RespiratoryPhase 3NCT07223294
Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in Participants With Asthma
A Phase 3 study testing Fluticasone furoate and vilanterol inhalation powder and Breo Ellipta in people with Respiratory, run by Sandoz.
Trial summary
This is a randomized, multi-center, multiple-dose, double-blind, placebo-controlled, Parallel group design, clinical endpoint bioequivalence study in adult participants with asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Respiratory
- What is being tested?
- Fluticasone furoate and vilanterol inhalation powder and Breo Ellipta
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 Apr 2026to 21 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent (as described in the protocol), which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
- Participants must be 18 to 75 years old (inclusive) at Screening (signing the ICF).
- Diagnosis of asthma, as defined by the National Asthma Education and Prevention Program, at least 12 weeks prior to Screening.
- Participants who are stable on their chronic asthma treatment regimen for at least 4 weeks prior to Screening.
- Pre-bronchodilator FEV1 of >40% and <85% of predicted value, at Screening.
- Participants with FEV1 reversibility of ≥12% and ≥200 mL within 30 minutes following 360 mcg of albuterol inhalation (via pressurized metered dose inhaler pressurized metered-dose inhaler [pMDI]) or equivalent at Screening.
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- This what you mean: Participants who are currently non-smoking and have not used tobacco smoking or smoked marijuana products, within the past year.
- Participants who are able to replace their current regularly scheduled short-acting β2-agonists (SABAs) with a salbutamol/albuterol inhaler for use only on an 'as-needed' basis for the duration of the study.
- Participants must be able to discontinue their asthma medications during the Run-in period, and for the remainder of the study.
- Participants who can demonstrate the correct use of inhaler device (during the Run-in period and at Randomization visit).
- Participants are eligible to participate in this study if they are:
- Of non-childbearing potential
- Of childbearing potential, and if they agree to use a highly effective form of contraception consistently during the study, starting at Screening and until the end of study (EOS). These participants must have a negative pregnancy test at Screening and Randomization visit.
- Participants who produce viable sperm and have a partner of childbearing potential, and if they agree to use an adequate method of contraception consistently during the study, starting at Screening and until the EOS and also refrain from donating sperm during this period. Participants with a partner or partners who is (are) not of childbearing potential are exempt from these requirements.
Who cannot join
- Participants who have life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within one year prior to Screening or during the Run-in period.
- Participants with significant chronic respiratory disease (COPD, interstitial lung disease, etc) other than asthma which in the opinion of the Investigator may interfere with the study evaluation or optimal participation in the study.
- Participants with evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, cardiac dysrhythmia, significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that in the opinion of the Investigator, would put them at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
- Participants with asthma exacerbations (ie, acute or sub-acute worsening in symptoms and lung function from the participant's usual status) within 6 weeks prior to Screening or during the Run-in period.
- Participants with evidence or history of tuberculosis (additionally confirmed with a chest X-ray done within 6 months prior to Screening for countries with high tuberculosis risk).
- Participants with uncontrolled allergic rhinitis within 15 days prior to Screening.
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- Viral, bacterial, fungal, or parasitic, acute upper or lower respiratory tract infection (including Coronavirus Disease (COVID-19)), or sinus, or middle ear infection within 4 weeks prior to Screening, during the Run-in period, or at the Randomization visit. Note: Rescreening of participants with acute respiratory conditions during the Screening and Run-in period may be allowed in consultation with Medical Monitor (Section 5.4).
- Participants with a history of hepatitis B, hepatitis C, or human immunodeficiency virus 1 and 2.
- Participants with clinically significant screening laboratory and electrocardiogram (ECG) parameters as per Investigator's assessment.
- Participants receiving systemic, oral, parenteral or depot corticosteroids, or anti-immunoglobulin E (IgE) therapy within 12 weeks prior to Screening spirometry or unable to stop receiving these medications during the study.
- Participants receiving β2-blockers, anti-arrhythmics, anti-depressants, monoamine oxidase inhibitors, cytochrome P450 3 subfamily A member 4 (3A4) inhibitors, or diuretics within 4 weeks prior to the Screening spirometry or unable to stop receiving these medications during the study.
- Participants receiving monoclonal antibodies that may affect the course of asthma within 180 days prior to the Screening spirometry or unable to stop receiving these medications during the study.
- Participants receiving live attenuated vaccines within two days prior to Screening.
- Participants who received an investigational drug within 28 days or 5 half-lives (whichever is longer) prior to Screening.
- Hypersensitivity to any sympathomimetic drug (eg, albuterol, vilanterol) or to any inhaled, intranasal, or systemic corticosteroid therapy, or to milk proteins, or to excipients in the dry powder inhaler.
- Participants with significant alcohol or controlled substance abuse in the past 6 months, per the judgment of the Investigator.
- Participants with any factors (eg, infirmity, disability, or geographic location) that the Investigator feel would likely limit the participants' compliance with the study protocol or scheduled clinic visits.
- Participants who cannot communicate reliably or who are unlikely to co-operate with the requirements of the study, in the opinion of the Investigator.
- Participants who are pregnant, breastfeeding, or planning to become pregnant during the study.
About this study
Official title: A Randomized, Multicenter, Multiple-dose, Double-blind, Placebo-controlled, Parallel-group Design, Clinical Endpoint Bioequivalence Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg (Sandoz) and BREO® ELLIPTA® (Fluticasone Furoate and Vilanterol Inhalation Powder) 100 mcg/25 mcg (GlaxoSmithKline) in Adult Participants With Asthma
This is a randomized, multi-center, multiple-dose, double-blind, placebo-controlled, Parallel group design, clinical endpoint bioequivalence study in adult participants with asthma.
The study design includes up to a 2-week Screening period, at least a 2-week Run-in period, a 4-week Treatment period, and a safety follow up call one week later.
Read more
Visit 1: Screening Visit 2: Run-in period: All eligible participants will enter a 2-week Run-in period in which training will be provided to the participants on the use of inhalers and participant diary.
Visit 3: Day 1: Randomization to one of the 3 treatment groups to receive one inhalation of the study medication quaque die (QD), in the morning, for 28 ± 2 days.
Visit 4: Day 28: EOT
Participants will be contacted one week after their last site visit for Safety follow-up via phone call (end of study). Participants will be instructed to refrain from taking their current inhaled asthma medications from the start of the Run-in period until the end of treatment (EOT) visit. They will be provided with a salbutamol/albuterol inhaler (rescue medication) for use on an as-needed basis during the entire study duration until the EOT visit.
- Conditions
- Respiratory
- Being tested
- Fluticasone furoate and vilanterol inhalation powder, Breo Ellipta, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone furoate and vilanterol inhalation powderCombination product
Fluticasone furoate and vilanterol inhalation powder 100 mcg/25 mcg
Breo ElliptaCombination product
Fluticasone furoate and Vilanterol inhalation powder) 100 mcg/25 mcg
PlaceboCombination product
Inhalation powder with lactose
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone furoate and vilanterol inhalation powder | Experimental | Fluticasone furoate and Vilanterol inhalation powder 100 mcg/25 mcg QD for 4 weeks Receives: Combination Product: Fluticasone furoate and vilanterol inhalation powder |
| Breo Ellipta | Active comparator | Fluticasone furoate and Vilanterol inhalation powder 100 mcg/25 mcg QD for 4 weeks Receives: Combination Product: Breo Ellipta |
| Placebo | Placebo comparator | Placebo QD for 4 weeks Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the therapeutic equivalence of test and reference product
Forced Expiratory Volume in 1 Second (FEV1) Are Under Curve (AUC 0-24) on Day 1
Measured: Day 1 (0-24Hrs)
Demonstrate the therapeutic equivalence of test and reference product
trough Forced Expiratory Volume in 1 Second (FEV1 on Day 28)
Measured: Day 28 of treatment
Demonstrate the superiority of test and reference product over placebo
Forced Expiratory Volume in 1 Second (FEV1) Are Under Curve (AUC 0-24) on Day 1
Measured: Day 1 (0-24 hours (Hrs)
Demonstrate the superiority of test and reference product over placebo
trough Forced Expiratory Volume in 1 Second (FEV1 on Day 28)
Measured: Day 28 of treatment
Secondary outcomes (1)
To compare the number and type of Adverse Events of Test, Reference and Placebo
Number of Adverse Events, Serious Adverse Events, Treatment-Emergent Adverse Events (TEAE)
Measured: Screening to week 5 (End of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start21 Apr 2026 (estimated)
- Primary completion21 Apr 2026
- Study completion21 Apr 2026
Why it stopped: In response to evolving regulations, product specific guidance by Health Authorities globally, Sandoz plans to streamline its clinical development programs and has therefore strategically decided to discontinue the SAN 1138 clinical study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RespiratoryStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223294
- Sponsor's protocol ID
- SAN-1138
- Status last verified
- May 2026
- First submitted
- 15 Oct 2025
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Multiple-dose, Double-blind, Placebo-controlled, Parallel-group Design, Clinical Endpoint Bioequivalence Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg (Sandoz) and BREO® ELLIPTA® (Fluticasone Furoate and Vilanterol Inhalation Powder) 100 mcg/25 mcg (GlaxoSmithKline) in Adult Participants With Asthma
- ClinicalTrials.gov ID
- NCT07223294
- Acronym / sponsor ID
- SAN-1138
- Conditions
- Respiratory
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: In response to evolving regulations, product specific guidance by Health Authorities globally, Sandoz plans to streamline its clinical development programs and has therefore strategically decided to discontinue the SAN 1138 clinical study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2026 (estimated)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 31 Oct 2025 (actual)
- Results
- Not posted in the source record
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 randomized, multi-center, multiple-dose, double-blind, placebo-controlled, Parallel group design, clinical endpoint bioequivalence study in adult participants with asthma.
The study design includes up to a 2-week Screening period, at least a 2-week Run-in period, a 4-week Treatment period, and a safety follow up call one week later.
Visit 1: Screening Visit 2: Run-in period: All eligible participants will enter a 2-week Run-in period in which training will be provided to the participants on the use of inhalers and participant diary.
Visit 3: Day 1: Randomization to one of the 3 treatment groups to receive one inhalation of the study medication quaque die (QD), in the morning, for 28 ± 2 days.
Visit 4: Day 28: EOT
Participants will be contacted one week after their last site visit for Safety follow-up via phone call (end of study). Participants will be instructed to refrain from taking their current inhaled asthma medications from the start of the Run-in period until the end of treatment (EOT) visit. They will be provided with a salbutamol/albuterol inhaler (rescue medication) for use on an as-needed basis during the entire study duration until the EOT visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluticasone furoate and vilanterol inhalation powder | Experimental | Combination Product: Fluticasone furoate and vilanterol inhalation powderFluticasone furoate and Vilanterol inhalation powder 100 mcg/25 mcg QD for 4 weeks |
| Breo Ellipta | Active comparator | Combination Product: Breo ElliptaFluticasone furoate and Vilanterol inhalation powder 100 mcg/25 mcg QD for 4 weeks |
| Placebo | Placebo comparator | Combination Product: PlaceboPlacebo QD for 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Capable of giving signed informed consent (as described in the protocol), which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
- Participants must be 18 to 75 years old (inclusive) at Screening (signing the ICF).
- Diagnosis of asthma, as defined by the National Asthma Education and Prevention Program, at least 12 weeks prior to Screening.
- Participants who are stable on their chronic asthma treatment regimen for at least 4 weeks prior to Screening.
- Pre-bronchodilator FEV1 of >40% and <85% of predicted value, at Screening.
Key exclusion criteria (19 listed)
- Participants who have life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within one year prior to Screening or during the Run-in period.
- Participants with significant chronic respiratory disease (COPD, interstitial lung disease, etc) other than asthma which in the opinion of the Investigator may interfere with the study evaluation or optimal participation in the study.
- Participants with evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, cardiac dysrhythmia, significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that in the opinion of the Investigator, would put them at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
- Participants with asthma exacerbations (ie, acute or sub-acute worsening in symptoms and lung function from the participant's usual status) within 6 weeks prior to Screening or during the Run-in period.
- Participants with evidence or history of tuberculosis (additionally confirmed with a chest X-ray done within 6 months prior to Screening for countries with high tuberculosis risk).
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 |
|---|---|---|
| Fluticasone furoate and vilanterol inhalation powderFluticasone furoate and vilanterol inhalation powder 100 mcg/25 mcg | Combination product | Fluticasone furoate and vilanterol inhalation powder |
| Breo ElliptaFluticasone furoate and Vilanterol inhalation powder) 100 mcg/25 mcg | Combination product | Breo Ellipta |
| PlaceboInhalation powder with lactose | Combination product | Placebo |
Primary outcome
Demonstrate the therapeutic equivalence of test and reference product
Time frame: Day 1 (0-24Hrs)
Forced Expiratory Volume in 1 Second (FEV1) Are Under Curve (AUC 0-24) on Day 1
Demonstrate the therapeutic equivalence of test and reference product
Time frame: Day 28 of treatment
trough Forced Expiratory Volume in 1 Second (FEV1 on Day 28)
Demonstrate the superiority of test and reference product over placebo
Time frame: Day 1 (0-24 hours (Hrs)
Forced Expiratory Volume in 1 Second (FEV1) Are Under Curve (AUC 0-24) on Day 1
Demonstrate the superiority of test and reference product over placebo
Time frame: Day 28 of treatment
trough Forced Expiratory Volume in 1 Second (FEV1 on Day 28)
1 secondary outcome
To compare the number and type of Adverse Events of Test, Reference and Placebo
Time frame: Screening to week 5 (End of study)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone furoate and vilanterol inhalation powder and Breo Ellipta in people with Respiratory, run by Sandoz.
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 14 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: withdrawn, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Demonstrate the therapeutic equivalence of test and reference product (time frame: Day 1 (0-24Hrs)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.