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) (VATHOS)

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).

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: BFF MDI 320/9.6 μg; Drug: BFF MDI 160/9.6 μg; Drug: BD MDI 320 μg; Drug: Open-label Symbicort TBH 320/9 μg

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.

• Study Type: Interventional
• Enrollment (Estimated): 630
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Canada
  • Quebec, Canada, G1G 3Y8
    • Recruiting
    • Research Site
  • Quebec, Canada, G2J 0C4
    • Recruiting
    • Research Site
  • Quebec, Canada, G1V 4W2
    • Recruiting
    • Research Site
  • Alberta
    • Calgary, Alberta, Canada, T3E 7M8
      • Recruiting
      • Research Site
    • Calgary, Alberta, Canada, T3B 0M3
      • Recruiting
      • Research Site
    • Edmonton, Alberta, Canada, T5A 4L8
      • Recruiting
      • Research Site
  • British Columbia
    • Kamloops, British Columbia, Canada, V2C 5T1
      • Recruiting
      • Research Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3L 1Z5
      • Recruiting
      • Research Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • Recruiting
      • Research Site
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
      • Recruiting
      • Research Site
    • Barrie, Ontario, Canada, L4N 1B3
      • Withdrawn
      • Research Site
    • Burlington, Ontario, Canada, L7N 3V2
      • Recruiting
      • Research Site
    • Stouffville, Ontario, Canada, L4A 1H2
      • Recruiting
      • Research Site
    • Toronto, Ontario, Canada, M9V 4B4
      • Recruiting
      • Research Site
    • Windsor, Ontario, Canada, N8X 2G1
      • Recruiting
      • Research Site
    • Windsor, Ontario, Canada, N8X-5A6
      • Completed
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H3G 1L5
      • Recruiting
      • Research Site
    • Trois-Rivières, Quebec, Canada, G8T 7A1
      • Withdrawn
      • Research Site
• Germany
  • Berlin, Germany, 10119
    • Recruiting
    • Research Site
  • Berlin, Germany, 12157
    • Recruiting
    • Research Site
  • Berlin, Germany, 10969
    • Recruiting
    • Research Site
  • Berlin, Germany, 10787
    • Recruiting
    • Research Site
  • Berlin, Germany, 13156
    • Recruiting
    • Research Site
  • Frankfurt am Main, Germany, 60596
    • Recruiting
    • Research Site
  • Landsberg, Germany, 86899
    • Recruiting
    • Research Site
  • Leipzig, Germany, 04207
    • Recruiting
    • Research Site
  • Leipzig, Germany, 04299
    • Recruiting
    • Research Site
  • Leipzig, Germany, 04157
    • Recruiting
    • Research Site
  • Magdeburg, Germany, 39120
    • Suspended
    • Research Site
  • München-Pasing, Germany, 81241
    • Completed
    • Research Site
  • Rüdersdorf, Germany, 15562
    • Withdrawn
    • Research Site
  • Schleswig, Germany, 24837
    • Recruiting
    • Research Site
  • Wiesbaden, Germany, 65189
    • Recruiting
    • Research Site
  • Witten, Germany, 58452
    • Recruiting
    • Research Site
• Italy
  • Brescia, Italy, 25123
    • Recruiting
    • Research Site
  • Mantova, Italy, 46100
    • Recruiting
    • Research Site
  • Milano, Italy, 20154
    • Withdrawn
    • Research Site
  • Napoli, Italy, 80131
    • Recruiting
    • Research Site
  • Roma, Italy, 00168
    • Recruiting
    • Research Site
  • Roma, Italy, 00133
    • Recruiting
    • Research Site
  • Rome, Italy, 00165
    • Recruiting
    • Research Site
  • Tradate, Italy, 21049
    • Recruiting
    • Research Site
• Japan
  • Chuo-ku, Japan, 103-0022
    • Recruiting
    • Research Site
  • Chuo-ku, Japan, 103-0028
    • Recruiting
    • Research Site
  • Chuo-ku, Japan, 103-0027
    • Recruiting
    • Research Site
  • Chuo-ku, Japan, 104-0031
    • Recruiting
    • Research Site
  • Fuchu-shi, Japan, 183-8561
    • Recruiting
    • Research Site
  • Fukui-shi, Japan, 910-8526
    • Recruiting
    • Research Site
  • Fukuoka-shi, Japan, 819-8555
    • Recruiting
    • Research Site
  • Habikino-shi, Japan, 583-8588
    • Recruiting
    • Research Site
  • Himeji-shi, Japan, 672-8064
    • Recruiting
    • Research Site
  • Kagoshima City, Japan, 890-0053
    • Recruiting
    • Research Site
  • Katsushika-ku, Japan, 125-0061
    • Withdrawn
    • Research Site
  • Kishiwada-shi, Japan, 596-8501
    • Not yet recruiting
    • Research Site
  • Kodaira-shi, Japan, 187-0024
    • Recruiting
    • Research Site
  • Kokubunji-shi, Japan, 185-0014
    • Recruiting
    • Research Site
  • Kusatsu-shi, Japan, 525-8585
    • Recruiting
    • Research Site
  • Kyoto-shi, Japan, 601-8213
    • Recruiting
    • Research Site
  • Kyoto-shi, Japan, 612-8555
    • Not yet recruiting
    • Research Site
  • Maebashi-shi, Japan, 371-0811
    • Recruiting
    • Research Site
  • Mizunami-shi, Japan, 509-6134
    • Recruiting
    • Research Site
  • Obihiro-shi, Japan, 080-0013
    • Recruiting
    • Research Site
  • Osaka-shi, Japan, 531-0073
    • Terminated
    • Research Site
  • Sapporo-shi, Japan, 062-0931
    • Recruiting
    • Research Site
  • Setagaya-ku, Japan, 158-0097
    • Recruiting
    • Research Site
  • Shibuya-ku, Japan, 150-0013
    • Recruiting
    • Research Site
  • Tanabe-shi, Japan, 646-8558
    • Recruiting
    • Research Site
  • Toon-shi, Japan, 791-0281
    • Recruiting
    • Research Site
  • Toshima-ku, Japan, 170-0003
    • Recruiting
    • Research Site
  • Toshima-ku, Japan, 171-0014
    • Recruiting
    • Research Site
  • Toshima-ku, Japan, 170-0002
    • Terminated
    • Research Site
  • Toshima-ku, Japan, 170-0003
    • Terminated
    • Research Site
  • Utsunomiya-shi, Japan, 329-1193
    • Recruiting
    • Research Site
  • Yokohama, Japan, 232-0064
    • Recruiting
    • Research Site
  • Yokohama-shi, Japan, 223-0059
    • Recruiting
    • Research Site
  • Yokohama-shi, Japan, 232-0024
    • Recruiting
    • Research Site
  • Yokohama-shi, Japan, 231-8682
    • Recruiting
    • Research Site
• Malaysia
  • Alor Setar, Malaysia, 5460
    • Withdrawn
    • Research Site
  • George Town, Malaysia, 10450
    • Withdrawn
    • Research Site
  • Kajang, Malaysia, 43000
    • Withdrawn
    • Research Site
  • Kuala Lumpur, Malaysia, 50586
    • Withdrawn
    • Research Site
  • Kuala Lumpur, Malaysia, 59100
    • Withdrawn
    • Research Site
  • Sarawak Miri, Malaysia, 98000
    • Withdrawn
    • Research Site
  • Seremban, Malaysia, 70300
    • Withdrawn
    • Research Site
• Spain
  • A Coruña, Spain, 15006
    • Withdrawn
    • Research Site
  • Alcorcón, Spain, 28922
    • Withdrawn
    • Research Site
  • Alzira, Spain, 46410
    • Withdrawn
    • Research Site
  • Badalona, Spain, 08916
    • Recruiting
    • Research Site
  • Barcelona, Spain, 08023
    • Withdrawn
    • Research Site
  • Barcelona, Spain, 08017
    • Recruiting
    • Research Site
  • Barcelona, Spain, 08540
    • Recruiting
    • Research Site
  • Bilbao, Spain, 48002
    • Recruiting
    • Research Site
  • Burgos, Spain, 09006
    • Withdrawn
    • Research Site
  • Granada, Spain, 18014
    • Recruiting
    • Research Site
  • Granada, Spain, 18004
    • Not yet recruiting
    • Research Site
  • Madrid, Spain, 28041
    • Recruiting
    • Research Site
  • Madrid, Spain, 28007
    • Withdrawn
    • Research Site
  • Oviedo, Spain, 33006
    • Withdrawn
    • Research Site
  • Santiago de Compostela, Spain, 15702
    • Recruiting
    • Research Site
  • Vigo, Spain, 36201
    • Recruiting
    • Research Site
• United States
  • Alabama
    • Saraland, Alabama, United States, 36571
      • Withdrawn
      • Research Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Recruiting
      • Research Site
    • Tucson, Arizona, United States, 85745
      • Recruiting
      • Research Site
  • California
    • Bakersfield, California, United States, 93301
      • Recruiting
      • Research Site
    • Bakersfield, California, United States, 93309
      • Withdrawn
      • Research Site
    • Fresno, California, United States, 93720
      • Terminated
      • Research Site
    • Huntington Beach, California, United States, 92647
      • Withdrawn
      • Research Site
    • Huntington Beach, California, United States, 92647
      • Recruiting
      • Research Site
    • La Palma, California, United States, 90623
      • Recruiting
      • Research Site
    • Lincoln, California, United States, 95648
      • Terminated
      • Research Site
    • Los Angeles, California, United States, 90017
      • Recruiting
      • Research Site
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Research Site
    • Los Angeles, California, United States, 90025
      • Recruiting
      • Research Site
    • Newport Beach, California, United States, 92663
      • Recruiting
      • Research Site
    • Northridge, California, United States, 91324
      • Recruiting
      • Research Site
    • Palm Springs, California, United States, 92262
      • Withdrawn
      • Research Site
    • Sacramento, California, United States, 95823
      • Recruiting
      • Research Site
    • San Diego, California, United States, 92120
      • Recruiting
      • Research Site
    • San Diego, California, United States, 92123
      • Recruiting
      • Research Site
    • San Jose, California, United States, 95117
      • Recruiting
      • Research Site
  • Colorado
    • Denver, Colorado, United States, 80230
      • Completed
      • Research Site
    • Wheat Ridge, Colorado, United States, 80033
      • Recruiting
      • Research Site
  • Florida
    • Cutler Bay, Florida, United States, 33189
      • Recruiting
      • Research Site
    • DeLand, Florida, United States, 32720
      • Recruiting
      • Research Site
    • Hialeah, Florida, United States, 33016
      • Recruiting
      • Research Site
    • Miami, Florida, United States, 33180
      • Recruiting
      • Research Site
    • Miami, Florida, United States, 33175
      • Recruiting
      • Research Site
    • Miami, Florida, United States, 33155
      • Recruiting
      • Research Site
    • Miami, Florida, United States, 33173
      • Recruiting
      • Research Site
    • Tampa, Florida, United States, 33607
      • Recruiting
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30361
      • Recruiting
      • Research Site
  • Illinois
    • Peoria, Illinois, United States, 61636
      • Recruiting
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Terminated
      • Research Site
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Withdrawn
      • Research Site
  • Maryland
    • White Marsh, Maryland, United States, 21162
      • Recruiting
      • Research Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Recruiting
      • Research Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Withdrawn
      • Research Site
    • Farmington Hills, Michigan, United States, 48336
      • Recruiting
      • Research Site
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Recruiting
      • Research Site
    • Saint Charles, Missouri, United States, 63301
      • Recruiting
      • Research Site
    • Saint Louis, Missouri, United States, 63141
      • Recruiting
      • Research Site
  • Montana
    • Kalispell, Montana, United States, 59901
      • Not yet recruiting
      • Research Site
    • Missoula, Montana, United States, 59808
      • Recruiting
      • Research Site
  • Nebraska
    • Bellevue, Nebraska, United States, 68123
      • Recruiting
      • Research Site
    • Omaha, Nebraska, United States, 68114
      • Terminated
      • Research Site
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Recruiting
      • Research Site
    • North Las Vegas, Nevada, United States, 89030
      • Recruiting
      • Research Site
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Recruiting
      • Research Site
  • New Jersey
    • Skillman, New Jersey, United States, 08558
      • Completed
      • Research Site
  • New York
    • New Windsor, New York, United States, 12553
      • Recruiting
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Withdrawn
      • Research Site
    • Charlotte, North Carolina, United States, 28226
      • Withdrawn
      • Research Site
    • Gastonia, North Carolina, United States, 28054
      • Recruiting
      • Research Site
    • Greensboro, North Carolina, United States, 27410
      • Withdrawn
      • Research Site
    • Monroe, North Carolina, United States, 28112
      • Recruiting
      • Research Site
    • Raleigh, North Carolina, United States, 27607
      • Recruiting
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Recruiting
      • Research Site
    • Columbus, Ohio, United States, 43215
      • Recruiting
      • Research Site
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • Recruiting
      • Research Site
    • Oklahoma City, Oklahoma, United States, 73120
      • Recruiting
      • Research Site
  • Oregon
    • Portland, Oregon, United States, 97202
      • Recruiting
      • Research Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15236
      • Recruiting
      • Research Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37919
      • Not yet recruiting
      • Research Site
  • Texas
    • Amarillo, Texas, United States, 79106
      • Recruiting
      • Research Site
    • Andrews, Texas, United States, 79714
      • Not yet recruiting
      • Research Site
    • Austin, Texas, United States, 78759
      • Recruiting
      • Research Site
    • Austin, Texas, United States, 78704
      • Not yet recruiting
      • Research Site
    • Beaumont, Texas, United States, 77701
      • Recruiting
      • Research Site
    • Boerne, Texas, United States, 78006
      • Recruiting
      • Research Site
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Research Site
    • El Paso, Texas, United States, 79903
      • Recruiting
      • Research Site
    • Forney, Texas, United States, 75126
      • Not yet recruiting
      • Research Site
    • Houston, Texas, United States, 77093
      • Terminated
      • Research Site
    • Red Oak, Texas, United States, 75154
      • Terminated
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Research Site
    • San Antonio, Texas, United States, 78258
      • Recruiting
      • Research Site
    • Victoria, Texas, United States, 77901
      • Recruiting
      • Research Site
    • Waco, Texas, United States, 76712
      • Recruiting
      • Research Site
  • Virginia
    • Williamsburg, Virginia, United States, 23188
      • Terminated
      • Research Site
  • Washington
    • Cheney, Washington, United States, 99004
      • Withdrawn
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53228
      • Recruiting
      • Research Site
• Vietnam
  • Hanoi, Vietnam, 100000
    • Recruiting
    • Research Site
  • Ho Chi Minh, Vietnam, 700000
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. 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 one 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.
3. 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.
4. ACQ-7 total score ≥ 1.5 at Visits 1 and 4.
5. 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).
6. 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 in 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.
7. 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.
8. Asthma stability during run-in based on Investigator discretion using the symptom worsening assessment.
9. Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.
10. Demonstrate acceptable MDI administration technique.
11. 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:

1. 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).
2. 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.
3. Hospitalization for asthma within 8 weeks of Visit 1.
4. 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.
5. Known history of drug or alcohol abuse within 12 months of Visit 1.
6. Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1.
7. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in this protocol is prohibited for use during study duration.
8. Previous or current randomization into studies within the AEROSPHERE program including KALOS, LOGOS, VATHOS, LITHOS, or any glycopyrronium studies (PT001).
9. Use of a nebulizer or a home nebulizer for receiving asthma medications.
10. Do not meet the stable dosing period prior to Visit 1 or unable to abstain from protocol-defined prohibited medications during Screening and Treatment Periods.
11. Receipt of COVID-19 vaccine (regardless of vaccine delivery platform, eg, vector, lipid nanoparticle) < 7 days prior to Visit 1 (from last vaccination or booster dose).
12. Participants with known hypersensitivity to beta2-agonists, corticosteroids, or any component of the MDI.
13. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs, or ECG, which in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study.
14. 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).
15. Planned hospitalization during the study.
16. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
17. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.
18. Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
19. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BFF MDI 320/9.6 μg; Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg	Drug: BFF MDI 320/9.6 μg; Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg; Other Names: BFF
Experimental: BFF MDI 160/9.6 μg; Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg	Drug: BFF MDI 160/9.6 μg; Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg; Other Names: BFF
Experimental: BD MDI 320 μg; Budesonide MDI (BD MDI), 320 μg	Drug: BD MDI 320 μg; Budesonide MDI (BD MDI), 320 μg; Other Names: BD
Active Comparator: Open-label Symbicort TBH 320/9 μg; Open-Label Comparator Symbicort Turbuhaler 320/9 μg	Drug: Open-label Symbicort TBH 320/9 μg; Open-label Symbicort Turbuhaler 320/9 μg; Other Names: Symbicort TBH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1
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	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	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	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	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	at Week 24

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Estimated): December 2, 2024
• Study Completion (Estimated): December 2, 2024

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: D5982C00006; 2021-002026-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No