Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001244291
Ethics application status
Approved
Date submitted
9/07/2018
Date registered
23/07/2018
Date last updated
26/06/2019
Date data sharing statement initially provided
26/06/2019
Date results information initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase I/II study of povidone-iodine nasal spray (“Nasodine”) to investigate safety and tolerability in healthy volunteers (Stage 1), and to investigate safety and efficacy in patients with the common cold (Stage 2).
Scientific title
A phase I/II study of povidone-iodine nasal spray (“Nasodine”) to investigate safety and tolerability in healthy volunteers (Stage 1), and to investigate safety and efficacy in patients with the common cold (Stage 2).
Secondary ID [1] 295443 0
Protocol Number: FBP-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Common Cold 308700 0
Condition category
Condition code
Infection 307638 307638 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is an aqueous buffered solution of povidone-iodine (PVP-I) or matching placebo contained in a 30 mL bottle closed with a traditional nasal spray pump.
This 2 stage study consists of:
Stage 1: An open-label Phase 1 study in ten (10) healthy volunteers at a single site to investigate safety and iodine adsorption. Participants will receive a total of 21 doses, over 6 days; 4 times on Days 1,2,3,4,5 and 1 time on the morning of Day 6. 1 dose consists of 8 x 140µL pump actuation's (4 into each nostril). Each dose will be administered in approximately 4 hour intervals.
Stage 2: a two site, randomised, double-blind, placebo-controlled safety and efficacy study in 258 participants exhibiting the common cold. Participants will receive a total of 21 doses, over 5-6 days; the time that a participant is dosed on Day 1 will determine how many doses per day will be required. 1 dose consists of 8 x 140µL pump actuation's (4 into each nostril). Each dose will be administered in approximately 4 hour intervals.
The adherence of dosing in both stages will be monitored by the return of the used product and via diary entries in a dosing diary in Stage 1, and via a webapp diary in Stage 2.
Intervention code [1] 301753 0
Treatment: Drugs
Comparator / control treatment
The placebo is a solution without povidone-iodine, containing BP and USP approved inactive excipient's, coloured with a TGA approved dye to mimic the colour of the active product, closed in a 30 mL bottle with a traditional nasal spray pump.
Control group
Placebo

Outcomes
Primary outcome [1] 306622 0
Stage 1 Outcome.
Measurement of systemic iodine exposure after Nasodine treatment and again after a 5 day course of treatment.
Timepoint [1] 306622 0
Blood samples taken before and after the first and last dose administration are to be analysed for serum iodine. Urine collected before and after the first and last dose administration are to be analysed for urine iodine. T3, T4 and TSH will be measured before treatment and after 35 days to determine any significant change in thyroid function.
Primary outcome [2] 306656 0
Stage 2:
Measurement of cold symptom severity over a 5-day treatment period calculated from the daily WURSS-21 scores for each subject.
Timepoint [2] 306656 0
Partiicpants will record cold symptoms, using daily WURSS-21 questionnaires, in an electronic diary from which the difference between Nasodine and placebo participant responses can be assessed. This will be assessed at enrollment on Day 1 and daily up to and including Day 14.
Secondary outcome [1] 349042 0
Assessment of the safety and tolerability of multiple doses of Nasodine over 5 days using the proposed treatment regimen.
Examples of known/possible adverse events include; shortness of breath, itching, red skin rash, lip swelling, throat swelling, possible thyroid dysfunction, changes in voice, and local nasal discomfort and irritation.
Timepoint [1] 349042 0
Adverse events, vital signs and blood test results will be assessed for determination of general tolerability. Vital signs, nasal examinations and adverse events will be collated for determination of safety.
Adverse events will be assessed from dosing (Day 1) until the end of study visit (EOS) on Day 35 for both stages. AE probes will be performed while participants are in house on Day-1, Day 1, Day 6 and Day 35 for Stage 1.
AE probes will be performed while participants are in house on Day-1, Day 1, Day 6, Day 14 and Day 35 for Stage 2. Subjects will also be probed for AEs daily on the webapp application from Day 1 through to Day 14.
Vital signs will be assessed at screening, Day -1, Day 1, Day 6 and at the EOS visit on Day 35 in Stage 1.
Vital Signs will be assessed on Visit 1 (screening/Day 1), Day 6, Day 14 and the EOS visit on Day 35 for Stage 2.
Blood tests (Haematology and Serum Chemistry) will be performed at screening, Day 1, Day 6 and at the EOS on day 35 for Stage 1.
Blood tests (Haematology and Serum Chemistry) will be performed at Visit 1, Day 6 and at the EOS on Day 35 for Stage 2.
Nasal examinations will be performed at Screening, Day -1, Day 1, Day 6 and at the EOS on Day 35 for Stage 1.
Nasal examinations will be performed at Screening, Visit 1, Day 6, Day 14 and at the EOS on Day 35 for Stage 2.

Eligibility
Key inclusion criteria
Stage 1:
1. A healthy adult (18-55 years old)
2. Exhibit as no clinically relevant abnormalities as determined by past medical history, physical examination, vital signs, and laboratory tests at Screening.
3. Female subjects of childbearing potential must have a confirmed negative pregnancy test at the start of the study (Screening and Day -1) and also agree to abstain from sexual intercourse or use a highly effective method of birth control for the duration of the study and for 90 days after last dose of study drug, as determined by the investigator. Female participants of non-childbearing potential, defined as surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or clinically documented to be postmenopausal.
4. Male subjects must agree to abstain from sexual intercourse or use a highly effective method of birth control with partners of childbearing potential for the duration of the study and for 90 days after last dose of study drug.

Stage 2:
1. Adult (18-65) participants who have a cold or are coming down with a cold
2. 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 6 points. Jackson scores are simple sums of severity ratings (0 = absent, 1 = mild, 2 = moderate, 3 = severe).
3. Have had cold symptoms for at least 24 hours at the time they commence treatment.
4. Access to a smartphone or tablet.
5. Female subjects of childbearing potential must have a confirmed negative pregnancy test at the start of the study (Screening and Day -1) and also agree to abstain from sexual intercourse or use a highly effective method of birth control for the duration of the study and for 90 days after last dose of study drug, as determined by the investigator. Female participants of nonchildbearing potential, defined as surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or clinically documented to be postmenopausal.
6. Male subjects must agree to abstain from sexual intercourse or use a highly effective method of birth control with partners of childbearing potential for the duration of the study and for 90 days after last dose of study drug.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Stage 1:
1. Upper respiratory tract infection in the 4 weeks prior to the first dose of investigational product
2. Visited a doctor in the previous 48 hours and had a diagnosis of allergic rhinitis, bacterial sinusitis or LRTI
3. Fever (>38 degrees Celsius), tachycardia greater than or equal to 100 bpm, bradycardia less than or equal to 50 bpm, BP greater than or equal to 160 systolic or greater than or equal to 110 diastolic or BP less than or equal to 100 systolic or less than or equal to 50 diastolic, respiratory rate greater than or equal to 20 breaths per minute
4. Using or intending to use a povidone-iodine gargle during the study
5. Previous diagnoses of nasal polyps or any ear, nose and throat pathology deemed by the Principal Investigator or delegate to affect assessment of the investigational product
6. Known iodine sensitivity
7. Previous diagnosis of thyroid disease/dysfunction
8. Pregnant or nursing (lactating) or planning to become pregnant
9. Detected illicit drug use or under the influence of alcohol
10. Use of systemic decongestants, decongestant nasal sprays or any other intranasal drugs or medications in the 4 weeks prior to the first dose of investigational product
11. Subject with presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment

Stage 2:
1. Visited a doctor in the previous 48 hours and had a diagnosis of allergic rhinitis, bacterial sinusitis or LRTI
2. Fever (>38 degrees Celsius ), tachycardia greater than or equal to 100 bpm, bradycardia less than or equal to 50 bpm, BP greater than or equal to 160 systolic or greater than or equal to 110 diastolic or BP less than or equal to 100 systolic or less than or equal to 50 diastolic, respiratory rate greater than or equal to 20 breaths per minute
3. Lower respiratory tract infection signs or symptoms
4. Is considered too unwell based on global medical assessment
5. Self-reporting of normally very mild cold symptoms with a common cold, including duration of illness of < 48 hours
6. Previous diagnoses of nasal polyps or any ear, nose and throat pathology deemed by the Principal Investigator or delegate to affect assessment of the investigational product
7. Previous diagnoses of any chronic respiratory diseases, including asthma, chronic cough, COPD etc.
8. Known immunodeficiency
9. Known iodine sensitivity
10. Previous diagnosis of thyroid disease/ dysfunction
11. Pregnant or nursing (lactating) or planning to become pregnant
12. Any medical condition deemed by the Principal Investigator or delegate to affect assessment of the investigational product
14. Participated in another clinical trial within the past 30 days
15. Using or intending to use a povidone-iodine gargle during the study
16. Taking any OTC cold medications/complementary or herbal products or intending to do so (paracetamol will be available as rescue medication for disabling symptoms)
17. Detected illicit drug use or under the influence of alcohol as determined by routine diagnostic assays

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 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
End of seasonal disease cycle that resulted in the cessation of the presentation of eligible subjects for the study
Date of first participant enrolment
Anticipated
30/07/2018
Actual
30/07/2018
Date of last participant enrolment
Anticipated
Actual
9/11/2018
Date of last data collection
Anticipated
Actual
15/03/2019
Sample size
Target
268
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 11325 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment hospital [2] 11328 0
Health Hub Morayfield - Morayfield
Recruitment postcode(s) [1] 23225 0
4506 - Morayfield
Recruitment postcode(s) [2] 23222 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 300033 0
Commercial sector/Industry
Name [1] 300033 0
Firebrick Pharma Pty Ltd
Country [1] 300033 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] 299425 0
Commercial sector/Industry
Name [1] 299425 0
CPR Pharma Services Pty. Ltd.
Address [1] 299425 0
28 Dalgleish Street,
Thebarton, Adelaide,
South Australia 5031
Country [1] 299425 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300882 0
Bellberry Human Research Ethics Committee E [EC00450]
Ethics committee address [1] 300882 0
129 Glen Osmond Road
Eastwood, Adelaide,
South Australia 5063
Ethics committee country [1] 300882 0
Australia
Date submitted for ethics approval [1] 300882 0
31/05/2018
Approval date [1] 300882 0
19/07/2018
Ethics approval number [1] 300882 0
2018-05-407

Summary
Brief summary
This is a 2 stage study consisting of an initial open label study in ten (10) healthy volunteers to assess safety and iodine adsorption followed by a randomised, double blind, placebo controlled efficacy study in 258 participants exhibiting the common cold.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85146 0
Dr Thomas Polasek
Address 85146 0
CMAX Clinical Research Pty Ltd
Level 5, 18a North Terrace,
Adelaide, South Australia, 5000,
Country 85146 0
Australia
Phone 85146 0
+61 458 162 715
Fax 85146 0
Email 85146 0
Tom.Polasek@certara.com
Contact person for public queries
Name 85147 0
Dr Thomas Polasek
Address 85147 0
CMAX Clinical Research Pty Ltd
Level 5, 18a North Terrace,
Adelaide, South Australia, 5000,
Country 85147 0
Australia
Phone 85147 0
+61 458 162 715
Fax 85147 0
Email 85147 0
Tom.Polasek@certara.com
Contact person for scientific queries
Name 85148 0
Dr Thomas Polasek
Address 85148 0
CMAX Clinical Research Pty Ltd
Level 5, 18a North Terrace,
Adelaide, South Australia, 5000,
Country 85148 0
Australia
Phone 85148 0
+61 458 162 715
Fax 85148 0
Email 85148 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 Data Sharing Plan in place at the time of the study


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
No additional documents have been identified.