ClinicalTrials.gg
CompletedNCT07887958Updated Oct 22, 2026

Feasibility, Acceptability, and Safety of a Drug-Free Nasal Spray in Frontline Healthcare Workers

An interventional study of Nasal Spray in Healthy Adults, sponsored by Akita Biosciences, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Akita Biosciences, Inc. · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Feb 2025, registered Oct 2026).
Updated Oct 22, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 133 studies in Patient Acceptance of Health Care with a site in United States — 23 open to participants now, 35 under way, 1 of them phase 3. Patient Acceptance of Health Care · United States.

Enrollment
65th of 108
127 · median 262
Started
2025
with 7 others
No phase
99 of 133
20 open now
Registered
133rd of 133
by date

Among the 133 studies in Patient Acceptance of Health Care with a site in United States, this one is the 65th largest by enrollment of the 108 interventional ones that give a count, is one of 8 that started in 2025, is one of 99 with no phase, and was the 133rd registered.

Patient Acceptance of Health Care

308 studies on the registry are indexed under Patient Acceptance of Health Care; 53 are open to participants now.

Browse Patient Acceptance of Health Care studies →

Open to participants now

23 of the 133 studies in Patient Acceptance of Health Care with a site in United States are open now. Recruiting first, the newest first:

18 more — sign in →

All 23 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 34 Patient Acceptance of Health Care studies recruiting now, 22 (65%) set no upper age limit and 9 (26%) stop at 75 or younger; 11 take children under 18; 16 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study 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 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.

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.

03

Conditions studied

  • Healthy Adults

Keywords

  • Nasal Spray
  • Healthcare Workers
  • Feasibility Studies
  • Safety
  • Acceptability
  • Patient Acceptance of Health Care
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthcare workers employed at the study hospital
  • Age 18 years or older
  • Able and willing to provide written

Exclusion criteria

Exclusion Criteria:

  • 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, (COPD), or other ear, nose, and throat disorders
  • Daily use of other nasal sprays
  • Nasal mucosal erosion, nasal ulceration, or nasal septal perforation
  • disorder
  • History of , 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 )
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
127 participants (actual)

Study arms

  • Experimental
    Nasal Spray Arm

    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.

    Other: Nasal Spray

  • No intervention
    No Spray (Control)

    Participants did not receive a nasal spray. They completed the same questionnaires and study visits as the spray group.

Interventions

  • OtherNasal 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.

    Also known as: Profi Nasal Spray, PCANS (Pathogen Capture and Neutralizing Spray)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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.

    Time frame: Week 4 and Week 8

07

Study locations

1 site
  • Lincoln Medical
    The Bronx, New York 10451, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2025 to primary completion in May 2025, 3 months.

Of 154 interventional studies with no phase under Patient Acceptance of Health Care, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2026
First posted
Oct 22, 2026
StartActual
Feb 26, 2025
Primary completionActual
May 30, 2025
CompletionActual
Jun 30, 2025
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07887958
Lead sponsor
Akita Biosciences, Inc.
Collaborators
New York City Health and Hospitals Corporation
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Feb 26, 2025
Primary completion
May 30, 2025
Completion
Jun 30, 2025
Last update
Oct 22, 2026

Study contacts

Vidya Menon, MD
principal investigator · New York City Health and Hospitals Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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