Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Asthma
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Treatment sequence will be randomly assigned as either test treatment followed by matching placebo or vice-versa.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 12 years and 125 years
Gender
Both males and females

Description

PrecISE is a clinical study sponsored by the U.S. National Heart, Lung, and Blood Institute (NHLBI) to investigate several treatments for severe asthma. PrecISE will enroll 800 adults and teenagers (ages 12 years and older) with severe asthma who have symptoms that are not well-controlled on high do...

PrecISE is a clinical study sponsored by the U.S. National Heart, Lung, and Blood Institute (NHLBI) to investigate several treatments for severe asthma. PrecISE will enroll 800 adults and teenagers (ages 12 years and older) with severe asthma who have symptoms that are not well-controlled on high dose of inhaled corticosteroids including those who have frequent asthma attacks. Each person who agrees to enroll in the PrecISE study will receive several treatments for research purposes based on their type of severe asthma. The goal of PrecISE is to understand how to treat different types of severe asthma, by using precision medicine. Precision medicine is an approach that targets treatments to defined subgroups of patients who share similar characteristics, for example, patients with a certain genetic variation or patients with high number of blood eosinophils. Researchers from over 30 locations across the US, as well as sites in Canada and the United Kingdom, are involved in PrecISE.

Tracking Information

NCT #
NCT04129931
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Anastasia Ivanova University of North Carolina, Chapel Hill