The goal of this clinical trial\] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥18 years, on Global Initiative for Asthma (GINA) 2021 \[GINA, 2021\] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
509
Oral administration of dexpramipexole tablet
Number and Percentage of Participants with a Treatment Emergent Adverse Event
Summary of participants from the safety population who experienced an adverse event.
Time frame: 52 weeks
Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations
Summary of participants from the safety population who experienced potentially clinically significant postbaseline changes in hematology and chemistry results.
Time frame: 52 weeks
Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight
Summary of participants from the safety population who experienced potentially clinically significant postbaseline changes in vital signs (blood pressure, pulse rate, respiratory rate, and temperature) or body weight.
Time frame: 52 weeks
Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters
Summary of participants from the safety population who experienced potentially significant postbaseline changes in electrocardiogram parameters: heart rate, PR, QRS and QTcF intervals.
Time frame: 52 weeks
Severe Asthma Exacerbations
Annualized rate of severe asthma exacerbations over 52 weeks
Time frame: Averaged across 52 weeks
Change in Asthma Control Questionnaire-6 (ACQ-6)
ACQ-6 is simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. The 6-point self-administered scale has items measuring asthma symptoms and rescue inhaler use. The ACQ score is the mean of the questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
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Research Site 20001-374
Bakersfield, California, United States
Research Site 20001-376
Northridge, California, United States
Research Site 20001-029
Coral Gables, Florida, United States
Research Site 20001-014
Greenacres City, Florida, United States
Research Site 30001-291
Jacksonville, Florida, United States
Research Site 20001-066
Miami, Florida, United States
Research Site 20001-001
Miami, Florida, United States
Research Site 20001-311
Miami, Florida, United States
Research Site 20001-026
Miami, Florida, United States
Research Site 30001-082
Miami, Florida, United States
...and 93 more locations
Time frame: Day 1 (baseline), Weeks 16, 32, and 52
Change in absolute eosinophil counts (AEC)
Change from baseline, at Weeks 16, 32, and 52.
Time frame: Day 1 (baseline), Weeks 16, 32, and 52