The primary objective of the study is to evaluate the effect of TEV-48574 compared with placebo on loss of asthma control (LoAC) in adult participants with T2-low and non-T2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA). The secondary efficacy objective is to evaluate the effect of TEV-48574 compared with placebo on a range of clinical measures of asthma control. The duration of participant participation in the study is planned to be up to approximately 30 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
Number of Participants Who Experienced Loss of Asthma Control (LoAC) During the Treatment Period
The LoAC was defined as any 1 of the following during the treatment period: - morning peak expiratory flow (PEF) decrease ≥30% from baseline on 2 consecutive days or morning handheld forced expiratory volume in the first second of exhalation (FEV1) decrease ≥20% from baseline on 2 consecutive days; - increase in short-acting beta-agonist (SABA)/quick-relief medication ≥6 puffs over baseline use in 24 hours on 2 consecutive days; increase in inhaled corticosteroids (ICS) dose ≥4 × most recent dose; - systemic corticosteroid use; - asthma emergency room (ER) visit or hospitalization.
Time frame: From randomization (Week 0) until Week 16
Time From Randomization to LoAC During the Treatment Period
Time (in days) from randomization to LoAC during the treatment period is the interval from randomization to the occurrence of the LoAC. The LoAC was defined as any 1 of the following during the treatment period: - morning PEF decrease ≥30% from baseline on 2 consecutive days or morning handheld FEV1 decrease ≥20% from baseline on 2 consecutive days; - increase in SABA/quick-relief medication ≥6 puffs over baseline use in 24 hours on 2 consecutive days; increase in ICS dose ≥4 × most recent dose; - systemic corticosteroid use; - asthma ER visit or hospitalization.
Time frame: From randomization (Week 0) until Week 16
Change From Baseline in Asthma Control Questionnaire 6-Question Version (ACQ-6) Score at Week 16
The ACQ-6 is a 6-item validated asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ-6 has a possible score ranges from 0 to 6, and the total score is the mean of all responses. The total score ranging from 0-6 (0=totally controlled and 6=severely uncontrolled). A higher score indicated poorer asthma control.
Time frame: Baseline, Week 16
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Teva Investigational Site 14884
Birmingham, Alabama, United States
Teva Investigational Site 14915
Little Rock, Arkansas, United States
Teva Investigational Site 14914
Bakersfield, California, United States
Teva Investigational Site 15234
Huntington Beach, California, United States
Teva Investigational Site 14896
Los Angeles, California, United States
Teva Investigational Site 14918
Los Angeles, California, United States
Teva Investigational Site 14913
Los Angeles, California, United States
Teva Investigational Site 14910
Rolling Hills Estates, California, United States
Teva Investigational Site 14907
San Diego, California, United States
Teva Investigational Site 14891
San Jose, California, United States
...and 87 more locations
Change From Baseline in Percent Predicted Forced Expiratory Volume in the First Second (FEV1) at Week 16
FEV1 (measured by handheld spirometer) is the volume of air that can be forcibly exhaled from the lungs in the first second. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%.
Time frame: Baseline, Week 16
Change From Baseline in Daily Average Use of Short-acting Beta-agonist (SABA) Quick Relief Medication at Week 16
Number of inhalations/puffs of SABA/quick relief inhaler used was recorded in the e-diary daily.
Time frame: Baseline, Week 16
Number of Participants Who Had a Clinical Asthma Exacerbation (CAE) During the Treatment Period
The CAEs during the study were defined as a worsening of asthma symptoms resulting in any 1 of the following: - the use of systemic corticosteroids (oral or injectable); - an emergency department visit due to asthma treated with systemic corticosteroids; - an inpatient hospitalization due to asthma. Worsening asthma included new or increased symptoms or signs that either worried the participant or were related to an asthma-specific alert (if available through the e-diary/handheld spirometer).
Time frame: From randomization (Week 0) until Week 16
Time From Randomization to First CAE During the Treatment Period for Participants With CAE
The CAEs during the study were defined as a worsening of asthma symptoms resulting in any 1 of the following: - the use of systemic corticosteroids (oral or injectable); - an emergency department visit due to asthma treated with systemic corticosteroids; - an inpatient hospitalization due to asthma. Worsening asthma included new or increased symptoms or signs that either worried the participant or were related to an asthma-specific alert (if available through the e-diary/handheld spirometer).
Time frame: From randomization (Week 0) until Week 16
Change From Baseline in Number of Nighttime Awakenings Due to Asthma at Week 16
Participants recorded the number of nighttime awakenings due to asthma in the e-diary daily, in the morning.
Time frame: Baseline, Week 16
Percent Change in ICS Dose During the Treatment Period
The ICS dose was not collected in the participant diary as planned.
Time frame: From randomization (Week 0) until Week 16
Change From Baseline in Forced Vital Capacity (FVC) at Week 16
FVC (measured by handheld spirometer) is the volume of air that can be forcibly and completely blown out after full inspiration, measured in liters.
Time frame: Baseline, Week 16
Change From Baseline in Forced Expiratory Flow at 25-75% of Pulmonary Volume (FEF25%-75%) at Week 16
The FEF25%-75% (measured by handheld spirometer) is the forced expiratory flow from 25% to 75% of FVC
Time frame: Baseline, Week 16
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 16
FeNO was performed prior to the on-site spirometry.
Time frame: Baseline, Week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered treatment emergent (TEAEs) if onset occurred on or after the first dose date. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. AEs include clinically significant changes from baseline in any one of the following categories: clinical laboratory test results, vital signs, ECG findings.
Time frame: From randomization (Week 0) until Week 24