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Trial registered on ANZCTR


Registration number
ACTRN12619000764134
Ethics application status
Approved
Date submitted
10/05/2019
Date registered
22/05/2019
Date last updated
13/12/2019
Date data sharing statement initially provided
22/05/2019
Date results information initially provided
13/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase III study of the safety and efficacy of povidone-iodine nasal spray (“Nasodine”) in the treatment of subjects with the common cold in the natural setting.
Scientific title
A phase III study of the safety and efficacy of povidone-iodine nasal spray (“Nasodine”) in the treatment of subjects with the common cold in the natural setting.
Secondary ID [1] 297913 0
Protocol Number: FBP-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Common Cold 312299 0
Condition category
Condition code
Infection 310858 310858 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314133 0
Treatment: Drugs
Comparator / control treatment
Matching placebo will consist of saline coloured with approved inert dye to match the Nasodine colour.
Control group
Placebo

Outcomes
Primary outcome [1] 319684 0
Nasal symptom score over days 1-5: Total score of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) questionnaire items: Runny nose, plugged nose, sneezing, and head congestion,
Timepoint [1] 319684 0
WURSS-21 completed once daily on Days 1-5.
Secondary outcome [1] 369186 0
Symptom Sub Score of WURSS-21: 5 day average of scores from 10 symptom related questions
Timepoint [1] 369186 0
WURSS-21 completed once daily on Days 1-5
Secondary outcome [2] 369187 0
Symptom severity on Day 3 versus baseline (Day 1) using WURSS-21.questionnaire.
Timepoint [2] 369187 0
WURSS-21 completed once on Day 1 and Day 3.
Secondary outcome [3] 369188 0
Change in cold severity over the 5 treatment days (Days 1-5) using the WURSS-21.questionnaire.
Timepoint [3] 369188 0
WURSS-21 completed daily on days 1-5
Secondary outcome [4] 369195 0
Duration of illness measured as the days (after Day 1) to reach a global illness score of zero (‘not sick’) and where the score remains zero for two consecutive days, using the WURSS-21.question 1.
Timepoint [4] 369195 0
WURSS-21 global illness score question 1 completed daily Day 1 to 14
Secondary outcome [5] 369196 0
Treatment Emergent Adverse Events and product tolerability
Timepoint [5] 369196 0
Adverse Event checks completed at all patient visits. Subjects are also asked about any changes in health after each dose on Days 1-6, and once daily for days 7-14. Special interest in AEs of nasal discomfort will be noted, as this is a known possible AE.
Vital sign assessment and Physical Examination are also performed on Day 1 and Day 6.
Secondary outcome [6] 369197 0
Time to cessation of viral shedding, assessed by nasal secretion swabs.
Timepoint [6] 369197 0
Performed in 48 subjects. Nasal secretion swabs to be completed on Days 1, 2, 3, 4, 6 and 14.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA

Funding & Sponsors
Funding source category [1] 302431 0
Commercial sector/Industry
Name [1] 302431 0
Firebrick Pharma Pty Ltd
Address [1] 302431 0
18 White Hills Rd, Creswick, Victoria, 3363
Country [1] 302431 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Firebrick Pharma Pty Ltd
Address
18 White Hills Rd, Creswick, Victoria, 3363
Country
Australia
Secondary sponsor category [1] 302332 0
Commercial sector/Industry
Name [1] 302332 0
Avance Clinical Pty Ltd
Address [1] 302332 0
Level 1, 2 Ann Nelson Drive, Thebarton South Australia 5031
Country [1] 302332 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303100 0
Bellberry Human Research Ethics Committee E (TGA HREC Code: EC00450)
Ethics committee address [1] 303100 0
123 Glen Osmond Rd, Eastwood SA 5063
Ethics committee country [1] 303100 0
Australia
Date submitted for ethics approval [1] 303100 0
17/04/2019
Approval date [1] 303100 0
15/05/2019
Ethics approval number [1] 303100 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92470 0
Dr Thomas Polasek
Address 92470 0
CMAX Clinical Research Pty Ltd Level 5, 18a North Terrace, Adelaide, South Australia, 5000
Country 92470 0
Australia
Phone 92470 0
+61 458 162 715
Fax 92470 0
Email 92470 0
Tom.Polasek@certara.com
Contact person for public queries
Name 92471 0
Dr Thomas Polasek
Address 92471 0
CMAX Clinical Research Pty Ltd Level 5, 18a North Terrace, Adelaide, South Australia, 5000
Country 92471 0
Australia
Phone 92471 0
+61 458 162 715
Fax 92471 0
Email 92471 0
Tom.Polasek@certara.com
Contact person for scientific queries
Name 92472 0
Dr Thomas Polasek
Address 92472 0
CMAX Clinical Research Pty Ltd Level 5, 18a North Terrace, Adelaide, South Australia, 5000
Country 92472 0
Australia
Phone 92472 0
+61 458 162 715
Fax 92472 0
Email 92472 0
Tom.Polasek@certara.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No Plan to share data
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary