CTRI/2025/07/090194 [Registered on: 04/07/2025] Trial Registered Prospectively
Last Modified On:
09/04/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
To Check How Well and Safe a Fixed Mix of Fluticasone Furoate, Umeclidinium, and Vilanterol Works Compared to a Fixed Mix of Indacaterol, Glycopyrronium, and Mometasone Furoate in People with Asthma
Scientific Title of Study
A Randomized, Multi-Centric, Two-Arm, Active-Controlled, Parallel-Group, Open-
Label, Phase III, Comparative Study to Evaluate Efficacy and Safety of Fixed Dose Combination of Fluticasone Furoate, Umeclidinium and Vilanterol Compared to Fixed Dose Combination of Indacaterol, Glycopyrronium and Mometasone Furoate in Patients with Bronchial Asthma
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/24/015, Version No. 2.0, Dated 07.MAR.2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
AVP and Head_India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Dipesh Sonawane
Designation
Deputy General Manager_India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
Dipesh.Sonawane@sunpharma.com
Details of Contact Person Public Query
Name
Digambar Tornale
Designation
Manager 2_India Clinical Research_Medical Affairs & Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
Digambar.Tornale@sunpharma.com
Source of Monetary or Material Support
Sun Pharma Laboratories Limited Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon(E), Mumbai 400 063, Maharashtra, India.
Primary Sponsor
Name
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east, Mumbai 400063, Maharashtra, India.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Sun Pharma Laboratories Limited
Sun Pharma Advanced Research Centre (SPARC), Tandalja, Vadodara-390012, Gujarat, India
OPD No 62 Dr B R Ambedkar Road,
Sadashiv Nagar, Belagavi, Karnataka 590019
Belgaum KARNATAKA
9964451057
Honnavar.santosh@gmail.com
Dr Shafee Mohammed Khan Nazir Khan
Datta Meghe Medical college and Shalinitai Meghe Hospital
Wanadongari Nagpur Maharashtra India 441110 Nagpur MAHARASHTRA
9970243024
Kshafee673@gmail.com
Dr M Swapna
Gandhi Hospital
In Patient Block, 8th floor, department of respiratory medicine, Gandhi Hospital, Musheerabad, Secundrabad, Telangana, India-500003 Hyderabad TELANGANA
9885144447
drmswapna99@gmail.com
Dr Avdhesh Kumar
GSVM Medical
Department of Pulmonology, GSVM Medical College, Swaroop Nagar Kanpur – 208002, U.P. India Kanpur Nagar UTTAR PRADESH
7408441544
Dravikumar1001@gmail.com
Dr Rahul Gupta
Jaipur National University Institute for Medical Sciences and Research Centre
Department of Respiratory Medicine, Jaipur National University Institute for Medical Sciences and Research Centre Agra- Jaipur road Near New RTO Office, Jagatpura, Jaipur, 302017, Rajasthan, India Jaipur RAJASTHAN
7060924809
drrahulguptajnu@gmail.com
Dr Piyush Arora
Jawahar Lal Nehru Medical College
Department of Respiratory Medicine Jawahar Lal Nehru Medical College, Kal Bagh, Ajmer-305001, Rajasthan, India Ajmer RAJASTHAN
9887088122
doctor.piyusharora@gmail.com
Dr Behera Sarat
KIDS Hospital
Department of TB & Chest, KIDS Hospital, Plot No 1120, Dumduma, Bhubaneshwar -751019, Odisha. Khordha ORISSA
9438554039
Saratkubehera1202@gmail.com
Dr Sunil Kumar
King George Hospital Clinical Research Room
Maharanipeta Visakhapatnam - 530002, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH
9849126543
chestdrsunil@gmail.com
Dr Gaurav Ghatawat Bhanwarlal
Lion Tarachand Bapa Hospital and Research Centre
First Floor, Out Patient Department Room No-8, Lion Tarachand Bapa Hospital and Research Centre, C.U Shah Complex Lion Tarachand Bapa Marg, Jian Society, Sion (W) Mumbai Maharashtra -400022 Mumbai MAHARASHTRA
9930628439
Gaurav_ghatawat@yahoo.co.in
Dr Hirennappa B Udnur
Medstar Speciality Hospital
Medstar Speciality Hospital, Pulmonology department, ground floor,641/17/1/3, Kodigehalli Main Road, Sahakar nagar, Bangalore-560092, Karnataka, India Bangalore KARNATAKA
9379246563
Drhirennappa.medstar@gmail.com
Dr Adrita Kar
Mitras Multi-Speciality Hospital
Mitras Multi-Speciality Hospital, 1 Tilak Road, Ward no -12, Hakimpara Siliguri District- Darjeeling West Bengal- 734001 Darjiling WEST BENGAL
9073327359
Mitrahospital.clinical@gmail.com
Dr Jaydeep Deb
Nil ratan Sircar Medical College & Hospital
138 AJC Bose Road Kolkata
700014
Kolkata WEST BENGAL
9830439804
Jaydip.deb@gmail.com
Dr Toke Sahebrao Kondiba
Ojas Multispeciality Hospital
Ojas Multispeciality Hospital, Clinical Research Department, Sr no 203/1 Bhondave Chowk, D.Y patil College Road, Ravet Pune-412101 Pune MAHARASHTRA
9962257627
dr.sahebraotoke@gmail.com
Dr Santosh Kumar
S.N Medical College
Department to Tuberculosis & Chest Diseases, S.N Medical College, Agra, Moti Katra Mantola, Agra- 282003, U.P, India Agra UTTAR PRADESH
9897517869
Skumarde2007@rediffmail.com
Dr Ajit Singh
SMS Medical college and attached Hospitals
Room No 16, First Floor Division of Allergy and Pulmonary Medicine Dhanvantri OPD Block, SMS Medical college and attached Hospitals, JLN Marg, Jaipur- 302004, Rajasthan, India Jaipur RAJASTHAN
9829135692
drajeetsingh@yahoo.com
Dr Vulli Venkatesh
Visakha Institute of Medical Sciences
Maharanipeta Visakhapatnam - 530002, Andhra Pradesh, India. Visakhapatnam ANDHRA PRADESH
9490487605
drvvenkateshresearch@gmail.com
Dr Kunjir Nana Gokul
Vishwaraj Hospital
Pulmonology Department, Vishwaraj Hospital, Gate no.499, Kadarnvak Vasti, Solapur Road, Loni Kalbhor. Pune Maharashtra- 412201, India Pune MAHARASHTRA
FDC of Fluticasone Furoate, Umeclidinium and Vilanterol powder for inhalation (200mcg + 62.5mcg + 25mcg)
Capsules are to be used through Octahaler for inhalation once daily. Capsules are not to be swallowed, crushed or chewed. Capsules are to be used at the same time every day. Capsules are not to be used more than 1 time every 24 hours
Comparator Agent
FDC of Indacaterol [as acetate], Glycopyrronium and
Mometasone furoate powder for inhalation (150mcg + 50mcg + 160mcg)
Capsules are to be used through Dry powder inhaler
for inhalation once daily. Capsules are not to be
swallowed, crushed or chewed. Capsules are to be used at the same time every day. Capsules are not to be used more than 1 time every 24 hours.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Patient will be included if all the inclusion criteria listed below are met:
1. Patients of either gender with age between 18 to 65 years (both inclusive) and willing to provide written informed consent
2. Patients with a diagnosis of bronchial asthma as per GINA 2024 for a period of at least 1 year prior to Screening
3. Patients who have symptomatic uncontrolled bronchial asthma after using medium or high dose of inhaled corticosteroids (ICS) and long-acting beta-2 agonists (LABA) combinations for asthma for at least 3 months and at stable dose for at least 1 month prior to Screening
4. In pre-bronchodilator spirometry, patients with trough Forced expiratory volume in one second (FEV1) of 40% to 80% of the predicted normal value for the patient
5. In post-bronchodilator spirometry, patients who demonstrate an increase in FEV1 OR Forced vital capacity (FVC) of greater than or equal to 12% AND greater than or equal to 200 mL from pre-bronchodilator reading
6. Patients with documented history of at least one asthma exacerbation which required medical care from a physician or visit to emergency (or local equivalent structure) or hospitalization within 12 months prior to Screening (but no exacerbation within 6 weeks prior to Screening) or documented temporary change in asthma therapy for exacerbation
7. Women of childbearing potential must have a negative urine pregnancy test prior to Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of study (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence OR non-hormonal contraception [e.g. condoms with spermicide])
[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Post-menopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age]
8. Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period) [No sperm donation is allowed during the study period]
ExclusionCriteria
Details
Patients will be excluded if any of the exclusion criteria listed below is met:
1. Patients with known hypersensitivity or any other contraindication to any of the Investigational products or any of its components
2. Patients with history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis and clinically significant bronchiectasis
3. Patients with history of active pulmonary or extra-pulmonary tuberculosis within 1 year prior to Screening OR a positive report on QuantiFERON TB Gold test at Screening
4. Patients with history of intubation for a severe asthma attack/exacerbation
5. Patients with history of acute respiratory tract infection within 4 weeks prior to Screening OR during the Run-in period
6. Patient with oropharyngeal candidiasis within 4 weeks prior to Screening OR during the Run-in period
7. Patients with history of Immunotherapy (desensitization) for allergies within 3 months prior to Screening
8. Patients with history of irregular sleep-wake cycle
9. Patients with history of any chronic conditions affecting the upper respiratory tract (like but not limited to: chronic sinusitis, nasal polyp, etc.)
10. Patients treated with parenteral corticosteroids (except systemic corticosteroids for treatment of asthma exacerbation) within 4 weeks prior to Run-in visit OR intramuscular depot corticosteroids within 3 months prior to Run-in visit
11. Patients with history of live/ live attenuated vaccination within 4 weeks prior to Screening or planning for vaccination during the course of the study or within 4 weeks after study completion
12. Patients treated with asthma medications but not meeting the required stable dosing period
13. Patients with history of any clinically significant medical and/or psychological condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results [for example but not limited to: renal impairment (if serum creatinine greater than or equal to 2 x ULN), cardiovascular disorders (like: ischemic heart disease, NYHA Class III/IV left ventricular failure, arrhythmia, atrial fibrillation, myocardial infarction, angina, congestive heart failure, long QT syndrome, etc.), cerebrovascular disease, ophthalmologic disease, psychiatric disorder, neurodegenerative disease, epilepsy or seizure disorder or any neurological disorder, any autoimmune disorders, uncontrolled thyroid disorder, hypokalemia (serum potassium lesser than 3.5 mEq/L), hepatic impairment (if ALT greater than or equal to 3 x ULN OR AST greater than or equal to 3 x ULN OR ALP greater than or equal to 3 x ULN OR total bilirubin greater than or equal to 1.5 x ULN)]
14. Patients with Type I diabetes mellitus or uncontrolled Type II diabetes mellitus (HbA1c greater than or equal to 9%)
15. Patients with prolonged QTcF [greater than 450 ms in males and greater than 460 ms in females] in 12-lead ECG or any other clinically significant abnormal ECG findings at Screening
16. Patients with history of severe narcolepsy or insomnia
17. Pregnant and/or lactating female
18. Patient with history of HIV and/or HBV and/or HCV infection
19. Patients who have smoked or inhaled tobacco products (including nicotine inhalers like e-cigarettes) within 6 months prior to Screening
20. Patients with known alcohol or any other substance abuse within last one year prior to Screening
21. Patients with history of any malignancy in the last 5 years prior to Screening or undergoing cancer chemo or radiotherapy
22. Patients who have participated in another Investigational study within the 3 months prior to Screening or planning to participate in another clinical trial during the study
23. Employee of the Sponsor, Investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees of Sponsor or the Investigator
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change from baseline in trough FEV1
Baseline, Week 12
Secondary Outcome
Outcome
TimePoints
Change from baseline in trough FVC
Baseline, Weeks 4, 8 and 12
Change from baseline in trough FEV1/FVC
Baseline, Weeks 4, 8 and 12
Change from baseline in post-dose FEV1
Baseline, Week 12
Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) total score
Baseline, Week 12
Proportion of participants with treatment emergent (TEAEs) and serious adverse events (SAEs)
Throughout the study period
Target Sample Size
Total Sample Size="336" Sample Size from India="336" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
04/06/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="4" Days="5"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
This will be a phase III, randomized, parallel-group, multi-center, open-label, two-arm, active-controlled, comparative study to assess the safety and efficacy of FDC of Fluticasone Furoate, Umeclidinium and Vilanterol (200 mcg + 62.5 mcg + 25 mcg) Compared to FDC of Indacaterol, Glycopyrronium and Mometasone Furoate (150 mcg + 50 mcg + 160 mcg) in Patients with Bronchial Asthma. Approximately 336 patients (168 patients in each arm) will be enrolled in the study from various parts of India. The study will be initiated only after the receipt of Regulatory and Ethics committee (EC) approvals.
After obtaining the informed consent, patients will be screened by undergoing various assessments. Patients taking any prohibited medications will be discontinued from such medication and will undergo washout period. After completion of screening and washout patients will be reassessed for eligibility at Run-in visit and eligible patients will then enter a Run-in period of 2 weeks. The run-in period is done for standardization of the patients on dual drug therapy. Patients will be reassessed for eligibility at Run-in visit. After confirming the eligibility, patients will be randomized by allotting the randomization number in a ratio of 1:1. Patients will be either randomized to Test arm OR to Comparator arm. The randomized patients will take the study medication once daily as instructed for 12 weeks (Treatment period) followed by a 2 weeks Safety follow-up period.