A Pilot Study of the Safety, Tolerability, and Effectiveness of Halo
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
This is a pilot study of the safety, tolerability, and effectiveness of Halo to prevent acute
upper respiratory illness and respiratory virus infections. This study will be conducted at
one site (University Hospitals Case Medical Center) in healthy adults during the upcoming
respiratory virus season (12/15/11 to 3/14/12). The intervention will be with Halo, a
commercial product which is FDA-approved for the treatment of xerostomia. The placebo will
consist of the phosphate buffered saline plus the preservatives in the Halo formulation and
without CPC - the active antiseptic. This placebo was chosen as the Halo formulation without
CPC serves to act as a barrier to attachment of oral pathogens, and as such is an important
contributing factor to its antimicrobial activity (see above). Also, the formulation without
CPC with preservatives exhibits some antibacterial and antiviral activity. Moreover, the
formulation without CPC and no preservatives is easily contaminated and not practical to
utilize as the placebo in these studies.
Male and female participants 18-45 years of age will be recruited and monitored for the
development of, duration, and severity of clinical symptoms and signs consistent with acute
respiratory disease (defined below) captured daily through diaries, and PCR confirmation of
important respiratory viruses including influenza, rhinoviruses, adenoviruses, and
respiratory syncytial virus during episodes of acute respiratory disease during the length of
the study will be undertaken. Secondary objectives will assess the tolerance, acceptability
and adherence to Halo as well as the change in the bacterial (oral streptococci and Group A
streptococcus) and fungal microflora in the oropharynx. School or work absenteeism, visits to
physicians' offices, emergency departments and urgent care centers will also be captured.
Conventional cultures for these bacterial and fungal organisms will be pursued (see below).
Throughout the study period, the safety, tolerability, acceptability and adherence to study
products will be assessed.