Hello, I am Carla Da Silva and I work at
AstraZeneca as a Senior Principal Medical Scientist.
It is my pleasure today to be presenting the recent work performed on CompEx,
a novel Composite Exacerbation Endpoint in Asthma
to accelerate clinical development.
The work presented today was funded by
AstraZeneca, and I am a full-time employee of AstraZeneca.
Why are asthma severe exacerbations of importance?
They are important since their prevention is a key goal of treatment.
To help standardize across clinical trials,
The American Thoracic Society and
European Respiratory Society have provided a definition of severe exacerbations.
These are defined as
worsening of symptoms leading to the use of
systemic steroids and hospital admission or an emergency room visit
because of asthma requiring systemic steroids.
As defined, severe exacerbations are rare events with
annualized rates ranging from 0.2 exacerbations a year in mild asthmatics,
to 1.1 exacerbations a year for severe asthmatics.
As a consequence, clinical trials using severe exacerbation as the primary outcome are
lengthy and require large sample sizes to have
sufficient power to show differences between interventions.
That is why they are conventionally not studied until later in
6,12, and sometimes 18-month Phase 3 trials.
We, therefore, hypothesized that extending the definition of a severe exacerbation,
to include subjective measures of asthma worsening that are of clinical relevance,
should increase event rates.
Therefore, this will provide insight into the evaluation of novel and existing therapies,
not only in Phase 2,
but also in Phase 3 trials.
Additionally, the development of a tool that
predicts the effect of treatments on severe exacerbations
with reduced sample size and trial duration,
might enable more efficient drug development and approval,
bringing new drugs to market faster to asthmatic patients who need them.