Back to resultsA 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS) (VATHOS)
Primary Purpose
Asthma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BFF MDI 320/9.6 μg
BFF MDI 160/9.6 μg
BD MDI 320 μg
Open-label Symbicort TBH 320/9 μg
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- 12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
- Participants who have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1, according to GINA guidelines [GINA 2020]. Healthcare records for 1 year prior to Visit 1 must be provided for adolescent participants (12 to < 18 years of age) to ensure consistent evaluation and follow-up of treatment in those participants.
- Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with the ICS doses, for at least 8 weeks prior to Visit 1.
- ACQ-7 total score ≥ 1.5 at Visits 1 and 4.
- Pre-bronchodilator/pre-dose FEV1 <90% predicted normal value at Visits 1, 2 and 3, and a pre-dose FEV1 of 50% to 90% at Visit 4 (pre-randomization).
- Reversibility to albuterol, defined as a post-albuterol increase in FEV1 of ≥ 12% and ≥ 200 mL for participants ≥ 18 years of age OR a post-albuterol increase of FEV1 of ≥ 12% for participants 12 to < 18 years of age, either in the 12 months prior to Visit 1 or at Visit 2 or Visit 3.
- A pre-bronchodilator/pre-dose FEV1 at Visits 2, 3, and 4 that have not changed 20% or more (increase or decrease) from the pre-bronchodilator/pre-dose FEV1 recorded at the previous visit.
- Demonstrate acceptable MDI administration technique.
- eDiary compliance ≥ 70% during screening, defined as completing the daily eDiary and answering "Yes" to taking 2 puffs of run-in BD MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization.
Exclusion Criteria:
- Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s).
- Any respiratory infection or asthma exacerbation treated with systemic corticosteroids and/or additional ICS treatment in the 8 weeks prior to Visit 1 and throughout the Screening Period.
- Hospitalization for asthma within 8 weeks of Visit 1.
- Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary (eg, active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, and COPD). Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis.
- Known history of drug or alcohol abuse within 12 months of Visit 1.
- Use of a nebulizer or a home nebulizer for receiving asthma medications.
- Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months prior to Visit 1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).
- Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.
- For women only - currently pregnant (confirmed with positive highly sensitive urine pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
BFF MDI 320/9.6 μg
BFF MDI 160/9.6 μg
BD MDI 320 μg
Open-label Symbicort TBH 320/9 μg
Arm Description
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
Budesonide MDI (BD MDI), 320 μg
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
Outcomes
Primary Outcome Measures
United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24
United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24
Secondary Outcome Measures
US (Key secondary): Change from baseline in morning pre-dose trough FEV1 at Week 24
US (Key secondary): Change from baseline in morning pre-dose trough FEV1 at Week 24
Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 24 Weeks
Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 24 Weeks
Percentage of responders in ACQ-7 (≥ 0.5 decrease equals response) at Week 24
Percentage of responders in ACQ-7 (≥ 0.5 decrease equals response) at Week 24
Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) at Week 24
Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) at Week 24
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) (≥ 0.5 increase equals response) at Week 24
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) (≥ 0.5 increase equals response) at Week 24
Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1
Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05202262
Brief Title
A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS)
Acronym
VATHOS
Official Title
A Randomized, Double-Blind, Parallel Group, Multicenter 24 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler and Open-Label Symbicort® Turbuhaler® in Participants With Inadequately Controlled Asthma (VATHOS).
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a 24 week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler in adults and adolescents with inadequately controlled asthma.
Detailed Description
This is a Phase III randomized, double-blind, active comparison, parallel group, multicenter study comparing BFF MDI 320/9.6 μg to BD MDI 320 µg and open-label Symbicort TBH 320/9 μg in adult and adolescent participants who have asthma which remains inadequately controlled (ACQ-7 total score ≥ 1.5) despite treatment with medium dose ICS or ICS/LABA. Budesonide and Formoterol Fumarate MDI 160/9.6 μg is included in this study to evaluate dose response by comparing to BFF MDI 320/9.6 μg. All doses represent the sum of 2 actuations. All study interventions will be administered BID for 24 weeks.
This study will be conducted at approximately 125 sites worldwide and will randomize approximately 630 adult and adolescent participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Open Label for Symbicort TBH
Allocation
Randomized
Enrollment
630 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BFF MDI 320/9.6 μg
Arm Type
Experimental
Arm Description
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
Arm Title
BFF MDI 160/9.6 μg
Arm Type
Experimental
Arm Description
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
Arm Title
BD MDI 320 μg
Arm Type
Experimental
Arm Description
Budesonide MDI (BD MDI), 320 μg
Arm Title
Open-label Symbicort TBH 320/9 μg
Arm Type
Active Comparator
Arm Description
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
Intervention Type
Drug
Intervention Name(s)
BFF MDI 320/9.6 μg
Other Intervention Name(s)
BFF
Intervention Description
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
Intervention Type
Drug
Intervention Name(s)
BFF MDI 160/9.6 μg
Other Intervention Name(s)
BFF
Intervention Description
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
Intervention Type
Drug
Intervention Name(s)
BD MDI 320 μg
Other Intervention Name(s)
BD
Intervention Description
Budesonide MDI (BD MDI), 320 μg
Intervention Type
Drug
Intervention Name(s)
Open-label Symbicort TBH 320/9 μg
Other Intervention Name(s)
Symbicort TBH
Intervention Description
Open-label Symbicort Turbuhaler 320/9 μg
Primary Outcome Measure Information:
Title
United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24
Description
United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24
Time Frame
at week 24
Secondary Outcome Measure Information:
Title
US (Key secondary): Change from baseline in morning pre-dose trough FEV1 at Week 24
Description
US (Key secondary): Change from baseline in morning pre-dose trough FEV1 at Week 24
Time Frame
at week 24
Title
Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 24 Weeks
Description
Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 24 Weeks
Time Frame
over 24 weeks
Title
Percentage of responders in ACQ-7 (≥ 0.5 decrease equals response) at Week 24
Description
Percentage of responders in ACQ-7 (≥ 0.5 decrease equals response) at Week 24
Time Frame
at week 24
Title
Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) at Week 24
Description
Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) at Week 24
Time Frame
at Week 24
Title
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) (≥ 0.5 increase equals response) at Week 24
Description
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) (≥ 0.5 increase equals response) at Week 24
Time Frame
at Week 24
Title
Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1
Description
Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
Participants who have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1, according to GINA guidelines [GINA 2020]. Healthcare records for 1 year prior to Visit 1 must be provided for adolescent participants (12 to < 18 years of age) to ensure consistent evaluation and follow-up of treatment in those participants.
Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with the ICS doses, for at least 8 weeks prior to Visit 1.
ACQ-7 total score ≥ 1.5 at Visits 1 and 4.
Pre-bronchodilator/pre-dose FEV1 <90% predicted normal value at Visits 1, 2 and 3, and a pre-dose FEV1 of 50% to 90% at Visit 4 (pre-randomization).
Reversibility to albuterol, defined as a post-albuterol increase in FEV1 of ≥ 12% and ≥ 200 mL for participants ≥ 18 years of age OR a post-albuterol increase of FEV1 of ≥ 12% for participants 12 to < 18 years of age, either in the 12 months prior to Visit 1 or at Visit 2 or Visit 3.
A pre-bronchodilator/pre-dose FEV1 at Visits 2, 3, and 4 that have not changed 20% or more (increase or decrease) from the pre-bronchodilator/pre-dose FEV1 recorded at the previous visit.
Demonstrate acceptable MDI administration technique.
eDiary compliance ≥ 70% during screening, defined as completing the daily eDiary and answering "Yes" to taking 2 puffs of run-in BD MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization.
Exclusion Criteria:
Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s).
Any respiratory infection or asthma exacerbation treated with systemic corticosteroids and/or additional ICS treatment in the 8 weeks prior to Visit 1 and throughout the Screening Period.
Hospitalization for asthma within 8 weeks of Visit 1.
Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary (eg, active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, and COPD). Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis.
Known history of drug or alcohol abuse within 12 months of Visit 1.
Use of a nebulizer or a home nebulizer for receiving asthma medications.
Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months prior to Visit 1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).
Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.
For women only - currently pregnant (confirmed with positive highly sensitive urine pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Saraland
State/Province
Alabama
ZIP/Postal Code
36571
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30361
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Individual Site Status
Completed
Facility Name
Research Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28226
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77093
Country
United States
Individual Site Status
Completed
Facility Name
Research Site
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23188
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cheney
State/Province
Washington
ZIP/Postal Code
99004
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 0M3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 7M8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5A 4L8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kamloops
State/Province
British Columbia
ZIP/Postal Code
V2C 5T1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3L 1Z5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 2J5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4N 1B3
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N 3V2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Stouffville
State/Province
Ontario
ZIP/Postal Code
L4A 1H2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 2G1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X-5A6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1L5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1G 3Y8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10119
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13156
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Landsberg
ZIP/Postal Code
86899
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04157
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04207
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04299
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Suspended
Facility Name
Research Site
City
München-Pasing
ZIP/Postal Code
81241
Country
Germany
Individual Site Status
Completed
Facility Name
Research Site
City
Rüdersdorf
ZIP/Postal Code
15562
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Schleswig
ZIP/Postal Code
24837
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Witten
ZIP/Postal Code
58452
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mantova
ZIP/Postal Code
46100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20154
Country
Italy
Individual Site Status
Suspended
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rome
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tradate
ZIP/Postal Code
21049
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
103-0022
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
103-0027
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
103-0028
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-0031
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fuchu-shi
ZIP/Postal Code
183-8561
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fukui-shi
ZIP/Postal Code
910-8526
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
819-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Habikino-shi
ZIP/Postal Code
583-8588
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Himeji-shi
ZIP/Postal Code
672-8064
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kagoshima City
ZIP/Postal Code
890-0053
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Katsushika-ku
ZIP/Postal Code
125-0061
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kodaira-shi
ZIP/Postal Code
187-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kokubunji-shi
ZIP/Postal Code
185-0014
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kusatsu-shi
ZIP/Postal Code
525-8585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kyoto-shi
ZIP/Postal Code
601-8213
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Maebashi-shi
ZIP/Postal Code
371-0811
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mizunami-shi
ZIP/Postal Code
509-6134
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Obihiro-shi
ZIP/Postal Code
080-0013
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
531-0073
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
062-0931
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Setagaya-ku
ZIP/Postal Code
158-0097
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shibuya-ku
ZIP/Postal Code
150-0013
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tanabe-shi
ZIP/Postal Code
646-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toon-shi
ZIP/Postal Code
791-0281
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toshima-ku
ZIP/Postal Code
170-0002
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toshima-ku
ZIP/Postal Code
170-0003
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toshima-ku
ZIP/Postal Code
171-0014
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Utsunomiya-shi
ZIP/Postal Code
329-1193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
223-0059
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
231-8682
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yokohama
ZIP/Postal Code
232-0064
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Alor Setar
ZIP/Postal Code
5460
Country
Malaysia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
George Town
ZIP/Postal Code
10450
Country
Malaysia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kajang
ZIP/Postal Code
43000
Country
Malaysia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kuala Lumpur
ZIP/Postal Code
53000
Country
Malaysia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sarawak Miri
ZIP/Postal Code
98000
Country
Malaysia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Seremban
ZIP/Postal Code
70300
Country
Malaysia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Alcorcón
ZIP/Postal Code
28922
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Alzira
ZIP/Postal Code
46410
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bilbao
ZIP/Postal Code
48002
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Centelles (Barcelona)
ZIP/Postal Code
08540
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Girona
ZIP/Postal Code
17005
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Vigo
ZIP/Postal Code
36201
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS)
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