A randomized, double-blind, placebo-controlled clinical endpoint bioequivalence 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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sandoz Private Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2025-09-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sandoz Private Limited

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Bioequivalence

To demonstrate the therapeutic equivalence of a generic fluticasone furoate and vilanterol inhalation powder 100 mcg/25 mcg (Sandoz) and BREO ELLIPTA (fluticasone furoate and vilanterol inhalation powder) 100 mcg/25 (GlaxoSmithKline) mcg in adult participants with asthma

To demonstrate the superiority of fluticasone furoate and vilanterol inhalation powder 100 mcg/25 mcg (Sandoz) and BREO ELLIPTA (fluticasone furoate and vilanterol inhalation powder) 100 mcg/25 (GlaxoSmithKline) over placebo in adult participants with asthma.

Secondary objectives 1

1. To assess the safety and tolerability of fluticasone furoate and vilanterol inhalation powder 100 mcg/25 mcg (Sandoz) and BREO ELLIPTA (fluticasone furoate and vilanterol inhalation powder) 100 mcg/25 (GlaxoSmithKline) in adult participants with asthma

Conditions and MedDRA coding

Asthma

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. 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.
2. Participants who can demonstrate the correct use of inhaler device (during the Run-in period and at Randomization visit).
3. Participants are eligible to participate in this study if they are: a) Of nonchildbearing potential. b) Of childbearing potential, and if they agree to use a highly effective form of contraception as per the contraceptive guidance consistently during the study, starting at Screening and until the EOS. These participants must have a negative pregnancy test at Screening and Randomization visit. c) Participants who produce viable sperm and have a partner of childbearing potential, and if they agree to use an adequate method of contraception as per the contraceptive guidance 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.
4. Participants should not receive treatment for their asthma exacerbation with any prohibited medications.
5. Participants must be 18 to 75 years old (inclusive) at Screening (signing the ICF).
6. Diagnosis of asthma, as defined by the National Asthma Education and Prevention Program, at least 12 weeks prior to Screening.
7. Participants who are stable on their chronic asthma treatment regimen for at least 4 weeks prior to Screening.
8. Pre-bronchodilator FEV1 of >40% and <85% of predicted value, at screening. Note: This test may be repeated once on a different day, within one week of the Screening Visit, due to inadequate treatment withholding, suboptimal technique, or technical failure.
9. Participants with FEV1 reversibility of ≥12% and ≥200 mL within 30 minutes following 360 mcg of albuterol inhalation (via pressurized metered dose inhaler [pMDI]) or equivalent at Screening
10. Participants who are currently non-smoking and have not used tobacco products (ie, cigarettes, cigars, vaping products, or pipe tobacco) or smoked marijuana products, within the past year. Note: Ex-smokers with ≤10 pack-years (i.e, one pack per day for 10 years) of historical use are allowed.
11. 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. Note: Participants must also be able to withhold all inhaled SABA (rescue medication) for at least 6 hours prior to spirometry assessments on study visits.
12. Participants must be able to discontinue their asthma medications during the Run-in period, and for the remainder of the study.

Exclusion criteria 19

1. 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.
2. 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.
3. 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.
4. Participants with asthma exacerbations (i.e, 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.
5. 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).
6. Participants with uncontrolled allergic rhinitis within 15 days prior to screening.
7. Viral, bacterial, fungal, or parasitic, acute upper or lower respiratory tract infection (including COVDI-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.
8. Participants with a history of hepatitis B, hepatitis C, or human immunodeficiency virus 1 and 2.
9. Participants with clinically significant screening laboratory and electrocardiogram (ECG) parameters as per the Investigator’s assessment.
10. Participants receiving systemic, oral, parental or depot corticosteroids or anti-IgE therapy withing 12 weeks prior to Screening spirometry or unable to stop receiving these medications during the study.
11. Participants receiving B2-blockers, anti-arrhythmics, anti-depressants, monoamine oxidase inhibitors, cytochrome P450 3A4 inhibitors, or diuretics within 4 weeks prior to the Screening spirometry or unable to stop receiving these medications during the study.
12. Participants receiving monoclonal antibodies that may affect the course of asthma withing 180 days prior to the Screening spirometry or unable to stop receiving these medications during the study.
13. Participants receiving live attenuated vaccines withing two days prior to Screening.
14. Participants who received an investigational drug within 28 days or 5 half-lives (whichever is longer) prior to Screening.
15. Hypersensitivity to any sympathomimetic drug (e.g., albuterol, vilanterol) or to any inhaled, intranasal, or systemic corticosteroid therapy, or to milk proteins, or to excipients in the dry powder inhaler.
16. Participants with significant alcohol or controlled substance abuse in the past 6 months, per the judgement of the Investigator.
17. Participants with any factors (e.g., infirmity, disability, or geographic location) that the Investigators feel would likely limit the participant’s compliance with the study protocol or scheduled clinic visits.
18. Participants who cannot communicate reliably or who are unlikely to co-operate with the requirements of the study, in the opinion of the Investigator.
19. Participants who are pregnant, breastfeeding, or planning to become pregnant during the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. FEV1 AUC0-24h on the first day of the treatment
2. FEV1 measured in the morning prior to the dosing of inhaled medications on the last day of the 4-week treatment period. Note: The primary endpoints will be baseline-adjusted (change from baseline).

Secondary endpoints 1

1. Adverse events (including TEAEs, SAEs, and/or AEs leading to study medication/study discontinuation), vital signs, and physical examination findings.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sandoz Private Limited

Sponsor organisation

Sandoz Private Limited

Address

Building No. 2700 Plot No. 4 Survey Nos. 101 101/2 And 340, Genome Valley Lalgadi Malakpet Village, Shameerpet Mandal Genome Valley Lalgadi Malakpet Village Shameerpet Mandal

City

Hyderabad

Postcode

500101

Country

India

Scientific contact point

Organisation

Sandoz Private Limited

Contact name

Bill Brashier

Public contact point

Organisation

Sandoz Private Limited

Contact name

Bill Brashier

Third parties 6

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications