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Trial registered on ANZCTR


Registration number
ACTRN12615000634572
Ethics application status
Approved
Date submitted
26/05/2015
Date registered
18/06/2015
Date last updated
5/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An Assessment of Citramel in Healthy Volunteers
Scientific title
A Open-label Assessment of the Safety of Citramel in Healthy Volunteers
Secondary ID [1] 286430 0
Nil
Universal Trial Number (UTN)
U1111-1154-7443
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 294598 0
Condition category
Condition code
Respiratory 294900 294900 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 295471 295471 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Citramel - an aqueous solution of sodium citrate (16.18 mg/mL), citric acid (0.046 mg/mL) and ammonium chloride (4.12 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] 291508 0
Treatment: Drugs
Comparator / control treatment
No comparator group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294655 0
Safety as assessed by Adverse events, Vital signs, spirometry and Laboratory Tests
Timepoint [1] 294655 0
Screening and/or Baseline, then weekly to Day 28
Primary outcome [2] 294656 0
Participant diary records daily tolerability assessments during the study medication administration phase
Timepoint [2] 294656 0
Daily from baseline to Day 28
Secondary outcome [1] 315192 0
No secondary outcomes
Timepoint [1] 315192 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 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; current or previously clinically significant smoking history; 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.

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)
After obtaining consent and confirming eligibility, the participant will be enrolled in the study. It is an open label assessments of Citramel in 5 healthy volunteers.
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
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety
Statistical methods / analysis
This is a Phase 1 safety assessment of Citramel in 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
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 outside Australia
Country [1] 6778 0
New Zealand
State/province [1] 6778 0
Canterbury

Funding & Sponsors
Funding source category [1] 291001 0
Commercial sector/Industry
Name [1] 291001 0
Breathe Easy Ltd
Address [1] 291001 0
Ground Floor, Shed 20,
139 Quay Street,
Princes Wharf
Auckland 1010
Country [1] 291001 0
New Zealand
Funding source category [2] 291097 0
Government body
Name [2] 291097 0
NZVIF (New Zealand Venture Investment Fund)
Address [2] 291097 0
Unit 1B, Ascot Office Park, 93-95 Ascot Ave
Greenlane, Auckland 1051, New Zealand
Country [2] 291097 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Breathe Easy Ltd
Address
Ground Floor, Shed 20,
139 Quay Street,
Princes Wharf
Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 289679 0
None
Name [1] 289679 0
Address [1] 289679 0
Country [1] 289679 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292586 0
Central Health and Disability Ethics Committee.
Ethics committee address [1] 292586 0
1 The Terrace
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 292586 0
New Zealand
Date submitted for ethics approval [1] 292586 0
Approval date [1] 292586 0
01/07/2014
Ethics approval number [1] 292586 0
14/CEN/89

Summary
Brief summary
This is a research study to evaluate Citramel inhalation. The study is an open label administration of Citramel to 5 healthy volunteers to evaluate safety and tolerability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56106 0
Dr Chris Wynne
Address 56106 0
Christchurch Clinical Studies Trust (CCST)
31 Tuam Street
Christchurch 8011
Country 56106 0
New Zealand
Phone 56106 0
+64 3 372 9477
Fax 56106 0
+64 3 372 9478
Email 56106 0
Chris@ccst.co.nz
Contact person for public queries
Name 56107 0
Ms Andrea Miller
Address 56107 0
Breathe Easy Ltd, C/- Pacific Channel Ltd
Ground Floor, Shed 20,
Equinox House,
139 Quay Street,
Princes Wharf
Auckland 1010
Country 56107 0
New Zealand
Phone 56107 0
+64 9 377 9689
Fax 56107 0
Email 56107 0
andreajmiller@gmail.com
Contact person for scientific queries
Name 56108 0
Ms Andrea Miller
Address 56108 0
Breathe Easy Ltd, C/- Pacific Channel Ltd
Ground Floor, Shed 20,
Equinox House,
139 Quay Street,
Princes Wharf
Auckland 1010
Country 56108 0
New Zealand
Phone 56108 0
+64 9 377 9689
Fax 56108 0
Email 56108 0
andreajmiller@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