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Trial registered on ANZCTR


Registration number
ACTRN12616001335482
Ethics application status
Approved
Date submitted
20/09/2016
Date registered
26/09/2016
Date last updated
26/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Co-Phenylcaine Spray: Can we improve the taste?
Scientific title
Comparing Co-Phenylcaine Forte Nasal Spray versus Co-Phenylcaine Forte Nasal Spray with Vanilla Liquid Flavour (L­132184) and Masking Liquid Flavour (50105AB) additives (CoPhenylcaine Zest): a phase III, randomised, double-­blind, crossover study.
Secondary ID [1] 290187 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nasendoscopy 300332 0
Condition category
Condition code
Anaesthesiology 300196 300196 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients received a one off dose of Lignocaine 5% + Phenylephidrine 0.5%, two actuations in each nostril (100 microlitres /spray), and within 6-36 hours two actuations of Lignocaine (4.8%) + Phenylephidrine (0.48%)+ vanilla concentrate additive (L-132184) and masking flavour (50105AB) titrated to a 4% concentration (2ml of additives added to make 50ml of solution) in each nostril (100 microlitres/spray) or vice versa.

The Investigator was responsible for administering all doses of medication.
Intervention code [1] 295943 0
Treatment: Drugs
Comparator / control treatment
Each participant received 2 actuations of Lignocaine 5% and Phenylephidrine spray (Co-Phenylcaine Forte) per nostril either before or after the modified spray.
Control group
Active

Outcomes
Primary outcome [1] 299681 0
Primary outcome 1: Overall spray preference A,B or no preference
Timepoint [1] 299681 0
This will be assessed after the participant has received both treatments.
Primary outcome [2] 299697 0
Primary outcome 2: Overall satisfaction rating scored on a 7 point scale
Timepoint [2] 299697 0
participants will assess each spray following administration
Secondary outcome [1] 327822 0
Secondary outcome: Aftertaste and strength of aftertaste - this will be assessed as a composite outcome on a 7 point scale
Timepoint [1] 327822 0
assessed following each treatment arm.
Secondary outcome [2] 327879 0
scent strength and pleasantness - composite outcome assessed on a 7 point scale.
Timepoint [2] 327879 0
assessed after each treatment arm
Secondary outcome [3] 327880 0
strength and pleasantness of initial taste - composite outcome assessed on a 7 point scale.
Timepoint [3] 327880 0
This will be assessed after each treatment arm
Secondary outcome [4] 327881 0
Level of irritation - assessed on a 7 point scale
Timepoint [4] 327881 0
This will be assessed after each treatment arm
Secondary outcome [5] 327882 0
Improvement in nasal patency - as assessed on a 7 point scale
Timepoint [5] 327882 0
after each treatment arm

Eligibility
Key inclusion criteria
1. Males or females aged between 18-60 years.
2. Employees of Metro South Hospital and Health Service at Princess Alexandra Hospital.
3. Available on two consecutive days from day of consent.
4. Currently healthy and well.
5. Able to read and complete Patient Information and Consent Form and questionnaire in English.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pregnant or possibility of being pregnant.
2. Previous hypersensitivity to local anaesthetics.
3. Recent nasal surgery.
4. Known nasal pathology, including sinusitis which affects daily living.
5. History of cardiac disease.

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
As per the Biostatistician. It is estimated that 37 subjects (74 samples) will be needed to test the hypothesis based on a similarly constructed study by Varshney et al. Although the methodology states that they used the Likert score to measure subject satisfaction no Likert results were provided by which to derive a sample size estimate. Results were provided for overall preference and these were used to estimate a sample size 12. This was felt to be underpowered as the null hypothesis: 100% no preference, was highly unrealistic and a test uninformative. In the absence of actionable information it was decided to replicate the original study sample size of 37 subjects (74 samples). A two tailed p-value <0.05 will be considered to be statistically significant.

Anticipating a maximum 15% loss to follow up due to people being unavailable on day 2, the sample size has been adjusted to 86.

To analyse the statistics SPSS statistics version 23 was used. The data was analysed using a one simple t-test, Fischer's Exact test and a Mann -Whitney U test.

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
Recruitment hospital [1] 6704 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 14341 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 294549 0
Hospital
Name [1] 294549 0
Princess Alexandra Hospital
Address [1] 294549 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
Queensland
4102
Country [1] 294549 0
Australia
Primary sponsor type
Individual
Name
Stuart Bailey
Address
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
Queensland
4102
Country
Australia
Secondary sponsor category [1] 293419 0
None
Name [1] 293419 0
Address [1] 293419 0
Country [1] 293419 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295987 0
Metro South Health Service District Human Research Ethics Committee (EC00167)
Ethics committee address [1] 295987 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
Queensland
4102
Ethics committee country [1] 295987 0
Australia
Date submitted for ethics approval [1] 295987 0
30/12/2015
Approval date [1] 295987 0
05/01/2016
Ethics approval number [1] 295987 0
HREC/15/QPAH/640

Summary
Brief summary
CoPhenylcaine Forte Nasal Spray is routinely used in the field of Otorhinolaryngology during ward rounds, clinics and theatre. The active ingredients, lignocaine and phenylephrine hydrochloride anaesthetise and cause vasoconstriction of the nasal passage to allow a clearer visual field for endoscopy with less discomfort for the patient. Multiple studies along with anecdotal evidence almost universally supports the notion that the spray has a distinctly unpleasant taste for patients. As is often done with medications that have an unpleasant taste, we are aiming to improve the overall taste profile and tolerability of CoPhenylcaine for patients, without affecting its efficacy, by adding a concentrated flavour and masking agent to the spray
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69154 0
A/Prof Ben Wallwork
Address 69154 0
C/Ward 1D Outpatients Department Level 1
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
Queensland
4102
Country 69154 0
Australia
Phone 69154 0
+6173176 5266
Fax 69154 0
Email 69154 0
ben@greenslopesent.com.au
Contact person for public queries
Name 69155 0
Dr Stuart Bailey
Address 69155 0
C/Ward 1D Outpatients Department Level 1
Princess Alexandra Hospital 199 Ipswich Road
Woolloongabba
Queensland
4102
Country 69155 0
Australia
Phone 69155 0
+61402658080
Fax 69155 0
Email 69155 0
stuart.bailey00@gmail.com
Contact person for scientific queries
Name 69156 0
Dr Stuart Bailey
Address 69156 0
C/Ward 1D Outpatients Department Level 1
Princess Alexandra Hospital 199 Ipswich Road
Woolloongabba
Queensland
4102
Country 69156 0
Australia
Phone 69156 0
+61402658080
Fax 69156 0
Email 69156 0
stuart.bailey00@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary