The PRACTICAL Trial
The PRACTICAL trial is a randomised controlled study of combined reliever/preventer medication for intermittent or mild asthma. A 52- week, open label, parallel group, multi-centre, phase III, randomised controlled trial to compare the efficacy and safety of two asthma treatment regimens. Recruitment in New Zealand only.
The PRACTICAL Trial
Background
- We have particularly high rates of asthma in New Zealand
- Regular use of ICS reduces symptoms, improves lung function, reduces severe exacerbations, prevents hospital admissions, and reduces the risk of mortality. However, the benefits of ICS in clinical practice are limited by poor adherence
Facts
- Asthma is a major public health problem in New Zealand with between 15% to 20% of children and adults having asthma
- There are over 6,000 hospital admissions due to asthma in NZ annually
- The economic costs of asthma were estimated to be around NZ$825 million per year in the late 1990s
Aims
Primary: to compare the efficacy of the ICS/fast-onset LABA reliever therapy regimen with the ICS maintenance and SABA reliever therapy regimen in adult patients with asthma in whom the ICS maintenance and SABA reliever therapy regimen is recommended.
Secondary:
- To compare the safety of the ICS/fast-onset LABA reliever therapy regimen with the ICS maintenance and SABA reliever therapy regimen.
- To determine whether baseline clinical and socioeconomic characteristics such as reported beta agonist use, Th2 profile, smoking status, history of severe exacerbations or housing status predict preferential response to randomised treatments.
- To examine patterns of inhaler use with the randomised treatments.
- To examine the cost effectiveness of the randomised treatments.
- To examine patient attitudes to the treatment regimens.
Methods
- 900 patients will be randomised to receive one of two inhaler regimens for one year
- Eligible patients will be randomised 1:1 to receive either a Symbicort inhaler for relief of symptoms when needed, or a regular preventer Pulmicort inhaler and Bricanyl inhaler for relief of symptoms
- Participants will be seen for the initial visit (week 0) and at weeks 4, 16, 28, 40 and 52
- Participants will be recruited from sites throughout New Zealand
About the software for this project
- This trial was very similar, in structure and datapoints, to the previously developed NovelSTART trial
- We were able to copy our software iteration of the NovelSTART trial and, with suitable modifications, supply Spinnaker for this study at a fraction of the cost of its donor study.
Supporters:
- The Medical Research Institute of New Zealand
- The Health Research Council of New Zealand
- Genentech
Coordinating centre: The Medical Research Institute of New Zealand
Chief Investigator: Professor Richard Beasley, Medical Research Institute of New Zealand, Wellington, New Zealand
Contact: Mark Holliday, Clinical Trials Manager, Medical Research Institute of New Zealand
Software: Spinnaker, from Spiral Software
“It’s really hard to find anything that Spiral could have done better during the project. We look forward to seeing the same high quality results in NovelSTART and Practical as we did in the HEAT trial.”
Mark Holliday, Clinical Trials Manager,
The Medical Research Institute of New Zealand