← Back to all trials
Completed
NCT07887958
Feasibility, Acceptability, and Safety of a Drug-Free Nasal Spray in Frontline Healthcare Workers
Conditions: Healthy Adults
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 127
Sponsor: Akita Biosciences, Inc.
Location: Lincoln Medical The Bronx New York
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.
Eligibility Criteria
Inclusion Criteria:
* Healthcare workers employed at the study hospital
* Age 18 years or older
* Able and willing to provide written informed consent
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, 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)
Source: ClinicalTrials.gov (NCT07887958). StuddyBuddy aggregates publicly available trial information.