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Trial registered on ANZCTR


Registration number
ACTRN12616000004460
Ethics application status
Approved
Date submitted
2/12/2015
Date registered
6/01/2016
Date last updated
24/11/2020
Date data sharing statement initially provided
24/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Bioequivalence study comparing a generic formulation of budesonide nasal spray with the innovator budesonide nasal spray with a 7 day run-in period, conducted in healthy participants with a history of seasonal allergic rhinitis.
Scientific title
A sequential, randomised, double-blind, placebo-controlled, parallel group study of 14 days duration (each for test and reference) bioequivalence study of Budesonide Nasal Spray in comparison with the reference product Budesonide Nasal Spray with a 7 day placebo run-in period, conducted in healthy participants with a history of seasonal allergic rhinitis.
Secondary ID [1] 287894 0
None
Universal Trial Number (UTN)
U1111-1175-3108
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bioequivalence study conducted in healthy volunteers with a history of seasonal allergic rhinitis comparing two formulations of budesonide nasal spray 64 micrograms actuation with no health condition or problem studied.

This study is being conducted in healthy volunteers who have a history of seasonal allergic rhinitis.

Budesonide is a non-halogenated corticosteroid. Budesonide is indicated for the prophylaxis and treatment of seasonal and perennial allergic rhinitis, vasomotor rhinitis and symptomatic relief of nasal polyposis. 296775 0
Condition category
Condition code
Inflammatory and Immune System 297009 297009 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sequential, placebo controlled, parallel group study design whereby each participant receives an initial 7-day placebo run-in period to establish a baseline and to identify placebo responders. Participants who respond to the placebo will be eliminated from the study. Dosing will take place daily throughout the 7-day placebo run-in period and the 14-day double-blind randomised treatment period.

The intervention for this trial is the test formulation of budesonide (2 x 64 mcg of budesonide per nostril daily)

The placebo treatment is sodium chloride in water (Saline)

No water or food is allowed for 1 hour prior to dosing until 1 hour after dosing.

Participants are required to attend dosing at Zenith Technology during the 7 day placebo period for approximately 30 minutes each morning. Participants accepted into the treatment study will then be required to attend dosing at Zenith Technology for a further 14 days for approximately 30 minutes each morning. all dosing is monitored by a staff member to ensure dosing has been completed correctly.



Pre and post study laboratory tests will be completed to assess the health of participants along with HIV, Hepatitis and drugs of abuse testing. A skin prick test will be carried out to determine if the participant has an allergy to mixed grass pollen as well as a nasal allergen provocation test to establish the individual threshold dose to induce a response (sneezing).
Intervention code [1] 293254 0
Treatment: Drugs
Comparator / control treatment
A sequential, randomised, double-blind, placebo-controlled, parallel group study of 14 days duration (each for test and reference) bioequivalence study of Budesonide Nasal Spray in comparison with the reference product Budesonide with a 7 day placebo run-in period, conducted in healthy Participants with a history of seasonal allergic rhinitis.

The comparator/control for this trial is the innovator formulation of budesonide.
Control group
Active

Outcomes
Primary outcome [1] 296603 0
To compare the bioequivalence parameters of budesonide nasal spray (as summarised by average Total Nasal Symptom Score (TNSS) data) for the two formulations.
Timepoint [1] 296603 0
Analysis of covariance will be performed on the differences of average TNSS recorded on days 5, 6, 7 and the morning score on day 8, and average TNSS from days 12 to 21, with the average TNSS on days 5, 6, 7 and the morning score on day 8 treated as the covariate.
Secondary outcome [1] 318896 0
To determine the safety and tolerability of budesonide nasal spray determined by pre-study and post-study blood tests and any adverse effects
Timepoint [1] 318896 0
Adverse Events, if any, will be monitored and recorded twice daily at 8am and 8pm. This study will not involve the collection of blood samples for sample analysis but will involve the collection of blood for pre-screening (taken within 21 days of study day 1) and post study (taken within 7 days of the last study day). Any abnormalities found between pre and post study results will be followed up until resolution.

Eligibility
Key inclusion criteria
History of seasonal allergic rhinitis with symptoms.
Positive skin prick test to mixed grass pollen.
Free from upper respiratory tract infection during the 2 weeks prior to the study and throughout the study (including fungal organisms).
Non-smoking for at least 6 months prior to the study.
Healthy male and non-pregnant females aged between 18 and 55 years.
Body Mass Index between 18 and 33 inclusive (BMI = weight in kg/Height in m2)
Normal healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests.
Liver, kidney and cardiac function, and haematological profiles clinically acceptable to the Trial Physician.
Providing written informed consent.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any history of cardiovascular, renal, neurologic, liver or endocrine disease.
Concomitant drug therapy of any kind with the exception of prescribed hormonal contraceptives which females can continue to take..
Severe nasal infections, especially candidiasis, or a history of chronic rhinitis/polyposis, sinusitis (acute or chronic), nasal polyps or any gross anatomical abnormality sufficient to impair nasal breathing.
Participants with a history of recurrent nose bleeds.
Intolerance to inhaled budesonide.
Inability to tolerate temporary withdrawal of antihistamines.
Receipt of an investigational drug 60 days prior to the study.
Laboratory tests that deviate significantly from normal.
Female Participants who are pregnant or breastfeeding.
Participants who do not consent to their GP being contacted about any adverse results or reactions.
Participants who do not, in the opinion of the Trial Physician, understand the information and procedures of the study, in particular the study restrictions and risks involved.

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)
All formulations will be labelled as Placebo, Formulation A and B. The identification of each treatment will only be known to the Managing Director and the Section Head - Trials and Regulatory Affairs.

Each participant will be identified by a 3 digit screening number and a 2 digit subject number. The screening number will be issued once the participant has given written consent to participate in the study and the two digit subject number (randomisation number) after acceptance into the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation list will be prepared using a computer program for a balanced two-way parallel design.
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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/01/2016
Actual
25/02/2016
Date of last participant enrolment
Anticipated
31/05/2016
Actual
17/08/2016
Date of last data collection
Anticipated
Actual
14/09/2016
Sample size
Target
48
Accrual to date
Final
48
Recruitment outside Australia
Country [1] 7333 0
New Zealand
State/province [1] 7333 0
Otago

Funding & Sponsors
Funding source category [1] 292383 0
Commercial sector/Industry
Name [1] 292383 0
AFT Pharmaceuticals Ltd
Country [1] 292383 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corp Ltd
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 291073 0
None
Name [1] 291073 0
Address [1] 291073 0
Country [1] 291073 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293856 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 293856 0
Ethics committee country [1] 293856 0
New Zealand
Date submitted for ethics approval [1] 293856 0
07/10/2015
Approval date [1] 293856 0
18/12/2015
Ethics approval number [1] 293856 0
15/CEN/173

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61538 0
Dr Noelyn Hung
Address 61538 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 61538 0
New Zealand
Phone 61538 0
+6434779669
Fax 61538 0
+6434779605
Email 61538 0
[email protected]
Contact person for public queries
Name 61539 0
Linda Folland
Address 61539 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 61539 0
New Zealand
Phone 61539 0
+6434779669
Fax 61539 0
+6434779605
Email 61539 0
[email protected]
Contact person for scientific queries
Name 61540 0
Tak Hung
Address 61540 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 61540 0
New Zealand
Phone 61540 0
+6434779669
Fax 61540 0
+6434779605
Email 61540 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data is compiled into a final report that is the property of the sponsor company. All participant data is provided in summary format and result of the study only will be reported


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.