray, Healthcare Workers, Feasibility Studies, Safety, Acceptability, Patient Acceptance of Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Akita Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- New York City Health and Hospitals Corporation
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 22 Oct 2026 (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.
This study looked at whether frontline healthcare workers could use a drug-free nasal spray twice a day for 8 weeks, whether it was safe, and whether they found it acceptable.
The spray used in the study (Profi Nasal Spray, Akita Biosciences) was a cosmetic nasal hygiene product made from ingredients already used in nasal and topical products.
Healthcare workers at a public hospital in New York City were randomly assigned to use the spray twice a day for 8 weeks or to receive no spray. The study asked:
- Feasibility: Could busy healthcare workers use the spray as directed over 8 weeks?
- Safety: Were side effects more common in people who used the spray than in people who did not?
- Acceptability: How did users feel about the spray, and did they stay in the study?
Every 3 days, participants answered a short online questionnaire about spray use, side effects, respiratory symptoms, and contact with patients who had COVID-19, influenza, or RSV. Spray use was checked by weighing the bottles at weeks 4 and 8.
To better understand acceptability, about 20 spray users also took part in one-on-one interviews about what it was like to use the spray, including ease of use, fitting it into a daily routine, and anything that made it harder to use.
Detailed description
This was a single-center, open-label, randomized, mixed-methods pilot study of frontline healthcare workers at a public hospital in New York City, conducted during a period of high community activity of influenza, RSV, and COVID-19. Participants were randomized 1:1 to use Profi Nasal Spray twice daily for 8 weeks or to receive no spray. Research staff demonstrated how to use the spray.
Intervention participants received one bottle (about 4 weeks of supply) at enrollment and a second bottle at an in-person visit at week 4. Remaining spray was weighed at weeks 4 and 8 to measure adherence. All participants were reminded about hand hygiene and asked to follow hospital guidance on masks and personal protective equipment.
Every 3 days, all participants completed a short online questionnaire covering spray use, ease of use, scent, stinging or burning and other side effects, contact with patients with confirmed COVID-19, influenza, or RSV, and fever or respiratory symptoms in the past 24 hours. Participants who reported a side effect, an exposure, or new symptoms completed a detailed daily symptom questionnaire until symptoms resolved, and study staff contacted them daily. Participants with symptoms of a respiratory infection were encouraged to be tested for COVID-19, influenza, and RSV at the hospital.
Adverse events were reviewed by a data monitoring team. If spray use stopped for more than 72 hours, participants were followed for adverse events 30 days after the last dose. Respiratory symptoms were monitored in both groups as an additional safety measure.
A subset of intervention participants, selected to represent a range of adherence, side effects, and symptom experiences, completed semi-structured one-on-one interviews about ease of use, adherence, acceptability, and barriers to use. Interviews were audio-recorded, transcribed, and independently coded by two trained researchers using thematic analysis. Coders resolved differences by discussion and consensus.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized 1:1 to use the nasal spray twice daily for 8 weeks or to receive no spray (untreated control).
| Arm | Type | Receives |
|---|---|---|
| Nasal Spray Arm | Experimental | Other: Nasal SprayParticipants used the nasal spray, one spray in each nostril twice daily, for 8 weeks. Participants received one bottle (about 4 weeks of supply) at enrollment and a second bottle at week 4. Remaining spray was weighed at weeks 4 and 8 to measure adherence. |
| No Spray (Control) | No intervention | –Participants did not receive a nasal spray. They completed the same questionnaires and study visits as the spray group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthcare workers employed at the study hospital
- Age 18 years or older
- Able and willing to provide written informed consent
Key exclusion criteria (9 listed)
- Upper respiratory infection within 7 days before enrollment
- Diagnosis of COVID-19, RSV, or influenza within 7 days before enrollment
- History of nasal disorders, allergic rhinitis, asthma, chronic obstructive pulmonary disease (COPD), or other ear, nose, and throat disorders
- Daily use of other nasal sprays
- Nasal mucosal erosion, nasal ulceration, or nasal septal perforation
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 |
|---|---|---|
| Nasal SprayAlso: Profi Nasal Spray, PCANS (Pathogen Capture and Neutralizing Spray)Profi Nasal Spray (Akita Biosciences) is a drug-free nasal spray that forms a thin coating in the nose to help trap and clear airborne particles. It is made from ingredients already used in commercially available nasal and topical products. | Other | Nasal Spray Arm |
Primary outcome
Feasibility of using the nasal spray
Time frame: 8 weeks
Number of eligible healthcare workers who consented and enrolled in the study and continued to use the nasal spray.
Safety: Number of Participants With Adverse Events
Time frame: 12 weeks
Adverse events in the intervention and control groups, including new nasal discomfort or irritation, stinging or burning, changes in smell or taste, nosebleeds, and respiratory events, with duration and severity.
Acceptability: Adherence to Daily Use and Study Dropout
Time frame: Week 4 and Week 8
Adherence: proportion of intervention participants with less than 20% of the expected amount of spray remaining in the bottle (by weight), indicating use of more than 80% of expected doses. Dropout: proportion of participants in each group who withdrew or were lost to follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 39318086Joseph J, Baby HM, Quintero JR, Kenney D, Mebratu YA, Bhatia E, Shah P, Swain K, Lee D, Kaur S, Li XL, Mwangi J, Snapper O, Nair R, Agus E, Ranganathan S, Kage J, Gao J, Luo JN, Yu A, Park D, Douam F, Tesfaigzi Y, Karp JM, Joshi N. Toward a Radically Simple Multi-Modal Nasal Spray for Preventing Respiratory Infections. Adv Mater. 2024 Nov;36(46):e2406348. doi: 10.1002/adma.202406348. Epub 2024 Sep 24.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data publicly available. De-identified data may be shared by the study investigators upon reasonable request.
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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.
Vidya Menon, MD principal investigator
New York City Health and Hospitals Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Spray in people with Healthy Adults, run by Akita Biosciences, Inc. 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 22 Oct 2026. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of using the nasal spray (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07887958, which also lists 1 linked publication.
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 22 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.