The precision interventions for severe and/or exacerbation-prone asthma (PrecISE) adaptive platform trial:...

Area of Science:

• Clinical Trials
• Respiratory Medicine
• Precision Medicine

Background:

• Severe asthma affects millions, often inadequately managed by current therapies.
• Exacerbation-prone asthma requires novel treatment strategies.
• Precision medicine offers a promising avenue for tailoring interventions.

Purpose of the Study:

• To investigate novel interventions for severe and/or exacerbation-prone asthma.
• To implement a master protocol for an adaptive platform trial.
• To utilize precision health methods for personalized treatment assignments.

Main Methods:

• Adaptive platform trial with a crossover design.
• Master protocol allowing for multiple interventions per participant.
• Biomarker-based treatment assignment and precision health analysis.
• Multistage adaptive enrichment strategy and futility stopping rules.

Main Results:

• The study design incorporates adaptive enrichment and futility stopping.
• Power calculations and primary analysis strategies are detailed.
• Interim and final analyses leverage precision health methods.

Conclusions:

• The PrecISE study employs a robust adaptive platform design for severe asthma research.
• Biomarker-driven interventions and precision health methods are central to the trial.
• The study aims to advance personalized treatment approaches for severe asthma.