A Pilot Study of the Safety, Tolerability, and Effectiveness of Halo

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center

Criteria

Inclusion Criteria:

1. Signed informed consent

2. Ages between 18-45 years, inclusive

3. Non-tobacco/nicotine use (at least 3 months)

4. BMI of 17-35 kg/m2 inclusive

5. Able to comply with all study procedures and follow-up

6. Healthy on the basis of screening medical exam, blood chemistries, hematology, and serum pregnancy tests for females (at screening )

7. Non-pregnant or breast-feeding

Exclusion Criteria:

1. History of current use of narcotics, or recreational drug use.

2. Use of > 7 alcoholic beverages in 1 week

3. Any acute illness such as asthma, cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal (including eating disorder), endocrine/metabolic, neurologic, dermatologic, or psychiatric disease.

4. Treatment with another investigational product in the past 30 days

5. Immunocompromised status including HIV by history

6. Use of any other intra-oral product (especially antiseptic).

7. Intended use of mouthwash during study duration

8. Laboratory (screening) of creatinine > 1.5 X ULN, hemoglobin < 10.5 g/dL, platelet count ≤ 99,000/mm3, absolute neutrophil count ≤1200/ mm3, serum glucose ≥ 150 mg/dl (Subject can enroll prior to receiving lab results. Subject will be contacted if lab results are an exclusion and discontinue from study)

9. Use of any systemic antibiotic or antifungal within 30 days of screening

10. Prior or current history of seasonal allergies, chronic sinusitis or rhinitis

11. Allergy to any component of Halo

12. Oral lesions

13. Dentures

14. Dental Treatment currently in progress (implants, root canals, complex restorative procedures)