None listed
Conditions
Brief summary
The aim of this study is to confirm earlier studies demonstrating safety and tolerability of inhaled aerosolised ethanol in adult volunteer participants. The ethanol will be administered to the upper and lower airways using a specifically-designed closed-circuit nebuliser system which improves delivery efficiency by minimising escape of volatile ethanol vapor during nebulisation and at the same time meets WHO requirements for safety and protection of nearby personnel from environmental aerosol exposure and exhaled virus particles. Confirmation of safety and tolerability will reassure physicians that inhaled ethanol can be used to treat COVID-19 and other viral and bacterial respiratory infections.
Interventions
Testing for safety and tolerability will be performed at one visit where participants will continuously inhale aerosolised ethanol delivered using a closed circuit nebuliser system specifically designed with an inflatable / deflatable reservoir, extension tubing, and a viral filter on the exhalation arm. This maximises delivery efficiency (particularly for volatile fluids) and minimises aerosol loss during nebulisation thus protecting nearby personnel from exposure to potentially toxic drug and
Testing for safety and tolerability will be performed at one visit where participants will continuously inhale aerosolised ethanol delivered using a closed circuit nebuliser system specifically designed with an inflatable / deflatable reservoir, extension tubing, and a viral filter on the exhalation arm. This maximises delivery efficiency (particularly for volatile fluids) and minimises aerosol loss during nebulisation thus protecting nearby personnel from exposure to potentially toxic drug and exhaled viral particles. The aerosol is delivered first to the upper airways via a nasal mask for 10 minutes followed by oral inhalation to the lower airway for 30 minutes with a 3-5 minute break in between for equipment changeover and testing. While previous studies support that adverse events and discomfort with oral inhalation to the lower airway are minimal and limited mainly to mild transient cough in a few patients, upper airway discomfort with exposure to high ethanol concentrations can be significant in some. This will therefore be alleviated by topical nasal mucosal analgesia using cophenylcaine 5% nasal spray (3 sprays each nostril - self-administered under guidance) together with cophenylcaine 3ml nebulised through a nasal mask by study staff to reach the posterior naso-pharyngeal area 30 minutes prior to ethanol nasal delivery. Upper and lower airway inhalation of aerosolised ethanol will be repeated 2 hours apart for a total of 3 doses with 3 different concentrations (40%, 60% and then 80% ethanol). All doses will be administered by a trained nurse under the supervision of a respiratory physician. Interruptions caused by the participant to upper or lower airway inhalation during dosing will be recorded together with the reasons for the interruption, the time period, and the subsequent action taken. Participants can choose to discontinue the study at any stage.
Sponsors
Telethon Kids Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Able to understand, give consent, and comply with all scheduled study visits, procedures and restrictions. 2. Group 1. Healthy adult volunteers (6 participants) as judged by the investigator based on medical history, physical examination, vital signs, laboratory tests and ECG; and is a non-smoker defined as not having smoked (inhalation of tobacco/nicotine or drugs of abuse) for four weeks prior to the study. 3. Group 2 participants with underlying lung disease as specified - smokers (4 participants see below), asthmatics (4 participants) and patients with cystic fibrosis (4 participants). These patients should have no other associated co-morbidities such as cardiovascular, renal or liver - either diagnosed or suspected through the tests listed to be performed at screening. Their underlying condition must be stable as defined by no exacerbations or significant changes in their underlying condition or treatment for the past four weeks. The participant will be advised to have the permission of their treating physician to participate in this study. 4. Group 2 participants in the smokers group must be regular smokers as defined by the minimum pack year history (1 pack/week for 6 months) and must be able to withhold smoking for the duration of the testing as they will be in a non-smoking environment and will not be able to leave the premises during testing. These patients should also have no other associated co-morbidities such as cardiovascular, renal or liver - either diagnosed or suspected through the tests performed at screening.
Exclusion criteria
1. Under the age of 18 years. No upper age limits. 2. The COVID-19 serology or swab test performed at screening is positive. 3. Participants with a known diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or who, at screening, have an FEV1/FVC reading on spirometry of less than 70% predicted which is indicative of COPD. 4. Participants in Group 2 who at screening have an FEV1 reading on spirometry of less than 40% predicted. 5. Positive hepatitis or HIV serology testing performed at screening. 6. Participant is pregnant or breast-feeding. 7. Participants known to be allergic or have reacted to alcohol in the past 8. Participants unable to be exposed to alcohol for any reason including religious or cultural reasons 9. In the opinion of the Investigator, the participant is unable to comply with the procedures required for the testing. 10. Previous history of alcohol dependence or abuse, defined as greater than 21 units per week for males and greater than 14 units per week for females. Where 1 unit equals 360 mL of beer, 150 mL wine or 45 mL of spirits. 11. No specific medications are to be avoided, although if in the opinion of the medical staff that a new medication reported prior to starting the study has the potential for an interaction with ethanol, the participant will be precluded from participating while on that medication.
Outcome results
None listed