None listed
Conditions
Brief summary
This is a phase 3 randomised, double blind, placebo controlled efficacy study in 255 participants exhibiting the common cold. Subjects will dose 20 times over 5-6 days, max 4 doses a day. Subjects will also complete the WURSS 21 questionnaire from day 1 to Day 6, and complete item 1 from the questionnaire from day 7 to 14.
Interventions
Intervention is an aqueous buffered solution of 0.5% povidone-iodine (PVP-I) or matching placebo contained in a 30 mL bottle closed with a traditional nasal spray pump.
Subjects will receive a total of 20 doses, over 5-6 days. The maximum amount of doses a subject will take per day is 4. 1 dose consists of 6 x 140µL pump actuation's (3 into each nostril). Each dose will be administered in approximately 4 hour intervals.
The adherence of dosing will be monitored by the return of the bottle and
Intervention is an aqueous buffered solution of 0.5% povidone-iodine (PVP-I) or matching placebo contained in a 30 mL bottle closed with a traditional nasal spray pump. Subjects will receive a total of 20 doses, over 5-6 days. The maximum amount of doses a subject will take per day is 4. 1 dose consists of 6 x 140µL pump actuation's (3 into each nostril). Each dose will be administered in approximately 4 hour intervals. The adherence of dosing will be monitored by the return of the bottle and via diary entries via a webapp diary.
Sponsors
Firebrick Pharma Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Confirm age (18-65) and access to smartphone 2. Subject must report at least two of the following cold symptoms – sneezing, runny nose, nasal congestion, or sore throat – and have a total Jackson score of at least 3 points 3. Cold symptoms for less than 60 hours prior at enrolment; time and date of symptom onset will be noted 4. The PI or MO establishes a diagnosis of the common cold based on examination of presenting symptoms and medical history
Exclusion criteria
1. Fever greater than 38C or abnormal vital signs 2. Known iodine sensitivity 3. Known thyroid disease 4. Known immunodeficiency 5. Chronic respiratory diseases, including asthma, chronic cough, COPD, chronic allergic rhinitis or otherwise using chronic inhaled corticosteroids 6. Pregnant or nursing (lactating) or planning to become pregnant during the study 7. Visited a doctor in the previous 48 hours and had a diagnosis of allergic rhinitis, bacterial sinusitis or lower respiratory tract infection 8. Have any medical condition(s) deemed by the PI to interfere with assessments; this includes any nasal abnormalities as determined by nasal examination at enrolment. 9. Taking any prescription medication deemed by the MO to affect assessment of the investigational product 10. Intending to use during the study, OTC cold medications that could influence study results (antihistamines, decongestant nasal sprays, combination cough/cold medications); paracetamol will be available as a rescue medication for any disabling symptoms. 11. Intending to use a povidone-iodine gargle during the study 12. Unwilling to sign the informed consent form (PICF)
Outcome results
None listed