13 Sep URI: Safety and Effectiveness of an Oral CPC Spray
MedicalResearch.com Interview with:
Pranab K. Mukherjee, Ph.D.
Center for Medical Mycology
Department of Dermatology
University Hospitals Case Medical Center
Case Western Reserve University
Cleveland, OH 44106-5028
MedicalResearch.com: What are the main findings of the study?
Answer: We performed a randomized double-blinded placebo-controlled pilot clinical trial to assess the safety, tolerability and effectiveness of a cetylpyridinium chloride (CPC)-based oral spray in the prevention of acute upper respiratory tract infections (URIs).
- The tested CPC spray (ARMS-I, developed by Arms Pharmaceutical LLC, Cleveland, OH) was safe and exhibited high tolerability and acceptability among study participants
- The product exhibited a trend to protect against URIs (55% relative reduction compared to the placebo), based on confirmed URIs, post-medication exit interviews, and daily electronic diaries completed by study participants
- There was statistically significant reduction in frequency of cough and sore throat in the active group
- The number of days (duration) of cough was significantly reduced in the active group compared to placebo arm
- URI-associated viruses (influenza, rhinovirus and coronavirus) were detected in three individuals, all in the placebo arm. No virus was detected in the active arm/
- No drug-related adverse events or oral lesions were observed
- Previous vaccination status of the study participants did not affect the study outcome.
MedicalResearch.com: Were any of the findings unexpected?
Answer: Use of ARMS-I showed increasing protection against URIs with continued use of the product (did not reach statistical significance), suggesting a potential “residual effect”.
MedicalResearch.com: What should clinicians and patients take away from your report?
Answer: ARMS-I spray may have utility in the prevention of URIs and associated symptoms.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Answer: Perform a Phase-III randomized double-blinded placebo-controlled clinical trial to confirm the efficacy of ARMS-I in reducing the frequency, severity and duration of URIs.
Interscience Conference on Anti-Microbial Agents and Chemotherapy
Source reference: Ghannoum M, et al “A barrier-forming oral formulation exhibits sustained post-antimicrobial effect” ICAAC 2013; Abstract B-031.