At a glance
ClinicalIndex Comparison Record- ✓Age 18-45 years inclusive
- ✓BMI 17-35 kg/m² inclusive
- ✓Non-tobacco/nicotine use for at least 3 months
- ✓Healthy on basis of screening medical exam, blood chemistries, hematology, and serum pregnancy tests
- ✕History of current use of narcotics or recreational drug use
- ✕More than 7 alcoholic beverages per week
- ✕Any acute illness including asthma, cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine/metabolic, neurologic, dermatologic, or psychiatric disease
- ✕Immunocompromised status including HIV
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of the Safety, Tolerability, and Effectiveness of Halo to Prevent Acute Upper Respiratory Disease and Respiratory Virus Infections
In Brief
A clinical study evaluating Halo Oral Spray and Halo Placebo for Healthy. Completed, enrolled 100 participants.
Detailed 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.
Study Details
Timeline
Interventions
Three sprays per use, total = 9 sprays per day
Three sprays per use, total = 9 sprays per day