People with mild-to-moderate asthma can often rely on common inhalers to treat their symptoms. But those with a severe form of the disease find it more difficult to control, even with higher doses of medication.
Although researchers across the world are developing better treatments for severe asthma, they often use different tools to assess how well they work (the outcomes). This makes it difficult to compare or combine results of any research on the condition.
“Different studies use different outcomes, and then it's impossible to compare the results between studies,” says Professor Graham Roberts of the University of Southampton, UK. “For example, we cannot see whether the same drug works equally well in different studies, but even more importantly, we can't compare how different drugs work because all the trials use different outcomes.”
Until now, asthma researchers have not used a consistent, standard set of results (called core outcome measures) to understand whether or not certain asthma therapies work. To remedy this, a European multi-stakeholder working group has developed the 'core outcome measures sets for paediatric and adult severe asthma' (COMSA). By having a minimum set of outcome measures for all future clinical trials, the hope is that COMSA will speed up finding which treatment works best for individuals with severe asthma.
The work on COMSA was led by the Innovative Medicines Initiative (IMI) project 3TR, which is analysing data and samples of seven diseases, including severe asthma, from over 50 000 patients to find which factors determine if a patient will respond well to certain treatment. The working group that created COMSA was made up of doctors, people both young and old living with severe asthma, patient representatives, pharmaceutical companies, and health policymakers.
To develop COMSA, the working group looked at what individual outcome measures were being used in severe asthma research, for example ways of measuring changes in lung function during a clinical trial. It also surveyed patients living with severe asthma and their carers across Europe
Involving patients and their representatives was crucial to developing COMSA, says Prof. Roberts. “Medical research is undertaken to improve the management of patients with diseases. If we are to achieve this, it's critical that we understand what patients find most burdensome and how they view their response to specific therapies.”
It was representatives from these key groups that voted for which tools should be included in COMSA.
The full COMSA set of core outcome measures includes measures of lung function, frequency and severity of severe asthma attacks, and regular steroid tablet use. It also includes standards for patient-reported outcomes, such as asthma control questionnaires and asthma quality of life questionnaires for adults and children.
Prof. Graham says that the project is now looking at quantifying the response to treatment with biological therapies in severe asthma. “We are using the core outcome data set as the basis for this and involving experienced clinicians, researchers and patients in the work,” he said. “The aim is to develop a system that will help us to evaluate the extent to which patients respond to different biological therapies.”
3TR is supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry.