Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000966897
Ethics application status
Approved
Date submitted
6/09/2012
Date registered
7/09/2012
Date last updated
19/07/2019
Date data sharing statement initially provided
19/07/2019
Date results information initially provided
19/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a simple asthma ‘step-up’ regime based on the Asthma Control Test (ACT) score improve asthma outcomes? A pilot study.
Scientific title
Does a simple asthma ‘step-up’ regime based on the Asthma Control Test (ACT) score improve asthma outcomes? A pilot study.
Secondary ID [1] 281183 0
ACT01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 287358 0
Condition category
Condition code
Respiratory 287688 287688 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of the ACT (Asthma Control Test) to guide an increase in asthma therapy. If ACT score is below 20, treatment is increased for 3 months. Treatment is in the form of asthma inhalers, and the investigators have discretion as to which drugs/doses are used
Intervention code [1] 285638 0
Treatment: Drugs
Comparator / control treatment
Participants act as their own historical controls, with the first 3 monhs of the trial being the control period.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287933 0
Change in ACT score from baseline
Timepoint [1] 287933 0
End of study (6 months)
Secondary outcome [1] 299080 0
Proportion of patients with severe asthma exacerbations. Assessed by asking the participant
Timepoint [1] 299080 0
End of study (6 months)
Secondary outcome [2] 299081 0
Number of severe asthma exacerbations. Assessed by asking the participant
Timepoint [2] 299081 0
End of study (6 months)

Eligibility
Key inclusion criteria
Doctor diagnosis of asthma
Aged 16-55
ACT score of less than or equal to 19 out of 25
Prescription of a short acting bronchodilator, or an inhaled corticosteroid (ICS) plus short acting bronchodilator
Minimum age
16 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Treatment with long acting beta agonist (LABA)
A diagnosis of COPD, bronchiectasis or pulmonary fibrosis
Any other safety concern at the Investigator’s discretion
Inability to understand the study requirements and/or give informed consent to participate

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)
Open-label
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/09/2012
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
1/01/2014
Date of last data collection
Anticipated
Actual
30/06/2014
Sample size
Target
100
Accrual to date
Final
93
Recruitment outside Australia
Country [1] 4534 0
New Zealand
State/province [1] 4534 0

Funding & Sponsors
Funding source category [1] 285955 0
Commercial sector/Industry
Name [1] 285955 0
GlaxoSmithKline
Country [1] 285955 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Amp Centre Level 8/29 Customs Street West Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 284778 0
None
Name [1] 284778 0
Address [1] 284778 0
Country [1] 284778 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287989 0
Northern A
Ethics committee address [1] 287989 0
Not known
Ethics committee country [1] 287989 0
New Zealand
Date submitted for ethics approval [1] 287989 0
Approval date [1] 287989 0
28/08/2012
Ethics approval number [1] 287989 0
12/NTA/4

Summary
Brief summary
Asthma outcomes are poor, despite effective medications. Patients are often satisfied with their asthma despite poor control; this satisfaction with their level of control is reported to their GP, and therefore there is often no driver towards an increase in medication.
Asthma control assessment by GPs is currently subjective; GPs are more likely to recognise the need to change treatment if they use an objective measure
The Asthma Control Test (ACT) score is a simple, objective measure of asthma control, not commonly used by New Zealand GPs
ACT scores of less than or equal to 19 reflect poorly controlled asthma and scores greater than or equal to 20 reflect controlled asthma.

The aim of the study is to see if a simple asthma "Step-Up" regime based on the objective ACT Score improves asthma outcomes
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34680 0
Dr Shaun Holt
Address 34680 0
Victoria University of Wellington
PO Box 600. Wellington 6140
Country 34680 0
New Zealand
Phone 34680 0
+64292001111
Fax 34680 0
Email 34680 0
[email protected]
Contact person for public queries
Name 17927 0
Dr Shaun Holt
Address 17927 0
100 Munro Road, Te Puna, RD7. Tauranga 3179
Country 17927 0
New Zealand
Phone 17927 0
+64 29 200 11 11
Fax 17927 0
Email 17927 0
[email protected]
Contact person for scientific queries
Name 8855 0
Dr Shaun Holt
Address 8855 0
100 Munro Road, Te Puna, RD7. Tauranga 3179
Country 8855 0
New Zealand
Phone 8855 0
+64 29 200 11 11
Fax 8855 0
Email 8855 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Holt S, Patel M, Weatherall M, Beasley R, Montgome... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCohort study of a simple 'Step-Up' regimen with the Asthma Control Test.2015https://dx.doi.org/10.1111/resp.12468
N.B. These documents automatically identified may not have been verified by the study sponsor.