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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.
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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.
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Secondary ID [1]
297913
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Protocol Number: FBP-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Common Cold
312299
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Condition category
Condition code
Infection
310858
310858
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
314133
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Treatment: Drugs
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Comparator / control treatment
Matching placebo will consist of saline coloured with approved inert dye to match the Nasodine colour.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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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,
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Assessment method [1]
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Timepoint [1]
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WURSS-21 completed once daily on Days 1-5.
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Secondary outcome [1]
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Symptom Sub Score of WURSS-21: 5 day average of scores from 10 symptom related questions
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Assessment method [1]
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Timepoint [1]
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WURSS-21 completed once daily on Days 1-5
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Secondary outcome [2]
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Symptom severity on Day 3 versus baseline (Day 1) using WURSS-21.questionnaire.
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Assessment method [2]
369187
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Timepoint [2]
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WURSS-21 completed once on Day 1 and Day 3.
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Secondary outcome [3]
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Change in cold severity over the 5 treatment days (Days 1-5) using the WURSS-21.questionnaire.
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Assessment method [3]
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Timepoint [3]
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WURSS-21 completed daily on days 1-5
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Secondary outcome [4]
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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.
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Assessment method [4]
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Timepoint [4]
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WURSS-21 global illness score question 1 completed daily Day 1 to 14
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Secondary outcome [5]
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Treatment Emergent Adverse Events and product tolerability
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Assessment method [5]
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Timepoint [5]
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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.
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Secondary outcome [6]
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Time to cessation of viral shedding, assessed by nasal secretion swabs.
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Assessment method [6]
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Timepoint [6]
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Performed in 48 subjects. Nasal secretion swabs to be completed on Days 1, 2, 3, 4, 6 and 14.
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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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
23/05/2019
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Actual
6/06/2019
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Date of last participant enrolment
Anticipated
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Actual
16/10/2019
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Date of last data collection
Anticipated
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Actual
27/11/2019
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Sample size
Target
255
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Accrual to date
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Final
256
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Recruitment in Australia
Recruitment state(s)
QLD,SA
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Firebrick Pharma Pty Ltd
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Address [1]
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18 White Hills Rd, Creswick, Victoria, 3363
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Country [1]
302431
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Firebrick Pharma Pty Ltd
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Address
18 White Hills Rd, Creswick, Victoria, 3363
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Country
Australia
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Avance Clinical Pty Ltd
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Address [1]
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Level 1, 2 Ann Nelson Drive, Thebarton South Australia 5031
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Country [1]
302332
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry Human Research Ethics Committee E (TGA HREC Code: EC00450)
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Ethics committee address [1]
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123 Glen Osmond Rd, Eastwood SA 5063
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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17/04/2019
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Approval date [1]
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15/05/2019
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Ethics approval number [1]
303100
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Thomas Polasek
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Address
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CMAX Clinical Research Pty Ltd Level 5, 18a North Terrace, Adelaide, South Australia, 5000
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Country
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Australia
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Phone
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+61 458 162 715
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Thomas Polasek
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Address
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CMAX Clinical Research Pty Ltd Level 5, 18a North Terrace, Adelaide, South Australia, 5000
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Country
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Australia
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Phone
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+61 458 162 715
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Thomas Polasek
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Address
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CMAX Clinical Research Pty Ltd Level 5, 18a North Terrace, Adelaide, South Australia, 5000
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Country
92472
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Australia
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Phone
92472
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+61 458 162 715
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Fax
92472
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Email
92472
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No Plan to share data
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
In vitro Nasodine Can be an Effective Antibiofilm Agent for Biofilms that May Cause CRS
2023
https://doi.org/10.1002/lary.30558
Dimensions AI
In vivo (human) and in vitro inactivation of SARS-CoV-2 with 0.5% povidone-iodine nasal spray
2022
https://doi.org/10.21037/ajo-21-40
N.B. These documents automatically identified may not have been verified by the study sponsor.
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