AsthmaPhase 3LITHOSNCT05755906
A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS)
A Phase 3 study testing BFF MDI 160/9.6 μg BID (320/19.2μg/day) and BD MDI 160 μg BID (320 μg/day) in people with Asthma, run by AstraZeneca at 104 sites in 7 countries.
Trial summary
This is a 12-week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler relative to budesonide 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 160/9.6 μg BID (320/19.2μg/day) and BD MDI 160 μg BID (320 μg/day)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 104 sitesin 7 countries
- Study dates
- 27 Feb 2023to 19 Nov 2024
- 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 of childbearing potential should be using 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 2021]. 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 allowed ICS doses, for at least 8 weeks prior to Visit 1.
- ACQ-7 total score ≥ 1.5 at Visits 1 and 4.
- A 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, if repeat testing is necessary.
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- A pre-bronchodilator/pre-dose FEV1 at Visits 2, 3, and 4 that has 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 defined in Section 8.1.2.8 as a guideline.
- 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. Note: Squamous cell and basal cell carcinomas of the skin are not exclusionary.
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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. Note: Acute use of a nebulizer for an asthma exacerbation during hospitalization is allowed as long as there is no occurrence within 8 weeks of Visit 1.
- 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
104 sites in 7 countries.
104 sites in 7 countries
United States63 sites
Research Site
American Fork, Utah, 84003
Research Site
Annapolis, Maryland, 21401
Research Site
Atlanta, Georgia, 30361
Research Site
Austin, Texas, 78704
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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Bountiful, Utah, 84010
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Chandler, Arizona, 85224
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Columbus, Ohio, 43215
Research Site
Cutler Bay, Florida, 33189
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DeBary, Florida, 32713
Research Site
DeLand, Florida, 32720
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Edmond, Oklahoma, 73034
Research Site
El Paso, Texas, 79912
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Encinitas, California, 92024
Research Site
Farmington Hills, Michigan, 48336
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Fayetteville, North Carolina, 28314
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Forney, Texas, 75126
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Fresno, California, 93720
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Hatboro, Pennsylvania, 19040
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Henderson, Nevada, 89052
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Huntington Beach, California, 92647
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Kalispell, Montana, 59901
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Las Vegas, Nevada, 89102
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Lexington, Kentucky, 40509
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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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Mesa, Arizona, 85213
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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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New Windsor, New York, 12553
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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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Pittsburgh, Pennsylvania, 15236
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Plantation, Florida, 33324
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Portsmouth, New Hampshire, 03801
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Raleigh, North Carolina, 27607
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Rolla, Missouri, 65401
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Sacramento, California, 95823
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San Antonio, Texas, 78229
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San Antonio, Texas, 78258
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San Diego, California, 92123
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San Jose, California, 95117
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Schenectady, New York, 12308
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South Bend, Indiana, 46617
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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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Ventura, California, 93003
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Victoria, Texas, 77901
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Waco, Texas, 76712
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Walnut Creek, California, 94598
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White Marsh, Maryland, 21162
Canada10 sites
Research Site
Ajax, Ontario, L1S 2J5
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Kamloops, British Columbia, V2C 5T1
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Kelowna, British Columbia, V1Y 4N7
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Montreal, Quebec, H3M 1L3
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Penticton, British Columbia, V2A 5L5
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Québec, Quebec, G1G 3Y8
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Québec, Quebec, G1V 4W2
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Toronto, Ontario, M9V 4B4
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Winchester, Ontario, K0C 2K0
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Windsor, Ontario, N8X 2G1
Malaysia9 sites
Research Site
Alor Star, 5460
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George Town, 10450
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Ipoh, 30990
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Kajang, 43000
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Kota Bharu, 15586
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Kuala Lumpur, 59100
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Kuala Terengganu, 20400
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Sarawak Miri, 98000
Research Site
Seremban, 70300
Czechia8 sites
Research Site
Jindřichův Hradec, 377 01
Research Site
Louny, 44 001
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Lovosice, 410 02
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Miroslav, 671 72
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Prague, 148 00
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Prague, 190 00
Research Site
Teplice, 415 01
Research Site
Varnsdorf, 407 47
South Africa5 sites
Research Site
Durban, 4001
Research Site
Durban, 4450
Research Site
Newton, 2113
Research Site
Pretoria, 0186
Research Site
Tygervalley, 7530
South Korea5 sites
Research Site
Daegu, 42415
Research Site
Guri-si, 11923
Research Site
Jeonju, 54907
Research Site
Seoul, 03312
Research Site
Ulsan, 44033
Philippines4 sites
Research Site
Iloilo City, 5000
Research Site
Manila, 1000
Research Site
Manila, 1014
Research Site
Marilao, 3019
About this study
Official title: A Randomized, Double-Blind, Parallel Group, Multicenter 12 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS)
This is a 12-week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler relative to budesonide metered dose inhaler in adults and adolescents with inadequately controlled asthma.
Read the detailed description
This is a Phase III, randomized, double-blind, parallel group, multicenter study comparing Budesonide and Formoterol Fumarate Metered Dose Inhaler (BFF MDI) 160/9.6 μg twice daily (BID) to Budesonide MDI 160 μg (BD MDI), over 12 weeks. The study population will consist of adult and adolescent participants with asthma who remain inadequately controlled, as demonstrated by an Asthma Control Questionnaire (ACQ)-7 total score ≥1.5, despite treatment with low dose inhaled corticosteroid (ICS) or ICS/long-acting beta2-agonist (LABA). This study is to assess the benefits and safety of BFF MDI on lung function and asthma health-related quality of life.
This study will be conducted at approximately 90 sites worldwide and will randomize approximately 340 adult and adolescent participants.
- Conditions
- Asthma
- Being tested
- BFF MDI 160/9.6 μg BID (320/19.2μg/day), BD MDI 160 μg BID (320 μg/day)
- 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 160/9.6 μg BID (320/19.2μg/day)Drug
Also called BFF
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg BID (320/19.2μg/day)
BD MDI 160 μg BID (320 μg/day)Drug
Also called BD
Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day)
| Study group | Role | What they receive |
|---|---|---|
| BFF MDI 160/9.6 μg BID (320/19.2μg/day) | Experimental | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), BDI (320/19.2μg/day) Receives: Drug: BFF MDI 160/9.6 μg BID (320/19.2μg/day) |
| BD MDI 160 μg BID (320 μg/day) | Active comparator | Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day) Receives: Drug: BD MDI 160 μg BID (320 μg/day) |
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 12
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 12. 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 12
Secondary outcomes (8)
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 12
Change from baseline in morning pre-dose trough FEV1 at Week 12. 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 12
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 12 Weeks
Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 12 Weeks. Baseline is the average during the last 7 days before randomization. Over 12 weeks is the average from randomization up to week 12. 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 12 Weeks
Percentage of Responders in ACQ-7 (≥ 0.5 Decrease Equals Response) at Week 12
Percentage of responders in ACQ-7 at Week 12, 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 12
Percentage of Responders in ACQ-5 (≥ 0.5 Decrease Equals Response) at Week 12
Percentage of responders in ACQ-5 at Week 12, 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 12
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 12
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) at Week 12, 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 12
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 LITHOS and VATHOS (NCT05202262), 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 12 Weeks)
Annualized rate of severe asthma exacerbation during the treatment period (up to 12 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: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start27 Feb 2023
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
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
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755906
- Sponsor's protocol ID
- D5982C00005
- Other IDs
- 2021-003334-36
- Acronym
- LITHOS
- Status last verified
- Nov 2025
- First submitted
- 23 Feb 2023
- 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
Papi A, Wise RA, Jackson DJ, 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 LITHOS study. ERJ Open Res. 2026 Sep 14;12(5):01818-2025. doi: 10.1183/23120541.01818-2025. eCollection 2026 Sep.
PubMed 42741620
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 12 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS)
- ClinicalTrials.gov ID
- NCT05755906
- Acronym / sponsor ID
- LITHOS / D5982C00005
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 6 Mar 2023 (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 12-week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler relative to budesonide metered dose inhaler in adults and adolescents with inadequately controlled asthma.
Detailed description
This is a Phase III, randomized, double-blind, parallel group, multicenter study comparing Budesonide and Formoterol Fumarate Metered Dose Inhaler (BFF MDI) 160/9.6 μg twice daily (BID) to Budesonide MDI 160 μg (BD MDI), over 12 weeks. The study population will consist of adult and adolescent participants with asthma who remain inadequately controlled, as demonstrated by an Asthma Control Questionnaire (ACQ)-7 total score ≥1.5, despite treatment with low dose inhaled corticosteroid (ICS) or ICS/long-acting beta2-agonist (LABA). This study is to assess the benefits and safety of BFF MDI on lung function and asthma health-related quality of life.
This study will be conducted at approximately 90 sites worldwide and will randomize approximately 340 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
- 2
| Arm | Type | Receives |
|---|---|---|
| BFF MDI 160/9.6 μg BID (320/19.2μg/day) | Experimental | Drug: BFF MDI 160/9.6 μg BID (320/19.2μg/day)Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), BDI (320/19.2μg/day) |
| BD MDI 160 μg BID (320 μg/day) | Active comparator | Drug: BD MDI 160 μg BID (320 μg/day)Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day) |
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 of childbearing potential should be using 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 2021]. 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 allowed ICS doses, for at least 8 weeks prior to Visit 1.
- ACQ-7 total score ≥ 1.5 at Visits 1 and 4.
- A 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 160/9.6 μg BID (320/19.2μg/day)Also: BFFBudesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg BID (320/19.2μg/day) | Drug | BFF MDI 160/9.6 μg BID (320/19.2μg/day) |
| BD MDI 160 μg BID (320 μg/day)Also: BDBudesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day) | Drug | BD MDI 160 μg BID (320 μg/day) |
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 12
Time frame: At Week 12
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 12. 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 12
Time frame: At Week 12
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 12 Weeks
Time frame: Over 12 Weeks
Percentage of Responders in ACQ-7 (≥ 0.5 Decrease Equals Response) at Week 12
Time frame: At Week 12
Percentage of Responders in ACQ-5 (≥ 0.5 Decrease Equals Response) at Week 12
Time frame: At Week 12
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 12
Time frame: At Week 12
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 12 Weeks)
Time frame: 12 Weeks
Results and safety
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 42741620Papi A, Wise RA, Jackson DJ, 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 LITHOS study. ERJ Open Res. 2026 Sep 14;12(5):01818-2025. doi: 10.1183/23120541.01818-2025. 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.
104 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 160/9.6 μg BID (320/19.2μg/day) and BD MDI 160 μg BID (320 μg/day) in people with Asthma, run by AstraZeneca at 104 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 104 sites in United States, Canada, Malaysia, Czechia, South Africa 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 12 (time frame: At Week 12). 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 NCT05755906, 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.