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

NCT07887958 | Completed

• 2 other identifiers: AKITA-NYCHH-2025-0123-02-231-134(HHC)
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adults

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Week 4 and Week 8

Study Arms (2)

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.

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.

Interventions

Nasal Spray OTHER

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)

Nasal Spray Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Akita Biosciences, Inc.: lead
• New York City Health and Hospitals Corporation: collaborator

Study Sites (1)

Lincoln Medical

The Bronx, New York, 10451, United States

Location

Related Publications (1)

• 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.

  PMID: 39318086 BACKGROUND

MeSH Terms

Conditions

Patient Acceptance of Health Care

Interventions

Nasal Sprays

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Vidya Menon, MD

  New York City Health and Hospitals Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants were randomized 1:1 to use the nasal spray twice daily for 8 weeks or to receive no spray (untreated control).

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 22, 2026
• Study Start: February 26, 2025
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 22, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)