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A Study to Test if TEV-48574 is Effective in Relieving Asthma

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TEV-48574
Placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring T2 low, non-T2 asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Teva Investigational Site 14884
  • Teva Investigational Site 14915
  • Teva Investigational Site 14914
  • Teva Investigational Site 15234
  • Teva Investigational Site 14896
  • Teva Investigational Site 14918
  • Teva Investigational Site 14913
  • Teva Investigational Site 14910
  • Teva Investigational Site 14907
  • Teva Investigational Site 14891
  • Teva Investigational Site 15231
  • Teva Investigational Site 14916
  • Teva Investigational Site 14878
  • Teva Investigational Site 14895
  • Teva Investigational Site 14917
  • Teva Investigational Site 15222
  • Teva Investigational Site 15223
  • Teva Investigational Site 14911
  • Teva Investigational Site 15225
  • Teva Investigational Site 14900
  • Teva Investigational Site 14883
  • Teva Investigational Site 14908
  • Teva Investigational Site 14894
  • Teva Investigational Site 15224
  • Teva Investigational Site 14924
  • Teva Investigational Site 14897
  • Teva Investigational Site 15220
  • Teva Investigational Site 14877
  • Teva Investigational Site 14922
  • Teva Investigational Site 14893
  • Teva Investigational Site 14904
  • Teva Investigational Site 14912
  • Teva Investigational Site 14903
  • Teva Investigational Site 15227
  • Teva Investigational Site 15221
  • Teva Investigational Site 15226
  • Teva Investigational Site 14882
  • Teva Investigational Site 14887
  • Teva Investigational Site 14889
  • Teva Investigational Site 14886
  • Teva Investigational Site 14901
  • Teva Investigational Site 14888
  • Teva Investigational Site 14880
  • Teva Investigational Site 14923
  • Teva Investigational Site 14890
  • Teva Investigational Site 14925
  • Teva Investigational Site 15230
  • Teva Investigational Site 14909
  • Teva Investigational Site 14902
  • Teva Investigational Site 14919
  • Teva Investigational Site 14921
  • Teva Investigational Site 14905
  • Teva Investigational Site 14879
  • Teva Investigational Site 14920
  • Teva Investigational Site 14881
  • Teva Investigational Site 59159
  • Teva Investigational Site 59166
  • Teva Investigational Site 59163
  • Teva Investigational Site 59189
  • Teva Investigational Site 59190
  • Teva Investigational Site 59164
  • Teva Investigational Site 59168
  • Teva Investigational Site 59167
  • Teva Investigational Site 59160
  • Teva Investigational Site 59161
  • Teva Investigational Site 59165
  • Teva Investigational Site 59162
  • Teva Investigational Site 59192
  • Teva Investigational Site 54197
  • Teva Investigational Site 54194
  • Teva Investigational Site 54193
  • Teva Investigational Site 54195
  • Teva Investigational Site 54203
  • Teva Investigational Site 54196
  • Teva Investigational Site 32747
  • Teva Investigational Site 32741
  • Teva Investigational Site 32759
  • Teva Investigational Site 32744
  • Teva Investigational Site 32739
  • Teva Investigational Site 32746
  • Teva Investigational Site 32757
  • Teva Investigational Site 32758
  • Teva Investigational Site 32756
  • Teva Investigational Site 32742
  • Teva Investigational Site 32743
  • Teva Investigational Site 32745
  • Teva Investigational Site 53461
  • Teva Investigational Site 53458
  • Teva Investigational Site 53457
  • Teva Investigational Site 53455
  • Teva Investigational Site 53483
  • Teva Investigational Site 53459
  • Teva Investigational Site 53486
  • Teva Investigational Site 53462
  • Teva Investigational Site 53485
  • Teva Investigational Site 53460
  • Teva Investigational Site 53456

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TEV-48574

Placebo

Arm Description

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).

Participants will receive placebo matching to TEV-48574 SC every 2 weeks for a total of 8 doses.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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%.
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.
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 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).
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.
Percent Change in ICS Dose During the Treatment Period
The ICS dose was not collected in the participant diary as planned.
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.
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
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 16
FeNO was performed prior to the on-site spirometry.
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.

Full Information

First Posted
August 24, 2020
Last Updated
March 10, 2023
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04545385
Brief Title
A Study to Test if TEV-48574 is Effective in Relieving Asthma
Official Title
A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Evaluate the Efficacy and Safety of TEV-48574 in Adults With T2-low/Non-T2 Severe Uncontrolled Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Met pre-specified criteria for futility at interim analysis
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
January 17, 2022 (Actual)
Study Completion Date
January 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
T2 low, non-T2 asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEV-48574
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matching to TEV-48574 SC every 2 weeks for a total of 8 doses.
Intervention Type
Drug
Intervention Name(s)
TEV-48574
Intervention Description
subcutaneous infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced Loss of Asthma Control (LoAC) During the Treatment Period
Description
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
Secondary Outcome Measure Information:
Title
Time From Randomization to LoAC During the Treatment Period
Description
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
Title
Change From Baseline in Asthma Control Questionnaire 6-Question Version (ACQ-6) Score at Week 16
Description
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
Title
Change From Baseline in Percent Predicted Forced Expiratory Volume in the First Second (FEV1) at Week 16
Description
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
Title
Change From Baseline in Daily Average Use of Short-acting Beta-agonist (SABA) Quick Relief Medication at Week 16
Description
Number of inhalations/puffs of SABA/quick relief inhaler used was recorded in the e-diary daily.
Time Frame
Baseline, Week 16
Title
Number of Participants Who Had a Clinical Asthma Exacerbation (CAE) During the Treatment Period
Description
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
Title
Time From Randomization to First CAE During the Treatment Period for Participants With CAE
Description
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
Title
Change From Baseline in Number of Nighttime Awakenings Due to Asthma at Week 16
Description
Participants recorded the number of nighttime awakenings due to asthma in the e-diary daily, in the morning.
Time Frame
Baseline, Week 16
Title
Percent Change in ICS Dose During the Treatment Period
Description
The ICS dose was not collected in the participant diary as planned.
Time Frame
From randomization (Week 0) until Week 16
Title
Change From Baseline in Forced Vital Capacity (FVC) at Week 16
Description
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
Title
Change From Baseline in Forced Expiratory Flow at 25-75% of Pulmonary Volume (FEF25%-75%) at Week 16
Description
The FEF25%-75% (measured by handheld spirometer) is the forced expiratory flow from 25% to 75% of FVC
Time Frame
Baseline, Week 16
Title
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 16
Description
FeNO was performed prior to the on-site spirometry.
Time Frame
Baseline, Week 16
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 14884
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Teva Investigational Site 14915
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Teva Investigational Site 14914
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Teva Investigational Site 15234
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Teva Investigational Site 14896
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Teva Investigational Site 14918
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Teva Investigational Site 14913
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Teva Investigational Site 14910
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274-7604
Country
United States
Facility Name
Teva Investigational Site 14907
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Teva Investigational Site 14891
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Teva Investigational Site 15231
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Teva Investigational Site 14916
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Teva Investigational Site 14878
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Teva Investigational Site 14895
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Teva Investigational Site 14917
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Teva Investigational Site 15222
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Teva Investigational Site 15223
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Facility Name
Teva Investigational Site 14911
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Teva Investigational Site 15225
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Teva Investigational Site 14900
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Teva Investigational Site 14883
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Teva Investigational Site 14908
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Teva Investigational Site 14894
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308-4355
Country
United States
Facility Name
Teva Investigational Site 15224
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Teva Investigational Site 14924
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Teva Investigational Site 14897
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Teva Investigational Site 15220
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Teva Investigational Site 14877
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747-3322
Country
United States
Facility Name
Teva Investigational Site 14922
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Teva Investigational Site 14893
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Teva Investigational Site 14904
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Teva Investigational Site 14912
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123-4303
Country
United States
Facility Name
Teva Investigational Site 14903
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505-2343
Country
United States
Facility Name
Teva Investigational Site 15227
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Teva Investigational Site 15221
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Teva Investigational Site 15226
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Teva Investigational Site 14882
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Teva Investigational Site 14887
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Teva Investigational Site 14889
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Teva Investigational Site 14886
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Teva Investigational Site 14901
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Teva Investigational Site 14888
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Teva Investigational Site 14880
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112-4432
Country
United States
Facility Name
Teva Investigational Site 14923
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Teva Investigational Site 14890
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Teva Investigational Site 14925
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Facility Name
Teva Investigational Site 15230
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Teva Investigational Site 14909
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Teva Investigational Site 14902
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903-3508
Country
United States
Facility Name
Teva Investigational Site 14919
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76244
Country
United States
Facility Name
Teva Investigational Site 14921
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Teva Investigational Site 14905
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Teva Investigational Site 14879
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Teva Investigational Site 14920
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Teva Investigational Site 14881
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Facility Name
Teva Investigational Site 59159
City
Kozloduy
ZIP/Postal Code
999999
Country
Bulgaria
Facility Name
Teva Investigational Site 59166
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
Teva Investigational Site 59163
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Teva Investigational Site 59189
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Teva Investigational Site 59190
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Teva Investigational Site 59164
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Teva Investigational Site 59168
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
Teva Investigational Site 59167
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Teva Investigational Site 59160
City
Stara Zagora
ZIP/Postal Code
6001
Country
Bulgaria
Facility Name
Teva Investigational Site 59161
City
Stara Zagora
ZIP/Postal Code
999999
Country
Bulgaria
Facility Name
Teva Investigational Site 59165
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Facility Name
Teva Investigational Site 59162
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Teva Investigational Site 59192
City
Vratsa
ZIP/Postal Code
3001
Country
Bulgaria
Facility Name
Teva Investigational Site 54197
City
Brandys nad Labem
ZIP/Postal Code
25001
Country
Czechia
Facility Name
Teva Investigational Site 54194
City
Jindrichuv Hradec
ZIP/Postal Code
999999
Country
Czechia
Facility Name
Teva Investigational Site 54193
City
Miroslav
ZIP/Postal Code
671 721
Country
Czechia
Facility Name
Teva Investigational Site 54195
City
Prague 8
ZIP/Postal Code
182 00
Country
Czechia
Facility Name
Teva Investigational Site 54203
City
Strakonice
ZIP/Postal Code
999999
Country
Czechia
Facility Name
Teva Investigational Site 54196
City
Teplice
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
Teva Investigational Site 32747
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Teva Investigational Site 32741
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
Teva Investigational Site 32759
City
Frankfurt/Main
ZIP/Postal Code
60389
Country
Germany
Facility Name
Teva Investigational Site 32744
City
Geesthacht
ZIP/Postal Code
21502
Country
Germany
Facility Name
Teva Investigational Site 32739
City
Hamburg
ZIP/Postal Code
22299
Country
Germany
Facility Name
Teva Investigational Site 32746
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Teva Investigational Site 32757
City
Leipzig
ZIP/Postal Code
04537
Country
Germany
Facility Name
Teva Investigational Site 32758
City
Leipzig
ZIP/Postal Code
4157
Country
Germany
Facility Name
Teva Investigational Site 32756
City
Leipzig
ZIP/Postal Code
?04275
Country
Germany
Facility Name
Teva Investigational Site 32742
City
Luebeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Teva Investigational Site 32743
City
Muenchen
ZIP/Postal Code
81241
Country
Germany
Facility Name
Teva Investigational Site 32745
City
Rheine
ZIP/Postal Code
48431
Country
Germany
Facility Name
Teva Investigational Site 53461
City
Bydgoszcz
ZIP/Postal Code
85-231
Country
Poland
Facility Name
Teva Investigational Site 53458
City
Krakaw
ZIP/Postal Code
31-033
Country
Poland
Facility Name
Teva Investigational Site 53457
City
Krakow
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Teva Investigational Site 53455
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Teva Investigational Site 53483
City
Poznan
ZIP/Postal Code
60 - 823
Country
Poland
Facility Name
Teva Investigational Site 53459
City
Poznan
ZIP/Postal Code
60-214
Country
Poland
Facility Name
Teva Investigational Site 53486
City
Sucha Beskidzka
ZIP/Postal Code
34200
Country
Poland
Facility Name
Teva Investigational Site 53462
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Teva Investigational Site 53485
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Teva Investigational Site 53460
City
Wroclaw
ZIP/Postal Code
53-201
Country
Poland
Facility Name
Teva Investigational Site 53456
City
Wroclaw
ZIP/Postal Code
53-301
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.)

Learn more about this trial

A Study to Test if TEV-48574 is Effective in Relieving Asthma

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