A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect to asthma worsening at the end of 24 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
481
Proportion of Participants Who Experience Worsening of Asthma by Week 24
Proportion of participants who experience worsening of asthma by Week 24 as defined by at least 1 of the following: * On 2 consecutive days, morning (AM) peak expiratory flow (PEF) ≤ 75% of mean AM PEF measured over the last 7 days of the Run-in * Forced expiratory volume in 1 second (FEV1) \< 80% of baseline * Increase in rescue medication use of ≥ 6 puffs/day on 2 consecutive days compared to mean use over the last 7 days of the Run-in * Increase in Asthma Control Questionnaire 5 (ACQ-5; see Outcome Measure 2 for description) score of ≥ 0.5 compared to baseline * The occurrence of a severe asthma exacerbation (asthma attack) defined as deterioration of asthma that leads to the use of systemic corticosteroids for at least 3 days, hospitalization, or an Emergency Department visit.
Time frame: up to Week 24
Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score
The ACQ-5 is a 5-item questionnaire which has been developed as a measure of the participant's asthma control that can be quickly and easily completed. The questions are designed to be self-completed by the participant. The 5 questions enquire about the frequency and/or severity of symptoms in the prior week (nocturnal awakening, activity limitation, shortness of breath, wheeze). The response options for each of these questions consists of a zero (no impairment/limitation) to 6 (total impairment/limitation) scale.
Time frame: Baseline, Week 24
Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Pre-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.
Time frame: Baseline, Week 24
Time to First Asthma Worsening
Time to first asthma worsening is defined as the time from the date of the first dose of study treatment to the first date that any of the components of asthma worsening endpoint is met. See Outcome Measure 1 for the definition of asthma worsening.
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Clinical Research Center of Albama, LLC
Birmingham, Alabama, United States
Banner University of Arizona Medical Center
Tucson, Arizona, United States
California Allergy and Asthma Medical Group
Los Angeles, California, United States
Southern California Institute for Respiratory Diseases, Inc.
Los Angeles, California, United States
North Bay Clinical Trials, Inc
Napa, California, United States
Allergy, Asthma & Sinus Consultants, Inc
Riverside, California, United States
Integrated Research of Inland, Inc.
Riverside, California, United States
Allergy & Asthma Medical Group and Research Center, A P.C.
San Diego, California, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States
Bensch Clinical Research LLC
Stockton, California, United States
...and 107 more locations
Time frame: up to Week 24
Annualized Rate of Severe Asthma Exacerbations
A severe asthma exacerbation is defined as deterioration of asthma that leads to the use of systemic corticosteroids for at least 3 days, hospitalization, or an Emergency Department visit.
Time frame: up to Week 24
Change From Baseline to Week 24 in Post-Bronchodilator FEV1
Post-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.
Time frame: Baseline, Week 24
Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF)
AM PEF was measured by participants using an electronic diary.
Time frame: Baseline, Week 24
Percentage of Participants With a Treatment-Emergent Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a participant, whether or not considered related to study treatment. Abnormal laboratory test results or other safety assessments, including those that worsened from baseline, that were considered clinically significant in the medical and scientific judgment of the investigator were to be reported as AEs.
Time frame: From first dose of study treatment through Week 28