URI: Safety and Effectiveness of an Oral CPC Spray

Pranab K. Mukherjee, Ph.D. Assistant Professor Center for Medical Mycology Department of Dermatology University Hospitals Case Medical Center Case Western Reserve University Cleveland, OH 44106-5028MedicalResearch.com Interview with:
Pranab K. Mukherjee, Ph.D.
Assistant Professor
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.

Citation:

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.

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