A Study to Test if TEV-48574 is Effective in Relieving Asthma
- Conditions
- Asthma
- Interventions
- Drug: PlaceboDrug: TEV-48574
- Registration Number
- NCT04545385
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 65
- The participant has a diagnosis of asthma for at least 12 months prior to the initial screening visit.
- The participant is able to perform technically acceptable and repeatable spirometry, including with a hand-held spirometer, after training
- The participant has had at least one documented clinical asthma exacerbation in the 18 months prior to (but not within 30 days of) the initial screening visit.
- The participant is a non-smoker for ≥6 months with lifetime history ≤10 pack-years, with no current ecigarette or marijuana use.
NOTE- Additional criteria apply, please contact the investigator for more information
- The participant has any concomitant conditions or treatments that could interfere with study conduct.
- The participant is currently pregnant or lactating or is planning to become pregnant during the study.
- The participant has received any live or attenuated vaccine within 15 days of the initial screening visit.
NOTE- Additional criteria apply, please contact the investigator for more information
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo matching to TEV-48574 SC every 2 weeks for a total of 8 doses. TEV-48574 TEV-48574 Participants will receive the investigational medicinal product (IMP) loading doses on the day of randomization and the subsequent corresponding IMP maintenance doses every 2 weeks for a total of 8 doses (1 loading dose and 7 maintenance doses).
- Primary Outcome Measures
Name Time Method Number of Participants Who Experienced Loss of Asthma Control (LoAC) During the Treatment Period From randomization (Week 0) until Week 16 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Daily Average Use of Short-acting Beta-agonist (SABA) Quick Relief Medication at Week 16 Baseline, Week 16 Number of inhalations/puffs of SABA/quick relief inhaler used was recorded in the e-diary daily.
Time From Randomization to First CAE During the Treatment Period for Participants With CAE From randomization (Week 0) until Week 16 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 From Randomization to LoAC During the Treatment Period From randomization (Week 0) until Week 16 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.
Change From Baseline in Asthma Control Questionnaire 6-Question Version (ACQ-6) Score at Week 16 Baseline, 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.
Change From Baseline in Percent Predicted Forced Expiratory Volume in the First Second (FEV1) at Week 16 Baseline, 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%.
Number of Participants Who Had a Clinical Asthma Exacerbation (CAE) During the Treatment Period From randomization (Week 0) until Week 16 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).Change From Baseline in Forced Vital Capacity (FVC) at Week 16 Baseline, 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.
Change From Baseline in Number of Nighttime Awakenings Due to Asthma at Week 16 Baseline, Week 16 Participants recorded the number of nighttime awakenings due to asthma in the e-diary daily, in the morning.
Percent Change in ICS Dose During the Treatment Period From randomization (Week 0) until Week 16 The ICS dose was not collected in the participant diary as planned.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From randomization (Week 0) until Week 24 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.
Change From Baseline in Forced Expiratory Flow at 25-75% of Pulmonary Volume (FEF25%-75%) at Week 16 Baseline, Week 16 The FEF25%-75% (measured by handheld spirometer) is the forced expiratory flow from 25% to 75% of FVC
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 16 Baseline, Week 16 FeNO was performed prior to the on-site spirometry.
Trial Locations
- Locations (97)
Teva Investigational Site 14896
🇺🇸Los Angeles, California, United States
Teva Investigational Site 14918
🇺🇸Los Angeles, California, United States
Teva Investigational Site 14921
🇺🇸Houston, Texas, United States
Teva Investigational Site 59164
🇧🇬Ruse, Bulgaria
Teva Investigational Site 14925
🇺🇸Allen, Texas, United States
Teva Investigational Site 14877
🇺🇸North Dartmouth, Massachusetts, United States
Teva Investigational Site 14922
🇺🇸Saint Louis, Missouri, United States
Teva Investigational Site 15227
🇺🇸Skillman, New Jersey, United States
Teva Investigational Site 15221
🇺🇸Charlotte, North Carolina, United States
Teva Investigational Site 54203
🇨🇿Strakonice, Czechia
Teva Investigational Site 59166
🇧🇬Montana, Bulgaria
Teva Investigational Site 54197
🇨🇿Brandys nad Labem, Czechia
Teva Investigational Site 54195
🇨🇿Prague 8, Czechia
Teva Investigational Site 54193
🇨🇿Miroslav, Czechia
Teva Investigational Site 32741
🇩🇪Frankfurt am Main, Germany
Teva Investigational Site 54196
🇨🇿Teplice, Czechia
Teva Investigational Site 32759
🇩🇪Frankfurt/Main, Germany
Teva Investigational Site 53457
🇵🇱Krakow, Poland
Teva Investigational Site 53455
🇵🇱Lodz, Poland
Teva Investigational Site 32757
🇩🇪Leipzig, Germany
Teva Investigational Site 14887
🇺🇸Wilmington, North Carolina, United States
Teva Investigational Site 15226
🇺🇸Monroe, North Carolina, United States
Teva Investigational Site 14888
🇺🇸Edmond, Oklahoma, United States
Teva Investigational Site 14909
🇺🇸Dallas, Texas, United States
Teva Investigational Site 14902
🇺🇸El Paso, Texas, United States
Teva Investigational Site 14919
🇺🇸Fort Worth, Texas, United States
Teva Investigational Site 14920
🇺🇸Spokane, Washington, United States
Teva Investigational Site 14893
🇺🇸Saint Louis, Missouri, United States
Teva Investigational Site 54194
🇨🇿Jindrichuv Hradec, Czechia
Teva Investigational Site 59165
🇧🇬Varna, Bulgaria
Teva Investigational Site 32747
🇩🇪Berlin, Germany
Teva Investigational Site 14905
🇺🇸McKinney, Texas, United States
Teva Investigational Site 14882
🇺🇸Raleigh, North Carolina, United States
Teva Investigational Site 14886
🇺🇸Dublin, Ohio, United States
Teva Investigational Site 14901
🇺🇸Toledo, Ohio, United States
Teva Investigational Site 14923
🇺🇸Philadelphia, Pennsylvania, United States
Teva Investigational Site 14914
🇺🇸Bakersfield, California, United States
Teva Investigational Site 15234
🇺🇸Huntington Beach, 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 14916
🇺🇸Walnut Creek, California, United States
Teva Investigational Site 14891
🇺🇸San Jose, California, United States
Teva Investigational Site 15231
🇺🇸Stockton, California, United States
Teva Investigational Site 14878
🇺🇸Westminster, California, United States
Teva Investigational Site 15223
🇺🇸Cutler Bay, Florida, United States
Teva Investigational Site 14900
🇺🇸Miami, Florida, United States
Teva Investigational Site 14883
🇺🇸Miami, Florida, United States
Teva Investigational Site 14908
🇺🇸Panama City, Florida, United States
Teva Investigational Site 14924
🇺🇸Evansville, Indiana, United States
Teva Investigational Site 14897
🇺🇸Kansas City, Kansas, United States
Teva Investigational Site 15220
🇺🇸Baltimore, Maryland, United States
Teva Investigational Site 32739
🇩🇪Hamburg, Germany
Teva Investigational Site 53483
🇵🇱Poznan, Poland
Teva Investigational Site 53459
🇵🇱Poznan, Poland
Teva Investigational Site 53462
🇵🇱Tarnow, Poland
Teva Investigational Site 14911
🇺🇸Hialeah, Florida, United States
Teva Investigational Site 14895
🇺🇸Colorado Springs, Colorado, United States
Teva Investigational Site 59163
🇧🇬Plovdiv, Bulgaria
Teva Investigational Site 32743
🇩🇪Muenchen, Germany
Teva Investigational Site 53458
🇵🇱Krakaw, Poland
Teva Investigational Site 59159
🇧🇬Kozloduy, Bulgaria
Teva Investigational Site 59167
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59161
🇧🇬Stara Zagora, Bulgaria
Teva Investigational Site 32744
🇩🇪Geesthacht, Germany
Teva Investigational Site 32746
🇩🇪Hannover, Germany
Teva Investigational Site 53486
🇵🇱Sucha Beskidzka, Poland
Teva Investigational Site 53485
🇵🇱Warszawa, Poland
Teva Investigational Site 14915
🇺🇸Little Rock, Arkansas, United States
Teva Investigational Site 14894
🇺🇸Tallahassee, Florida, United States
Teva Investigational Site 59160
🇧🇬Stara Zagora, Bulgaria
Teva Investigational Site 32756
🇩🇪Leipzig, Germany
Teva Investigational Site 53461
🇵🇱Bydgoszcz, Poland
Teva Investigational Site 53460
🇵🇱Wroclaw, Poland
Teva Investigational Site 53456
🇵🇱Wroclaw, Poland
Teva Investigational Site 15225
🇺🇸Hialeah, Florida, United States
Teva Investigational Site 14904
🇺🇸Missoula, Montana, United States
Teva Investigational Site 14903
🇺🇸Lincoln, Nebraska, United States
Teva Investigational Site 15222
🇺🇸Coral Gables, Florida, United States
Teva Investigational Site 59189
🇧🇬Plovdiv, Bulgaria
Teva Investigational Site 59190
🇧🇬Plovdiv, Bulgaria
Teva Investigational Site 59168
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59162
🇧🇬Veliko Tarnovo, Bulgaria
Teva Investigational Site 59192
🇧🇬Vratsa, Bulgaria
Teva Investigational Site 32758
🇩🇪Leipzig, Germany
Teva Investigational Site 32742
🇩🇪Luebeck, Germany
Teva Investigational Site 32745
🇩🇪Rheine, Germany
Teva Investigational Site 14917
🇺🇸Denver, Colorado, United States
Teva Investigational Site 14884
🇺🇸Birmingham, Alabama, United States
Teva Investigational Site 14907
🇺🇸San Diego, California, United States
Teva Investigational Site 14880
🇺🇸Oklahoma City, Oklahoma, United States
Teva Investigational Site 14890
🇺🇸Charleston, South Carolina, United States
Teva Investigational Site 15224
🇺🇸Tampa, Florida, United States
Teva Investigational Site 14889
🇺🇸Cincinnati, Ohio, United States
Teva Investigational Site 15230
🇺🇸Austin, Texas, United States
Teva Investigational Site 14879
🇺🇸San Antonio, Texas, United States
Teva Investigational Site 14912
🇺🇸Bellevue, Nebraska, United States
Teva Investigational Site 14881
🇺🇸Greenfield, Wisconsin, United States