This is a comparative study of fluticasone and vilanterol inhalation powder in adult patients with asthma.
Scientific Title of Study
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.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
SAN-1138 V 1.0 Dated 12 February 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Simon Rodrigues
Designation
Medical Monitor
Affiliation
Sandoz Pvt Ltd
Address
Sandoz Private Limited,
Building no. 2700, Plot no. 4, Survey nos. 101 and 102 and 340, Genome Valley, Lalgadi Malakpet Village, Shameerpet Mandal
Hyderabad TELANGANA 500101 India
Phone
9591798726
Fax
Email
simon_anthony.rodrigues@sandoz.net
Details of Contact Person Public Query
Name
Pramodkumar Ghodke
Designation
Project Manager
Affiliation
Sandoz Pvt Ltd
Address
Sandoz Private Limited,
Building no. 2700, Plot no. 4, Survey nos. 101 and 102 and 340, Genome Valley, Lalgadi Malakpet Village, Shameerpet Mandal
Hyderabad TELANGANA 500101 India
Phone
9511275191
Fax
Email
pramodkumar.ghodke@sandoz.net
Source of Monetary or Material Support
Sandoz Private Limited, Sandoz Development Center, India
Primary Sponsor
Name
Sandoz Private Limited, Sandoz Development Center, India
Address
Sandoz Private Limited, Sandoz Development Center, Building no. 2700, Plot no. 4, Survey nos. 101 and 101, 102 & 340, Genome Valley, Lalgadi Malakpet Village, Shameerpet Mandal, Hyderabad, Telangana 500101, India
Ishwar Heights, PI.No.7, Gut No.6/1, Beside Panjabi Bhavan, Mumbai-Nashik Highway, Padegaon, Aurangabad-431002, Maharashtra, India Aurangabad MAHARASHTRA
9405912791
ishwarhealthcare@gmail.com
Dr Rahul Gupta
Jaipur National University Institute for Medical Science and Research Center
Jaipur-Agra Bypass, near New RTO office, Jaipur-302017,Rajasthan,India Jaipur RAJASTHAN
9257036514
drrahulguptajnj@gmail.com
Dr Piyush Arora
Jawahar Lal Nehru Medical College
Kala Bagh, Ajmer-305001, Rajasthan, India Ajmer RAJASTHAN
9887088122
doctor.piyusharora@gmail.com
Dr Hardik Dineshkumar Shah
Jupiter Hospital & Research Centre
Sun Pharma-Atladra Road, Opp.ICAI Bhavan, Atladara, Vadodara-390012,Gujarat, India Vadodara GUJARAT
90332 90966
drhardikshahnm@gmail.com
Dr Gautam Suresh
K.L.E.S. Dr. Prabhakar Kore Hospital and Medical Research Centre
Nehru Nagar, Belagavi- 590010, Karnataka, India Belgaum KARNATAKA
9964854464
docgautam6787@gmail.com
Dr E Ravindra Reddy
Kamineni Hospitals Private Limited
L. B. Nagar, Hyderabad-500068, Telangana, India Hyderabad TELANGANA
91-9848023703
rvvndrreddy@yahoo.com
Dr Himanshu Shashikant Pophale
Kothrud Hospital
SN no 81/5a/2, Plot No 2, Bhagyachintamani Nagar, Paud Road,Beside NKGSB Bank, Gadiya Estate, Kothrud, Pune-411038, Maharashtra, India Pune MAHARASHTRA
91-7588693308
himanshupophale@yahoo.co.in
Dr Rajkumar Nikalje
Lifepoint Multispeciality Hospital
Sr. No. 145/1, Mumbai-Banglore Highway, Near Hotel Sayaji, Wakad, Pune-411057 Pune MAHARASHTRA
9028560535
nikaljeraj80@gmail.com
Dr Manish Kumar Jain
Maharaja Agrasen Superspeciality Hospital
Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur, Rajasthan, India Jaipur RAJASTHAN
9414414834
doctormanishjain2@gmail.com
Dr Sushama Rikhabchand Dugad
Maratha Vidya Prasarak Samajs, Dr Vasantrao Pawar Medical College, Hospital & Research Centre
BREO ELLIPTA (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 Administration: Oral Inhalation
Intervention
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 Administration: Oral Inhalation
Comparator Agent
Placebo
Inhalation powder with inert excipient, lactose
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
To demonstrate the therapeutic equivalence of test and reference product
-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 Outcome
Outcome
TimePoints
To assess the safety and tolerability
-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)
Target Sample Size
Total Sample Size="1430" Sample Size from India="1144" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a randomized, multicenter, 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 placebo Run-in period, a 4-week Treatment period, and a safety follow up call one week later.
Visit 1 : Screening
Visit 2 : placebo Run-in period : All eligible particiapnts will enter a 2-week placebo Run-in period in which training will be provided to the participants on the use of inhalers (using placebo inhaler device) and participant diary.
Visit 3 : Day 1 : Randomization to one of the 3 treatment groups to receive one inhalation of the study medication 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.