Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001387112
Ethics application status
Approved
Date submitted
23/09/2019
Date registered
10/10/2019
Date last updated
9/08/2022
Date data sharing statement initially provided
10/10/2019
Date results provided
26/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A study comparing the speed of airway dilatation following a single dose of salbutamol versus a single dose of symbicort in adult asthmatics
Scientific title
Speed of bronchodilator onset at 2 minutes after a single rescue dose of budesonide/formoterol Turbuhaler vs salbutamol pMDI in adult asthmatics.
Secondary ID [1] 299314 0
Nil
Universal Trial Number (UTN)
U1111-1236-7263
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 314450 0
Bronchodilation 314451 0
Condition category
Condition code
Respiratory 312785 312785 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm: Budesonide/formoterol 200/6mcg, one actuation
Spirometry will be condcuted at baseline, 1,2,3,5,10,15 and 30 minutes post dose.
Visual Analogue Score administered at 1,2,3,5,10,15 and 30 minutes post dose
mBORG Scale administered at baseline and 10 minutes.

Total duration will be approximately 1 hour and will be conducted at the Medical research Institute of New Zealand (MRINZ)

The study drugs will be administered by a study investigator and therefore there is no need to monitor adherence.
An actuation is defined as an 'inhalation or puff from an inhaler'.
Due to the cross over design, there will be a washout period of 7 days
Intervention code [1] 315581 0
Treatment: Drugs
Comparator / control treatment
Comparator arm: Salbutamol 100mcg, 2 actuations.
Intervention arm: Symbicort 200/6mcg 1 actuation
Control group
Active

Outcomes
Primary outcome [1] 321403 0
FEV1 measured by spirometry
Timepoint [1] 321403 0
at 2 minutes
Secondary outcome [1] 374884 0
To determine the time course of bronchodilator effect over 30 minutes measured by spirometry.
Timepoint [1] 374884 0
FEV1 at 1, 2, 3, 5, 10, 15 and 30 minutes.
Secondary outcome [2] 374885 0
To measure perceived bronchodilator effect over 30 minutes.
Timepoint [2] 374885 0
VAS Questionnaire administered at 1, 2, 3, 5, 10, 15 and 30 minutes.
Secondary outcome [3] 375651 0
mBorg questionnaire to measure percieved shortness of breath
Timepoint [3] 375651 0
mBorg administered prior to intervention and again at 10 and 30 minutes post dose

Eligibility
Key inclusion criteria
• Self-reported doctor diagnosis of asthma.
• Age 18 to 65 years at time of consent.
• Allowed asthma treatments are SABA as reliever, regular maintenance ICS therapy together with SABA as a reliever, regular maintenance ICS , LABA with SABA as a reliever or ICS/LABA as a reliever.
• FEV1 greater than 50% predicted using the GLI2012 predicted values at the screening visit.
• Change in FEV1 within 30 minutes of 200mcg salbutamol being administered must be at least 10% and at least 200ml improvement from baseline in FEV1.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Other clinically significant respiratory or cardiovascular disorder.
• Current or recent respiratory tract infection not resolved within the 4 weeks prior to the randomisation visit.
• Current or intermittent use of LTRA therapy, LAMA, SAMA, theophylline, biologics, sodium cromoglycate or nedocromil sodium or non-selective beta blockers within 4 weeks of randomisation.
• Asthma exacerbation requiring oral steroids within the 6 weeks prior to the randomistaion visit.
• Ex-smokers or current smokers with a history >10 pack years.
• Pregnant, or planning a pregnancy, or breast feeding.
• Allergy or contraindication to investigational products.
• Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.
• Unable to perform spirometry.
• Unable to use correct inhaler technique at both screening and prior to intervention 1.
• Unable to withhold usual asthma medications prior to screening and each intervention.

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)
Following the screening process, eligible participants who have given written consent to be enrolled in the study will be randomised 1:1 to one of the treatment arms. The allocations will be concealed and a participant’s randomisation outcome will only be released at the time of randomisation. Allocation was by central randomisation done by a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation method will involve a computer-generated sequence supplied by the study statistician, independent of the investigators. The sequence will be uploaded into the Research Electronic Data Capture (REDCap) system by an individual who is otherwise uninvolved in study processes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Efficacy
Statistical methods / analysis
The primary outcome will be FEV1 at 2 minutes. A mixed linear model will be used with the baseline FEV1, treatment allocation, and treatment order as fixed effects; and participant treated as a random effect to take into account the cross-over design. For the FEV1 at other measurement times a time by treatment interaction will be fitted and if statistically significant individual time-wise comparisons will be estimated between treatments.

In a feasibility study the SD for paired FEV1 measurements was about 160mL (at both 2 and 5 minutes).
The non-inferiority bounds were set between plus or minus 60mL equivalent to 25% of the minimal ` perceivable improvement of 230mL9.
The feasibility study was a cross-over design, with a paired t-test assessment for the difference, at 80% power and alpha of 5%, 46 participants are needed based on a paired SD of 160mL. To allow for an 8% dropout rate 50 subjects will be recruited.
Significance of P<0.05 is set for the primary outcome variable.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study stopped after recruitment of 49 participants. Study medication expired on June 30th 2020 and last participant could not be completed due to COVID-19 Alert Level changes in New Zealand and COVID-19 guidance.
Date of first participant enrolment
Anticipated
21/10/2019
Actual
24/01/2020
Date of last participant enrolment
Anticipated
31/03/2021
Actual
21/06/2021
Date of last data collection
Anticipated
14/04/2021
Actual
23/06/2021
Sample size
Target
50
Accrual to date
Final
49
Recruitment outside Australia
Country [1] 21864 0
New Zealand
State/province [1] 21864 0
Wellington

Funding & Sponsors
Funding source category [1] 303833 0
Other
Name [1] 303833 0
The Medical Research Institute of New Zealand
Country [1] 303833 0
New Zealand
Primary sponsor type
Other
Name
The Medical Research Institute of New Zealand
Address
Level 7, CSB, Wellington hospital, Riddiford St, Newtown, Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 303960 0
None
Name [1] 303960 0
Address [1] 303960 0
Country [1] 303960 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304348 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 304348 0
Ethics committee country [1] 304348 0
New Zealand
Date submitted for ethics approval [1] 304348 0
29/08/2019
Approval date [1] 304348 0
20/09/2019
Ethics approval number [1] 304348 0
19/STH/170

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

Contacts
Principal investigator
Name 96634 0
Prof Richard Beasley
Address 96634 0
MRINZ Level 7 CSB Wellington hospital Riddiford St Newtown Wellington 6021
Country 96634 0
New Zealand
Phone 96634 0
+64 48050238
Fax 96634 0
+64 43895707
Email 96634 0
[email protected]
Contact person for public queries
Name 96635 0
Richard Beasley
Address 96635 0
MRINZ Level 7 CSB Wellington hospital Riddiford St Newtown Wellington 6021
Country 96635 0
New Zealand
Phone 96635 0
+64 48050238
Fax 96635 0
+64 43895707
Email 96635 0
[email protected]
Contact person for scientific queries
Name 96636 0
Richard Beasley
Address 96636 0
MRINZ Level 7 CSB Wellington hospital Riddiford St Newtown Wellington 6021
Country 96636 0
New Zealand
Phone 96636 0
+64 48050238
Fax 96636 0
+64 43895707
Email 96636 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who provide a methodologically sound proposal that has been approved by the study steering committee.


Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data that underlie the results reported in this article, after de­ identification (text, tables, figures, and appendices).

What types of analyses could be done with individual participant data?
• To achieve the aims outlined in the approved proposal.


When can requests for individual participant data be made (start and end dates)?
From:
One year after publication until a minimum of 5 years after publication.


To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Through a signed data access agreement. The agreement can be obtained by emailing the Principal Investigator: [email protected].

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4841Study protocol    file attached Study-related document.docx
4842Informed consent form    file attached Study-related document.doc
5028Ethical approval    file attached Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSingle dose of budesonide/formoterol turbuhaler compared to salbutamol pMDI for speed of bronchodilator onset in asthma: A randomised cross-over trial.2023https://dx.doi.org/10.1136/thorax-2022-219052
N.B. These documents automatically identified may not have been verified by the study sponsor.