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Trial registered on ANZCTR


Registration number
ACTRN12618000417280
Ethics application status
Approved
Date submitted
8/03/2018
Date registered
22/03/2018
Date last updated
24/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An open label assessment of the safety of increased concentrations and doses of Citramel inhalation in healthy volunteers
Scientific title
An open label assessment of the safety of increased concentrations and doses of Citramel inhalation in healthy volunteers
Secondary ID [1] 294239 0
BE10-1003
Universal Trial Number (UTN)
U1111-1204-6403
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 306915 0
Condition category
Condition code
Human Genetics and Inherited Disorders 306008 306008 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cohort 1: Citramel Low Dose - an aqueous solution of sodium citrate (16.18 mg/mL), citric
acid (0.046 mg/mL) and ammonium chloride (4.12 mg/mL).
Cohort 2: Citramel Medium Dose - an aqueous solution of sodium citrate (48.54 mg/mL), citric acid (0.138 mg/mL) and ammonium chloride (12.36 mg/mL).
Cohort 3: Citramel High Dose (if administered) - an aqueous solution of sodium citrate (64.72 mg/mL), citric acid (0.184 mg/mL) and ammonium chloride (16.48 mg/mL).
Administered by aerosol twice daily (morning and night) for 28 days. Compliance will
be assessed by checking the vials returned by study participants.
Intervention code [1] 300533 0
Treatment: Drugs
Comparator / control treatment
Reference Cohort 1 (Low dose Citramel); Comparator cohorts 2 and 3 (Medium and High Dose Citramel)
Control group
Dose comparison

Outcomes
Primary outcome [1] 305085 0
Safety as assessed by Adverse events, Vital signs, spirometry and Laboratory Tests
Adverse events that may be expected include throat irritation, cough, wheeze, runny nose, sore throat, chest tightness, worsening lung function tiredness, dry mouth and nausea.
Timepoint [1] 305085 0
Screening and/or Baseline, then weekly to Day 28. Adverse events checked by phone call approx 2 weeks after Day 28
Primary outcome [2] 305086 0
Participant self-assessment of tolerability of Citramel using a 5 point Likert scale questionnaire. Options range from 'Very poor' to 'very good'
Timepoint [2] 305086 0
At weeks 1, 2, 3 and 4
Secondary outcome [1] 344117 0
No secondary outcomes
Timepoint [1] 344117 0
N/A

Eligibility
Key inclusion criteria
Healthy volunteers aged 18-60 years who provide written informed consent; BMI 18-32 kg/m2; FEV1 between 80-120% of normal range; sexually active females must use effective contraception.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinically significant co-existing disease; smoker; any medications (except oral contraceptives); ECG or blood pressure abnormalities; positive results on drugs of abuse or alcohol screen; greater than 15% improvement in FEV1 15 minutes post dose of bronchodilator at screening; known exposure to ammonium chloride in the workplace; hospital admission in previous 30 days;

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis
This is a Phase 1 safety assessment of Citramel in three cohorts each of five healthy volunteers and is not based on a formal sample size calculation. There are no formal statistical hypotheses associated with this open label assessment and only descriptive statistics will be undertaken.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The company has decided to cease further development of Citramel as Breathe Easy has been unable to identify a commercially viable path to market for Citramel.
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 outside Australia
Country [1] 9661 0
New Zealand
State/province [1] 9661 0
Auckland

Funding & Sponsors
Funding source category [1] 298878 0
Commercial sector/Industry
Name [1] 298878 0
Breathe Easy Limited
Address [1] 298878 0
Whitecliff College of Arts and Design Building, 24 Balfour Road, Parnell, Auckland 1052, New Zealand
Country [1] 298878 0
New Zealand
Funding source category [2] 298914 0
Government body
Name [2] 298914 0
Ministry of Business Innovation and Employment
Address [2] 298914 0
Callaghan Grant, MBIE
15 Stout Street, Wellington 6011, New Zealand
Country [2] 298914 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Breathe Easy Limited
Address
Whitecliff College of Arts and Design Building, 24 Balfour Road, Parnell, Auckland 1052, New Zealand
Country
New Zealand
Secondary sponsor category [1] 298090 0
None
Name [1] 298090 0
N/A
Address [1] 298090 0
N/A
Country [1] 298090 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299820 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 299820 0
1 The Terrace
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 299820 0
New Zealand
Date submitted for ethics approval [1] 299820 0
29/11/2017
Approval date [1] 299820 0
14/02/2018
Ethics approval number [1] 299820 0
17/NTB/235

Summary
Brief summary
This is a research study to evaluate ascending doses and concentrations of Citramel inhalation. It is open label administration of Citramel to three cohorts, each of 5 healthy volunteers, to evaluate safety and tolerability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81666 0
Dr Bridget Maher
Address 81666 0
Auckland Clinical Studies (ACS), 3 Ferncroft Street, Grafton, Auckland 1010, New Zealand
Country 81666 0
New Zealand
Phone 81666 0
+64 9 373 4383
Fax 81666 0
Email 81666 0
bridget@clinicalstudies.co.nz
Contact person for public queries
Name 81667 0
Mr Jon Broadley
Address 81667 0
Breathe Easy Ltd, Whitecliff College of Arts and Design Building, 24 Balfour Road, Parnell, Auckland 1052
Country 81667 0
New Zealand
Phone 81667 0
+64 272 333 111
Fax 81667 0
Email 81667 0
jon@strategyplus.nz
Contact person for scientific queries
Name 81668 0
Mr Kieran Jina
Address 81668 0
Breathe Easy Ltd, Whitecliff College of Arts and Design Building, 24 Balfour Road, Parnell, Auckland 1052
Country 81668 0
New Zealand
Phone 81668 0
+64 210 728 575
Fax 81668 0
Email 81668 0
jon@strategyplus.nz

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