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Trial registered on ANZCTR


Registration number
ACTRN12610000515099
Ethics application status
Approved
Date submitted
9/06/2010
Date registered
22/06/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to investigate the "real-life" use of the Vannair "SMART" regime in adult asthma (the SMART study).
Scientific title
A randomised, controlled trial to investigate the "real-life" use of the Vannair "SMART" regime in adult asthma (the SMART study)
Secondary ID [1] 251981 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 256688 0
Condition category
Condition code
Respiratory 256844 256844 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is inhaled budesonide/eformoterol (Vannair (Registered Trademark) 200/6 micrograms) two actuations taken twice daily and as required for asthma symptom relief as per the "SMART" (Single combination inhaler as Maintenance And Reliever Therapy) regime. The duration of the intervention is 24 weeks. There is no subsequent follow-up period planned.
Intervention code [1] 255920 0
Treatment: Drugs
Comparator / control treatment
The control is inhaled budesonide/eformoterol (Vannair (Registered Trademark) 200/6 micrograms) two actuations taken twice daily along with a salbutamol inhaler (Ventolin (Registered Trademark) 100 micrograms) taken as required for asthma symptom relief (the "Standard" treatment regime). The duration of the control treatment is 24 weeks. There is no subsequent follow-up period planned.
Control group
Active

Outcomes
Primary outcome [1] 257710 0
The proportion of high beta-agonist use episodes in the SMART group compared with the Standard Group as defined by the proportion of patients in the SMART group who at any point within the 24 week study period used greater than 8 actuations of Vannair as a reliever per 24 hour period compared to the proportion of patients in the Standard group who used greater than 16 actuations of Ventolin in a 24 hour period, as recorded by the electronic monitoring devices.
Timepoint [1] 257710 0
As assessed after the 24 week study period on the data from the electronic monitoring devices.
Secondary outcome [1] 263057 0
Asthma Control Questionnaire (ACQ) Score
Timepoint [1] 263057 0
As assessed after 24 weeks of treatment and compared with the baseline score.
Secondary outcome [2] 263058 0
The proportion of patients in the SMART group who markedly overuse Vannair as a reliever (defined as greater than 12 and 16 reliever actuations per 24 hour period) compared with Standard group patients who markedly overuse salbutamol as a reliever (defined as greater than 24 and 32 Ventolin actuations per 24 hour period respectively), as recorded by the electronic monitoring devices.
Timepoint [2] 263058 0
As assessed after the 24 week study period on the data from the electronic monitoring devices.
Secondary outcome [3] 263059 0
The proportion of patients who underuse their maintenance Vannair treatment in the SMART versus Standard groups, defined as 0 or 1 inhalations within a 24 hour period, as recorded by the electronic monitoring devices.
Timepoint [3] 263059 0
As assessed after the 24 week study period on the data from the electronic monitoring devices.
Secondary outcome [4] 263060 0
Patterns of use of reliever Vannair and salbutamol around the time of exacerbations. Exacerbation data will be recorded from patients at study visits and patterns of use of reliever medication will be obtained from the electronic monitoring devices.
Timepoint [4] 263060 0
As assessed from data collected at the time of study visits over the 24 weeks of treatment.
Secondary outcome [5] 263061 0
Number of severe exacerbations in the SMART versus Standard groups. Exacerbation data will be recorded from patients at study visits.
Timepoint [5] 263061 0
As assessed from data collected at the time of study visits over the 24 weeks of treatment.

Eligibility
Key inclusion criteria
1. A doctor's diagnosis of asthma; 2. A current prescription for inhaled corticosteroid (ICS) medications; 3. No change in the dose of ICS in the last month; 4. An asthma exacerbation in the previous year where the patient presented to a General Practitioner or Emergency Department and was prescribed a course of oral steroids and/or received a spacer/nebuliser-delivered bronchodilator and patients who self-administered prednisone for asthma for at least 3 days.
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Onset of respiratory symptoms after the age of 40 years in current or ex-smokers with a greater than or equal to 10 pack years smoking history; 2. use of an at-home nebuliser (unless patients agree to withhold nebuliser use for the study duration); 3. treatment with oral prednisone in the previous 4 weeks; 4. diagnosis of Chronic Obstructive Pulmonary Disease (COPD), interstitial lung disease or bronchiectasis; 5. unsuitable cardiovascular or other medical history, or any other safety concern at the investigator's discretion; 6. unable or unwillling to give consent to participate, to follow the study requirements and/or to change from current asthma treatment regime.

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)
Investigators will screen patients for eligibility for entry into the study at Visit 1. If found eligible, allocation concealment will occur by means of sealed opaque envelope, containing details of allocation to the SMART or Standard study group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed in blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 2444 0
New Zealand
State/province [1] 2444 0

Funding & Sponsors
Funding source category [1] 256420 0
Government body
Name [1] 256420 0
Health Research Council of New Zealand
Country [1] 256420 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Private Bag 7902
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 255723 0
None
Name [1] 255723 0
Address [1] 255723 0
Country [1] 255723 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258471 0
Multi Region Ethics Committee
Ethics committee address [1] 258471 0
Ministry of Health
Level 2, 1-3 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 258471 0
New Zealand
Date submitted for ethics approval [1] 258471 0
29/10/2009
Approval date [1] 258471 0
12/05/2010
Ethics approval number [1] 258471 0
MEC/09/11/127

Summary
Brief summary
The recommended treatment for preventing asthma exacerbations in adults with moderate-severe asthma is regular inhaled corticosteroids (ICS) combined with an inhaled long-acting beta-agonist drug (LABA). This therapy is commonly prescribed as a fixed combination inhaler, such as Seretide (Registered Trademark), Symbicort (Registered Trademark) or Vannair (Registered Trademark) and is taken twice daily with a short-acting beta-agonist (SABA) used as rescue therapy in the event of an exacerbation ("STANDARD" regime). An alternative regime in which patients take their Vannair (Registered Trademark) combination inhaler both as Maintenance And Reliever Therapy (referred to as SMART) has recently been proposed. A large clinical trial programme has shown that Symbicort (Registered Trademark) (budesonide/eformoterol) taken according to the SMART regime is more effective than the STANDARD regime. However, these studies were undertaken under strict clinical trial conditions in highly selected populations. Additionally it is not clear how the use of budesonide/eformoterol given according to the SMART regime improves outcomes, or whether its use by patients in the situation of worsening asthma or severe exacerbations is associated with significant risk.
This study aims to assess the effect on asthma control of budesonide/eformoterol given using the SMART regime in a population of high-risk asthmatics in real life and to measure (using electronic monitoring devices) the actual use of budesonide/eformoterol when used according to the SMART regime.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30772 0
Address 30772 0
Country 30772 0
Phone 30772 0
Fax 30772 0
Email 30772 0
Contact person for public queries
Name 14019 0
Dr Mitesh Patel
Address 14019 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 14019 0
New Zealand
Phone 14019 0
+64 4 805 0235
Fax 14019 0
+64 4 389 5707
Email 14019 0
[email protected]
Contact person for scientific queries
Name 4947 0
Dr Mitesh Patel
Address 4947 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 4947 0
New Zealand
Phone 4947 0
+64 4 805 0235
Fax 4947 0
+64 4 389 5707
Email 4947 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AIShort-Acting ß-Agonist Use As a Marker of Current Asthma Control2013https://doi.org/10.1016/j.jaip.2013.04.008
EmbasePredictors of Severe Exacerbations, Poor Asthma Control, and beta-Agonist Overuse for Patients with Asthma.2014https://dx.doi.org/10.1016/j.jaip.2014.06.001
Dimensions AIEffect of smoking status on the efficacy of the SMART regimen in high risk asthma2016https://doi.org/10.1111/resp.12740
EmbaseSMART for the treatment of asthma: A network meta-analysis of real-world evidence.2021https://dx.doi.org/10.1016/j.rmed.2021.106611
N.B. These documents automatically identified may not have been verified by the study sponsor.