AsthmaPhase 3VATHOSNCT05202262

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)

A Phase 3 study testing BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg and BD MDI 320 μg in people with Asthma, run by AstraZeneca at 142 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 to 80 years
Conditions the study is for: Asthma
What is being tested?: BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg and BD MDI 320 μg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 645 participants
Where: 142 sitesin 7 countries
Study dates: 12 Jan 2022to 26 Feb 2025
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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 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.
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 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.

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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.
Asthma stability during run-in based on Investigator discretion using the symptom worsening assessment.
Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.
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.

Who cannot join

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.
Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1.

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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.
Previous or current randomization into studies within the AEROSPHERE program including KALOS, LOGOS, VATHOS, LITHOS, or any glycopyrronium studies (PT001).
Use of a nebulizer or a home nebulizer for receiving asthma medications.
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.
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).
Participants with known hypersensitivity to beta2-agonists, corticosteroids, or any component of the MDI.
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.
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).
Planned hospitalization during the study.
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.
Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
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.

Trial locations and contacts

142 sites in 7 countries.

Country

City, postcode or hospital

142 sites in 7 countries

United States66 sites

Research Site
Atlanta, Georgia, 30361
Research Site
Austin, Texas, 78759
Research Site
Bakersfield, California, 93301
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Beaumont, Texas, 77701
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Bellevue, Nebraska, 68123
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Boerne, Texas, 78006
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Chandler, Arizona, 85224
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Cincinnati, Ohio, 45236
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Columbia, Missouri, 65203
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Columbus, Ohio, 43215
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Cutler Bay, Florida, 33189
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Dallas, Texas, 75231
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DeLand, Florida, 32720
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Denver, Colorado, 80230
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Edmond, Oklahoma, 73034
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El Paso, Texas, 79912
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Farmington Hills, Michigan, 48336
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Forney, Texas, 75126
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Fresno, California, 93720
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Gastonia, North Carolina, 28054
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Henderson, Nevada, 89052
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Houston, Texas, 77093
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Huntington Beach, California, 92647
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Kalispell, Montana, 59901
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Knoxville, Tennessee, 37909
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La Palma, California, 90623
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Lexington, Kentucky, 40509
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Lincoln, California, 95648
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Los Angeles, California, 90017
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Los Angeles, California, 90025
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Los Angeles, California, 90048
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Miami, Florida, 33155
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Miami, Florida, 33173
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Miami, Florida, 33175
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Miami, Florida, 33180
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Milwaukee, Wisconsin, 53228
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Missoula, Montana, 59808
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Monroe, North Carolina, 28112
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Newport Beach, California, 92663
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North Dartmouth, Massachusetts, 02747
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North Las Vegas, Nevada, 89030
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Northridge, California, 91324
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Oklahoma City, Oklahoma, 73120
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Omaha, Nebraska, 68114
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Peoria, Illinois, 61636
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Pittsburgh, Pennsylvania, 15236
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Portland, Oregon, 97202
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Portsmouth, New Hampshire, 03801
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Raleigh, North Carolina, 27607
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Red Oak, Texas, 75154
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Sacramento, California, 95823
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Saint Charles, Missouri, 63301
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San Antonio, Texas, 78229
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San Antonio, Texas, 78258
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San Diego, California, 92120
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San Diego, California, 92123
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San Jose, California, 95117
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Skillman, New Jersey, 08558
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St Louis, Missouri, 63141
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Tampa, Florida, 33607
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Tucson, Arizona, 85745
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Victoria, Texas, 77901
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Waco, Texas, 76712
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Wheat Ridge, Colorado, 80033
Research Site
White Marsh, Maryland, 21162
Research Site
Williamsburg, Virginia, 23188

Other trials in United States

Japan28 sites

Research Site
Chūōku, 103-0022
Research Site
Chūōku, 103-0027
Research Site
Chūōku, 103-0028
Research Site
Chūōku, 104-0031
Research Site
Fukui-shi, 910-8526
Research Site
Fukuoka, 819-8555
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Himeji-shi, 672-8064
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Kagoshima, 890-0053
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Kishiwada-shi, 596-8501
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Kodaira-shi, 187-0024
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Kokubunji-shi, 185-0014
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Kusatsu-shi, 525-8585
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Kyoto, 601-8213
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Kyoto, 612-8555
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Mizunami-shi, 509-6134
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Obihiro-shi, 080-0013
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Osaka, 531-0073
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Sapporo, 062-0931
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Setagaya-ku, 158-0097
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Shibuya-ku, 150-0013
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Toon-shi, 791-0281
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Toshima-ku, 170-0002
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Toshima-ku, 170-0003
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Toshima-ku, 171-0014
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Utsunomiya, 329-1193
Research Site
Yokohama, 223-0059
Research Site
Yokohama, 232-0024
Research Site
Yokohama, 232-0064

Other trials in Japan

Canada16 sites

Research Site
Ajax, Ontario, L1S 2J5
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Burlington, Ontario, L7N 3V2
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Calgary, Alberta, T3B 0M3
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Calgary, Alberta, T3E 7M8
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Edmonton, Alberta, T5A 4L8
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Kamloops, British Columbia, V2C 5T1
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Moncton, New Brunswick, E1G 1A7
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Montreal, Quebec, H2V 2K1
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Québec, Quebec, G1G 3Y8
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Québec, Quebec, G1V 4W2
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Québec, Quebec, G2J 0C4
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Stouffville, Ontario, L4A 1H2
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Toronto, Ontario, M9V 4B4
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Windsor, Ontario, N8X 2G1
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Windsor, Ontario, N8X-5A6
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Winnipeg, Manitoba, R3L 1Z5

Other trials in Canada

Germany15 sites

Research Site
Berlin, 10119
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Berlin, 10787
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Berlin, 10961
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Berlin, 12157
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Berlin, 13156
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Frankfurt am Main, 60596
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Landsberg, 86899
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Leipzig, 04157
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Leipzig, 04207
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Leipzig, 04299
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Magdeburg, 39120
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München-Pasing, 81241
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Schleswig, 24837
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Wiesbaden, 65189
Research Site
Witten, 58452

Other trials in Germany

Spain8 sites

Research Site
Badalona, 08916
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Barcelona, 08017
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Bilbao, 48002
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Granada, 18004
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Granada, 18014
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Madrid, 28041
Research Site
Santiago de Compostela, 15702
Research Site
Vigo, 36201

Other trials in Spain

Italy7 sites

Research Site
Brescia, 25123
Research Site
Mantua, 46100
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Naples, 80131
Research Site
Roma, 00133
Research Site
Roma, 00168
Research Site
Rome, 00165
Research Site
Tradate, 21049

Other trials in Italy

Vietnam2 sites

Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000

Other trials in Vietnam

About this study

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).

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.

Read the 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.

Conditions: Asthma
Being tested: BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg, BD MDI 320 μg, Open-label Symbicort TBH 320/9 μg
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BFF MDI 320/9.6 μgDrug
Also called BFF
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
BFF MDI 160/9.6 μgDrug
Also called BFF
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
BD MDI 320 μgDrug
Also called BD
Budesonide MDI (BD MDI), 320 μg
Open-label Symbicort TBH 320/9 μgDrug
Also called Symbicort TBH
Open-label Symbicort Turbuhaler 320/9 μg

Study groups in NCT05202262
Study group	Role	What they receive
BFF MDI 320/9.6 μg	Experimental	Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg Receives: Drug: BFF MDI 320/9.6 μg
BFF MDI 160/9.6 μg	Experimental	Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg Receives: Drug: BFF MDI 160/9.6 μg
BD MDI 320 μg	Experimental	Budesonide MDI (BD MDI), 320 μg Receives: Drug: BD MDI 320 μg
Open-label Symbicort TBH 320/9 μg	Active comparator	Open-Label Comparator Symbicort Turbuhaler 320/9 μg Receives: Drug: Open-label Symbicort TBH 320/9 μg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0 to 3 Hours (AUC0-3) at Week 24
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24. FEV1 AUC0-3 is calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time to report the result in liters. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Measured: At Week 24

Secondary outcomes (8)

Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
Change from baseline in morning pre-dose trough FEV1 at Week 24. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Measured: At 24 Weeks
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. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Measured: On Day 1
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. Baseline is the average during the last 7 days before randomization. Over 24 weeks is the average from randomization up to week 24. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Measured: Over 24 Weeks
Percentage of Responders in ACQ-7 (≥ 0.5 Decrease Equals Response) at Week 24
Percentage of responders in ACQ-7 at Week 24, where responders are defined as participants with a ≥0.5 decrease in total score from baseline. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Measured: At Week 24
Percentage of Responders in ACQ-5 (≥ 0.5 Decrease Equals Response) at Week 24
Percentage of responders in ACQ-5 at Week 24, where responders are defined as participants with a ≥0.5 decrease in total score from baseline. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Measured: 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) at Week 24, where responders are defined as participants with a ≥0.5 increase in total score from baseline. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Measured: At Week 24
Rate of Severe Asthma Exacerbation (Pooled LITHOS and VATHOS Data) During the Treatment Period (up to 24 Weeks)
As requested by a Health Authority, data from VATHOS and LITHOS (NCT05755906), two studies originally designed to assess lung function, were pooled to analyze the annualized rate of severe asthma exacerbations. This analysis was prespecified, uses data up to 12 weeks for LITHOS and 24 weeks for VATHOS, and was incorporated into the multiple testing procedure. An exacerbation is considered severe if it results in at least one of the following: a course of systemic corticosteroids (SCS) for ≥3 consecutive days to treat symptoms of asthma worsening, an ER or urgent care visit due to asthma requiring treatment with SCS, an in-patient hospitalization due to asthma, or death related to asthma. Treatment policy is implemented to handle all intercurrent events except for initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is used.
Measured: 24 Weeks
Rate of Severe Asthma Exacerbation During the Treatment Period (up to 24 Weeks)
Annualized rate of severe asthma exacerbation during the treatment period (up to 24 Weeks). An asthma exacerbation will be considered severe if it results in at least one of the following: a course of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening, an ER or urgent care visit due to asthma that required treatment with systemic corticosteroids, an in-patient hospitalization due to asthma, or death related to asthma.
Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 202226 Feb 2025

First posted21 Jan 2022
Study start12 Jan 2022
Primary completion26 Feb 2025
Study completion26 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 645 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05202262
Sponsor's protocol ID: D5982C00006
Other IDs: 2024-513568-24-00, 2021-002026-24
Acronym: VATHOS
Status last verified: Nov 2025
First submitted: 10 Jan 2022
Last updated: 28 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Jackson DJ, Wise RA, Papi A, Lugogo N, Chen R, Chami H, Armengol C, Daoud SZ, Naucler E, Bowen K, Megally A, Sobande O, Patel M. Budesonide/formoterol fumarate dihydrate versus budesonide with a novel suspension technology for uncontrolled asthma: phase 3 VATHOS study. ERJ Open Res. 2026 Sep 14;12(5):01817-2025. doi: 10.1183/23120541.01817-2025. eCollection 2026 Sep.
PubMed 42741605

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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).
ClinicalTrials.gov ID: NCT05202262
Acronym / sponsor ID: VATHOS / D5982C00006
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 645 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 12 Jan 2022 (actual)
Primary completion: 26 Feb 2025 (actual)
Study completion: 26 Feb 2025 (actual)
First posted: 21 Jan 2022 (actual)
Results: Posted 28 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 study will be conducted at approximately 125 sites worldwide and will randomize approximately 630 adult and adolescent participants.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
BFF MDI 320/9.6 μg	Experimental	Drug: BFF MDI 320/9.6 μgBudesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
BFF MDI 160/9.6 μg	Experimental	Drug: BFF MDI 160/9.6 μgBudesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
BD MDI 320 μg	Experimental	Drug: BD MDI 320 μgBudesonide MDI (BD MDI), 320 μg
Open-label Symbicort TBH 320/9 μg	Active comparator	Drug: Open-label Symbicort TBH 320/9 μgOpen-Label Comparator Symbicort Turbuhaler 320/9 μg

Who may qualify

Ages: 12 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

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 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.
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).

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BFF MDI 320/9.6 μgAlso: BFFBudesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg	Drug	BFF MDI 320/9.6 μg
BFF MDI 160/9.6 μgAlso: BFFBudesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg	Drug	BFF MDI 160/9.6 μg
BD MDI 320 μgAlso: BDBudesonide MDI (BD MDI), 320 μg	Drug	BD MDI 320 μg
Open-label Symbicort TBH 320/9 μgAlso: Symbicort TBHOpen-label Symbicort Turbuhaler 320/9 μg	Drug	Open-label Symbicort TBH 320/9 μg

Primary outcome

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
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24. FEV1 AUC0-3 is calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time to report the result in liters. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.

8 secondary outcomes

Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
Time frame: At 24 Weeks
Onset of Action on Day 1: Absolute Change in FEV1 at 5 Minutes on Day 1
Time frame: On Day 1
Change From Baseline in the Mean Number of Puffs of Rescue Medication Use (Puffs/Day) Over 24 Weeks
Time frame: Over 24 Weeks
Percentage of Responders in ACQ-7 (≥ 0.5 Decrease Equals Response) at Week 24
Time frame: At Week 24
Percentage of Responders in ACQ-5 (≥ 0.5 Decrease Equals Response) at Week 24
Time frame: 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
Time frame: At Week 24
Rate of Severe Asthma Exacerbation (Pooled LITHOS and VATHOS Data) During the Treatment Period (up to 24 Weeks)
Time frame: 24 Weeks
Rate of Severe Asthma Exacerbation During the Treatment Period (up to 24 Weeks)
Time frame: 24 Weeks

Results and safety

Results posted to the registry on 28 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BFF MDI 160/9.6 g	88	81
BFF MDI 320/9.6 g	163	150
BD MDI 320 g	168	155
Symbicort TBH 320/9 g	162	151

Primary outcome: 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. Least squares mean (Standard Error). Unit: Liter

Measure	BFF MDI 160/9.6 μg n = 83	BFF MDI 320/9.6 μg n = 155	BD MDI 320 μg n = 160	Symbicort TBH 320/9 μg n = 155
Value	0.276 (0.0300)	0.240 (0.0219)	0.067 (0.0216)	0.240 (0.0220)

BFF MDI 320/9.6 μg vs BD MDI 320 μg: Mean Difference (Final Values): 0.173 (95% CI 0.112 to 0.233), p <0.0001, ANCOVA

Population analysed: The Efficacy Set is defined as all participants who are randomized to study intervention and receive any amount of randomized study intervention. Participants are analyzed according to the treatment assigned at randomization, regardless of the actual treatment received. Only subjects with non-missing baseline covariates used in the analysis model are included in the analysis.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BFF MDI 160/9.6 g	3 of 88 (3.4%)	31 of 88 (35.2%)	0 of 88
BFF MDI 320/9.6 g	3 of 163 (1.8%)	45 of 163 (27.6%)	0 of 163
BD MDI 320 g	1 of 168 (0.6%)	40 of 168 (23.8%)	0 of 168
Symbicort TBH 320/9 g	7 of 162 (4.3%)	39 of 162 (24.1%)	0 of 162

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42741605Jackson DJ, Wise RA, Papi A, Lugogo N, Chen R, Chami H, Armengol C, Daoud SZ, Naucler E, Bowen K, Megally A, Sobande O, Patel M. Budesonide/formoterol fumarate dihydrate versus budesonide with a novel suspension technology for uncontrolled asthma: phase 3 VATHOS study. ERJ Open Res. 2026 Sep 14;12(5):01817-2025. doi: 10.1183/23120541.01817-2025. eCollection 2026 Sep.
CSR SynopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

142 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg and BD MDI 320 μg in people with Asthma, run by AstraZeneca at 142 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, Japan, Canada, Germany, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05202262, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.