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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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07887958). StuddyBuddy aggregates publicly available trial information.