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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02644135
Recruitment Status : Completed
First Posted : December 31, 2015
Results First Posted : November 1, 2022
Last Update Posted : November 1, 2022
Information provided by (Responsible Party):
University Hospitals Cleveland Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Halo Oral Spray Drug: Halo Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: A Pilot Study of the Safety, Tolerability, and Effectiveness of Halo to Prevent Acute Upper Respiratory Disease and Respiratory Virus Infections
Study Start Date : January 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Halo Oral Spray
Based upon the preliminary studies that assessed the duration of the antimicrobial effects of Halo as reported in the preliminary studies and feasibility, subjects assigned to both study arms will be asked to spray the product intra-orally 3 times daily (Three sprays per use, total = 9 sprays per day).
Drug: Halo Oral Spray
Three sprays per use, total = 9 sprays per day

Placebo Comparator: Halo Placebo
The placebo will consist of purified sterile water without CPC - the active antiseptic. Subjects assigned to both study arms will be asked to spray the product intra-orally 3 times daily (Three sprays per use, total = 9 sprays per day).
Drug: Halo Placebo
Three sprays per use, total = 9 sprays per day

Primary Outcome Measures :
  1. Number of Participants That Develop Acute Respiratory Illnesses When Using Halo vs Placebo [ Time Frame: Through study duration, an average of 3 months ]

Secondary Outcome Measures :
  1. Number of Acute Respiratory Illnesses [ Time Frame: Through study duration, an average of 3 months ]
    Measured by medical record review.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)
Mathers C, Fat DM, Boerma JT, World Health O. The global burden of disease : 2004 update. Geneva, Switzerland :: World Health Organization, 2008.
Merrill CT EA. Hospitalization in the United States, 2002. Rockville, MD: Agency for Healthcare Research and Quality. HCUP Fact Book No 6 2005; Publication number 05-0056.
Mukherjee PK, Chandra J, Jurevic RJ, Ghannoum A, Ghannoum MA. Activity of Oasis™ and Biotene™ mouthwashes against microbial biofilmsIADR/AADR/CADR 89th General Session. San Diego, CA: IADR/AADR, 2011.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02644135    
Other Study ID Numbers: 11-11-33
First Posted: December 31, 2015    Key Record Dates
Results First Posted: November 1, 2022
Last Update Posted: November 1, 2022
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospitals Cleveland Medical Center:
Healthy volunteer