Health Condition 1: J454- Moderate persistent asthma Health Condition 2: J455- Severe persistent asthma
Conditions
Interventions
Intervention1: Fluticasone furoate and vilanterol inhalation powder 100 mcg/25 mcg: Dose Form : Powder
Dose Strength(s):100 mcg/25 mcg
Dosage Level(s) : Once Daily (QD) for 4 weeks
Route of Administr
Sponsors
Sandoz Private Limited, Sandoz Development Center, India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol. 2. Participants must be 18 to 75 years old (inclusive) at Screening. 3. Diagnosis of asthma, as defined by the National Asthma Education and Prevention Program at least 12 weeks prior to Screening. 4. Participants who are stable on their chronic asthma treatment regimen for at least 4 weeks prior to Screening. 5. Pre-bronchodilator FEV1 of more than or equal to 40 percent and less than or equal to 85 percent of predicted value, at Screening. 6. Participants with FEV1 reversibility of more than or equal to 12 percent and more than or equal to 200 mL within 30 minutes following 360 mcg of albuterol inhalation (via pressurized metered dose inhaler) or equivalent at Screening. 7. Participants who are currently non-smoking and have not used tobacco products 8. Participants who are able to replace their current regularly scheduled short-acting agonists (SABAs) with a salbutamol/albuterol inhaler for use only on an as-needed basis for the duration of the study. 9. Participants must be able to discontinue their asthma medications during the Run-in period, and for the remainder of the study 10. Participants who can demonstrate the correct use of inhaler device (during the Run-in period and at Randomization visit). 11. 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. 12. Participants should not receive treatment for their asthma exacerbation with any prohibited medications listed in protocol
Exclusion criteria
Exclusion criteria: 1. Participants who have life-threatening asthma, defined as a history of asthma episode requiring intubation, and or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma-related syncopal episodes, or hospitalizations within one year prior to Screening or during the Run-in period. 2. Participants with significant chronic respiratory disease 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 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 within 6 weeks prior to Screening or during the Run-in period. 5. Participants with evidence or history of tuberculosis. 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 COVID-19), or sinus, or middle ear infection within 4 weeks prior to Screening, during the Run-in period, or at the Randomization visit. 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 parameters as per Investigator s assessment. 10. Participants receiving systemic, oral, parenteral or depot corticosteroids, or anti-IgE therapy within 12 weeks prior to Screening spirometry or unable to stop receiving these medications during the study. 11. Participants Beta2-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 within 180 days prior to the Screening spirometry or unable to stop receiving these medications during the study. 13. Participants receiving live attenuated vaccines within 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 like 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 judgment of the Investigator. 17. Participants with any factors like infirmity, disability, or geographic location that the Investigator feel would likely limit the participant 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the therapeutic equivalence of test and reference productTimepoint: -FEV1 AUC 0-24 h on Day 1 : FEV1 at pre-dose , 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 12 hours, 16 hours, 20 hours, 23 hours and 24 hours post dose. -FEV1 on Day 28, Week 4 at pre-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerabilityTimepoint: -Adverse events from screening to Week 4,Day 28 (EOT) -vital signs and physical examination findings on screening, Day 1(Week 1) and Day 28(Week 4) -Telephonic Follow up on Day 35, Week 5 (EOS) | — |
Countries
India, Poland, United States of America
Contacts
Public ContactPramodkumar Ghodke
Sandoz Pvt Ltd
Outcome results
None listed