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

NCT02644135 | Completed Results

• 1 other identifier: 11-11-33
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Healthy volunteer

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Develop Acute Respiratory Illnesses When Using Halo vs Placebo

  Through study duration, an average of 3 months

Secondary Outcomes (1)

• Number of Acute Respiratory Illnesses

  Through study duration, an average of 3 months

Study Arms (2)

Halo Oral Spray

EXPERIMENTAL

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

Halo Placebo

PLACEBO COMPARATOR

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

Interventions

Halo Oral Spray DRUG

Three sprays per use, total = 9 sprays per day

Halo Oral Spray

Halo Placebo DRUG

Three sprays per use, total = 9 sprays per day

Halo Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent
• Ages between 18-45 years, inclusive
• Non-tobacco/nicotine use (at least 3 months)
• BMI of 17-35 kg/m2 inclusive
• Able to comply with all study procedures and follow-up
• Healthy on the basis of screening medical exam, blood chemistries, hematology, and serum pregnancy tests for females (at screening )
• Non-pregnant or breast-feeding

You may not qualify if:

• History of current use of narcotics, or recreational drug use.
• Use of \> 7 alcoholic beverages in 1 week
• Any acute illness such as asthma, cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal (including eating disorder), endocrine/metabolic, neurologic, dermatologic, or psychiatric disease.
• Treatment with another investigational product in the past 30 days
• Immunocompromised status including HIV by history
• Use of any other intra-oral product (especially antiseptic).
• Intended use of mouthwash during study duration
• Use of any systemic antibiotic or antifungal within 30 days of screening
• Prior or current history of seasonal allergies, chronic sinusitis or rhinitis
• Allergy to any component of Halo
• Oral lesions
• Dentures
• Dental Treatment currently in progress (implants, root canals, complex restorative procedures)

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Related Publications (38)

• Mathers C, Fat DM, Boerma JT, World Health O. The global burden of disease : 2004 update. Geneva, Switzerland :: World Health Organization, 2008.

  BACKGROUND

• Graham NM. The epidemiology of acute respiratory infections in children and adults: a global perspective. Epidemiol Rev. 1990;12:149-78. doi: 10.1093/oxfordjournals.epirev.a036050.

  PMID: 2286216 BACKGROUND

• 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.

  BACKGROUND

• van den Hoogen BG, de Jong JC, Groen J, Kuiken T, de Groot R, Fouchier RA, Osterhaus AD. A newly discovered human pneumovirus isolated from young children with respiratory tract disease. Nat Med. 2001 Jun;7(6):719-24. doi: 10.1038/89098.

  PMID: 11385510 BACKGROUND

• van der Hoek L, Pyrc K, Jebbink MF, Vermeulen-Oost W, Berkhout RJ, Wolthers KC, Wertheim-van Dillen PM, Kaandorp J, Spaargaren J, Berkhout B. Identification of a new human coronavirus. Nat Med. 2004 Apr;10(4):368-73. doi: 10.1038/nm1024. Epub 2004 Mar 21.

  PMID: 15034574 BACKGROUND

• Esper F, Weibel C, Ferguson D, Landry ML, Kahn JS. Evidence of a novel human coronavirus that is associated with respiratory tract disease in infants and young children. J Infect Dis. 2005 Feb 15;191(4):492-8. doi: 10.1086/428138. Epub 2005 Jan 14.

  PMID: 15655770 BACKGROUND

• Fouchier RA, Hartwig NG, Bestebroer TM, Niemeyer B, de Jong JC, Simon JH, Osterhaus AD. A previously undescribed coronavirus associated with respiratory disease in humans. Proc Natl Acad Sci U S A. 2004 Apr 20;101(16):6212-6. doi: 10.1073/pnas.0400762101. Epub 2004 Apr 8.

  PMID: 15073334 BACKGROUND

• Woo PC, Lau SK, Chu CM, Chan KH, Tsoi HW, Huang Y, Wong BH, Poon RW, Cai JJ, Luk WK, Poon LL, Wong SS, Guan Y, Peiris JS, Yuen KY. Characterization and complete genome sequence of a novel coronavirus, coronavirus HKU1, from patients with pneumonia. J Virol. 2005 Jan;79(2):884-95. doi: 10.1128/JVI.79.2.884-895.2005.

  PMID: 15613317 BACKGROUND

• Allander T, Tammi MT, Eriksson M, Bjerkner A, Tiveljung-Lindell A, Andersson B. Cloning of a human parvovirus by molecular screening of respiratory tract samples. Proc Natl Acad Sci U S A. 2005 Sep 6;102(36):12891-6. doi: 10.1073/pnas.0504666102. Epub 2005 Aug 23.

  PMID: 16118271 BACKGROUND

• Gaynor AM, Nissen MD, Whiley DM, Mackay IM, Lambert SB, Wu G, Brennan DC, Storch GA, Sloots TP, Wang D. Identification of a novel polyomavirus from patients with acute respiratory tract infections. PLoS Pathog. 2007 May 4;3(5):e64. doi: 10.1371/journal.ppat.0030064.

  PMID: 17480120 BACKGROUND

• Allander T, Andreasson K, Gupta S, Bjerkner A, Bogdanovic G, Persson MA, Dalianis T, Ramqvist T, Andersson B. Identification of a third human polyomavirus. J Virol. 2007 Apr;81(8):4130-6. doi: 10.1128/JVI.00028-07. Epub 2007 Feb 7.

  PMID: 17287263 BACKGROUND

• Chua KB, Crameri G, Hyatt A, Yu M, Tompang MR, Rosli J, McEachern J, Crameri S, Kumarasamy V, Eaton BT, Wang LF. A previously unknown reovirus of bat origin is associated with an acute respiratory disease in humans. Proc Natl Acad Sci U S A. 2007 Jul 3;104(27):11424-9. doi: 10.1073/pnas.0701372104. Epub 2007 Jun 25.

  PMID: 17592121 BACKGROUND

• Monto AS. Epidemiology of viral respiratory infections. Am J Med. 2002 Apr 22;112 Suppl 6A:4S-12S. doi: 10.1016/s0002-9343(01)01058-0.

  PMID: 11955454 BACKGROUND

• Rakes GP, Arruda E, Ingram JM, Hoover GE, Zambrano JC, Hayden FG, Platts-Mills TA, Heymann PW. Rhinovirus and respiratory syncytial virus in wheezing children requiring emergency care. IgE and eosinophil analyses. Am J Respir Crit Care Med. 1999 Mar;159(3):785-90. doi: 10.1164/ajrccm.159.3.9801052.

  PMID: 10051251 BACKGROUND

• Papadopoulos NG, Moustaki M, Tsolia M, Bossios A, Astra E, Prezerakou A, Gourgiotis D, Kafetzis D. Association of rhinovirus infection with increased disease severity in acute bronchiolitis. Am J Respir Crit Care Med. 2002 May 1;165(9):1285-9. doi: 10.1164/rccm.200112-118BC.

  PMID: 11991880 BACKGROUND

• Arden KE, Nissen MD, Sloots TP, Mackay IM. New human coronavirus, HCoV-NL63, associated with severe lower respiratory tract disease in Australia. J Med Virol. 2005 Mar;75(3):455-62. doi: 10.1002/jmv.20288.

  PMID: 15648064 BACKGROUND

• Esper F, Weibel C, Ferguson D, Landry ML, Kahn JS. Coronavirus HKU1 infection in the United States. Emerg Infect Dis. 2006 May;12(5):775-9. doi: 10.3201/eid1205.051316.

  PMID: 16704837 BACKGROUND

• Chidekel AS, Rosen CL, Bazzy AR. Rhinovirus infection associated with serious lower respiratory illness in patients with bronchopulmonary dysplasia. Pediatr Infect Dis J. 1997 Jan;16(1):43-7. doi: 10.1097/00006454-199701000-00010.

  PMID: 9002100 BACKGROUND

• Kim JO, Hodinka RL. Serious respiratory illness associated with rhinovirus infection in a pediatric population. Clin Diagn Virol. 1998 May 1;10(1):57-65. doi: 10.1016/s0928-0197(98)00004-x.

  PMID: 9646002 BACKGROUND

• Malcolm E, Arruda E, Hayden FG, Kaiser L. Clinical features of patients with acute respiratory illness and rhinovirus in their bronchoalveolar lavages. J Clin Virol. 2001 Apr;21(1):9-16. doi: 10.1016/s1386-6532(00)00180-3.

  PMID: 11255093 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Surveillance for pediatric deaths associated with 2009 pandemic influenza A (H1N1) virus infection - United States, April-August 2009. MMWR Morb Mortal Wkly Rep. 2009 Sep 4;58(34):941-7.

  PMID: 19730406 BACKGROUND

• Halasa NB. Update on the 2009 pandemic influenza A H1N1 in children. Curr Opin Pediatr. 2010 Feb;22(1):83-7. doi: 10.1097/MOP.0b013e3283350317.

  PMID: 20068413 BACKGROUND

• Thomas TL, Garland FC, Mole D, Cohen BA, Gudewicz TM, Spiro RT, Zahm SH. Health of U.S. Navy submarine crew during periods of isolation. Aviat Space Environ Med. 2003 Mar;74(3):260-5.

  PMID: 12650274 BACKGROUND

• Cross ER, Hermansen LA, Pugh WM, White MR, Hayes C, Hyams KC. Upper respiratory disease in deployed U.S. Navy shipboard personnel. Mil Med. 1992 Dec;157(12):649-51.

  PMID: 1470376 BACKGROUND

• White DW, Feigley CE, McKeown RE, Hout JJ, Hebert JR. Association between barracks type and acute respiratory infection in a gender integrated Army basic combat training population. Mil Med. 2011 Aug;176(8):909-14. doi: 10.7205/milmed-d-10-00418.

  PMID: 21882781 BACKGROUND

• Sanchez JL, Binn LN, Innis BL, Reynolds RD, Lee T, Mitchell-Raymundo F, Craig SC, Marquez JP, Shepherd GA, Polyak CS, Conolly J, Kohlhase KF. Epidemic of adenovirus-induced respiratory illness among US military recruits: epidemiologic and immunologic risk factors in healthy, young adults. J Med Virol. 2001 Dec;65(4):710-8. doi: 10.1002/jmv.2095.

  PMID: 11745936 BACKGROUND

• Zhanel GG, Kirkpatrick ID, Hoban DJ, Kabani AM, Karlowsky JA. Influence of human serum on pharmacodynamic properties of an investigational glycopeptide, LY333328, and comparator agents against Staphylococcus aureus. Antimicrob Agents Chemother. 1998 Sep;42(9):2427-30. doi: 10.1128/AAC.42.9.2427.

  PMID: 9736576 BACKGROUND

• Zhanel GG, Saunders DG, Hoban DJ, Karlowsky JA. Influence of human serum on antifungal pharmacodynamics with Candida albicans. Antimicrob Agents Chemother. 2001 Jul;45(7):2018-22. doi: 10.1128/AAC.45.7.2018-2022.2001.

  PMID: 11408217 BACKGROUND

• Manavathu EK, Ramesh MS, Baskaran I, Ganesan LT, Chandrasekar PH. A comparative study of the post-antifungal effect (PAFE) of amphotericin B, triazoles and echinocandins on Aspergillus fumigatus and Candida albicans. J Antimicrob Chemother. 2004 Feb;53(2):386-9. doi: 10.1093/jac/dkh066. Epub 2004 Jan 16.

  PMID: 14729762 BACKGROUND

• Clancy CJ, Huang H, Cheng S, Derendorf H, Nguyen MH. Characterizing the effects of caspofungin on Candida albicans, Candida parapsilosis, and Candida glabrata isolates by simultaneous time-kill and postantifungal-effect experiments. Antimicrob Agents Chemother. 2006 Jul;50(7):2569-72. doi: 10.1128/AAC.00291-06.

  PMID: 16801448 BACKGROUND

• Chandra J, Mukherjee PK, Ghannoum MA. In vitro growth and analysis of Candida biofilms. Nat Protoc. 2008;3(12):1909-24. doi: 10.1038/nprot.2008.192.

  PMID: 19180075 BACKGROUND

• 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.

  BACKGROUND

• Rouabhia M, Deslauriers N. Production and characterization of an in vitro engineered human oral mucosa. Biochem Cell Biol. 2002;80(2):189-95. doi: 10.1139/o01-237.

  PMID: 11989714 BACKGROUND

• Mukherjee PK, Mohamed S, Chandra J, Kuhn D, Liu S, Antar OS, Munyon R, Mitchell AP, Andes D, Chance MR, Rouabhia M, Ghannoum MA. Alcohol dehydrogenase restricts the ability of the pathogen Candida albicans to form a biofilm on catheter surfaces through an ethanol-based mechanism. Infect Immun. 2006 Jul;74(7):3804-16. doi: 10.1128/IAI.00161-06.

  PMID: 16790752 BACKGROUND

• Brittain-Long R, Nord S, Olofsson S, Westin J, Anderson LM, Lindh M. Multiplex real-time PCR for detection of respiratory tract infections. J Clin Virol. 2008 Jan;41(1):53-6. doi: 10.1016/j.jcv.2007.10.029.

  PMID: 18093871 BACKGROUND

• Mourez T, Bergeron A, Ribaud P, Scieux C, de Latour RP, Tazi A, Socie G, Simon F, LeGoff J. Polyomaviruses KI and WU in immunocompromised patients with respiratory disease. Emerg Infect Dis. 2009 Jan;15(1):107-9. doi: 10.3201/eid1501.080758.

  PMID: 19116066 BACKGROUND

• Chow BD, Esper FP. The human bocaviruses: a review and discussion of their role in infection. Clin Lab Med. 2009 Dec;29(4):695-713. doi: 10.1016/j.cll.2009.07.010.

  PMID: 19892229 BACKGROUND

• Mukherjee PK, Esper F, Buchheit K, Arters K, Adkins I, Ghannoum MA, Salata RA. Randomized, double-blind, placebo-controlled clinical trial to assess the safety and effectiveness of a novel dual-action oral topical formulation against upper respiratory infections. BMC Infect Dis. 2017 Jan 14;17(1):74. doi: 10.1186/s12879-016-2177-8.

  PMID: 28088167 DERIVED

Results Point of Contact

• Title: Dr. Robert Salata
• Organization: UHCMC

robert.salata@uhhospitals.org

2168443293

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 31, 2015
• Study Start: January 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 1, 2022
• Results First Posted: November 1, 2022

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share