CTRI/2026/04/107954 [Registered on: 09/04/2026] 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
A clinical trial to study the effects of a metered dose inhaler having a combination of Fluticasone Furoate, Umeclidinium, and Vilanterol inhalation in Chronic Obstructive Pulmonary Disease (COPD) participants
Scientific Title of Study
Efficacy and Safety of Single-Inhaler Triple Therapy (SITT) of Fluticasone Furoate, Umeclidinium and Vilanterol inhalation– (50 mcg/31.25 mcg/12.5 mcg) Metered dose inhaler (MDI) versus SITT of TRELEGY ELLIPTA, Dry powder inhaler (DPI) [Fluticasone Furoate, Umeclidinium and Vilanterol Powder for oral inhalation – (100 mcg/62.5 mcg/25 mcg)] in Chronic Obstructive Pulmonary Disease (COPD) participants: A Multi-center, Randomized, Open-label, Comparative, Parallel Group Study.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
LMDI0301 version 2.0 dated 04-Sep-2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Pramod Kadam
Designation
Manager – Medical Services
Affiliation
Lupin Limited
Address
5th Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz East, Mumbai- 400055, Maharashtra, India
Mumbai MAHARASHTRA 400055 India
Phone
9011202149
Fax
Email
pramodvkadam@lupin.com
Details of Contact Person Scientific Query
Name
Dr Kundan Nivangune
Designation
Senior Manager – Medical Services
Affiliation
Lupin Limited
Address
5th Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz East, Mumbai- 400055, Maharashtra, India
Mumbai MAHARASHTRA 400055 India
Phone
7756929466
Fax
Email
kundannivangune@lupin.com
Details of Contact Person Public Query
Name
Pramod Kadam
Designation
Manager – Medical Services
Affiliation
Lupin Limited
Address
5th Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz East, Mumbai- 400055, Maharashtra, India
Mumbai MAHARASHTRA 400055 India
Phone
9011202149
Fax
Email
pramodvkadam@lupin.com
Source of Monetary or Material Support
Lupin Limited
5th Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz East, Mumbai- 400055, Maharashtra, India
Primary Sponsor
Name
Lupin Limited
Address
5th Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz East, Mumbai- 400055, Maharashtra, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
MsLupin Limited
EPIP, Kartholi, SIDCO, Industrial Complex, Bari Brahmana, Jammu and Kashmir, India-181133
Countries of Recruitment
India
Sites of Study
No of Sites = 18
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Phophale Himanshu Shashikant
ACE Hospital and Research Center
Research Staff Room, 3rd floor. 32/2 A, Erandawane, Gulwani Maharaj Road
Pune, Maharashtra - 411004 India Pune MAHARASHTRA
9503939461
phophalehimanshu@yahoo.co.in
Dr Saugata Bhaumik
College Of Medicine & Sagore Dutta Hospital
Ground Floor, Medical Research Room,
578, BT Road, Kamarhati, Kolkata - 700058, West Bengal, India Kolkata WEST BENGAL
9883555307
sugataaiims2012@gmail.com
Dr Karthik Velimala
Government General and Chest Hospital
OPD Building, Second Floor,
Government General and Chest Hospital,
Pulmonology department, Irrumnama, Hyderabad 500038, Telangana, India Hyderabad TELANGANA
9849424240
vkarthikrao19@gmail.com
Dr Rashmi Upadhyay
Government Institute of Medical Sciences (GIMS)
OPD building, 4th floor, Room no. 448 & 453, Clinical Trial Unit, Greater Noida, Gautam Buddha Nagar, Noida, UP, India - 201310 Gautam Buddha Nagar UTTAR PRADESH
9918002313
rash.georgian@gmail.com
Dr Kushwaha Jitendra Singh
GSVM Medical College
Ground Floor, Post Graduate Department of Medicine, Swaroop Nagar, Kanpur, UP - 208002, India Kanpur Nagar UTTAR PRADESH
Clinical Trial Unit, Room No 6, No 9, 1st Main Rd, United India Colony, Kodambakkam, Chennai, Tamil Nadu- 600024, India Chennai TAMIL NADU
9500049868
dr.suprajak.medwaystudies@gmail.com
Dr Jitendra Shukla
Motilal Nehru Medical College
Ground floor, Room no. 101, George town, Prayagraj Allahabad, UP-211002,
India Allahabad UTTAR PRADESH
8527483333
drjitendramln@gmail.com
Dr Priyanka Ray
Nil Ratan Sarcar Medical College and Hospital (NRS)
138, Acharya Jagdish Chandra Bose Road, Sealdah, Raja Bazar, Kolkata, West Bengal, India - 700014 Kolkata WEST BENGAL
9433360494
raydrpriyanka9@gmail.com
Dr Krishna Prasad Anne
Pranaam Hospitals Pvt Ltd
Clinical Research Department, 1-56/6/40 & 41, Pranaam Hospital Lane Mythri Nagar, Madinaguda, Miyapur, Hyderabad, Telangana, India - 500050 Hyderabad TELANGANA
9481149190
krishnaprasadanne@gmail.com
Dr Prashanth C
Princess Krishnajammanni Tuberculosis and Chest Diseases Hospital
Department of Respiratory Medicine Room # 10 (Attached to Government Medical College, Mysore) K.R.S. Road, Mysore, Karnataka, India - 570002 Mysore KARNATAKA
8147299390
prshnthcr@gmail.com
Dr Nikalje Rajkumar Gautam
Punawale Multispeciality Hospital
Clinical Research Department, 3rd floor. Alpha Heights Vishnu Dev Nagar, Jambe road, Near Khandoba Mandir, Punawale, Pune, Maharashtra - 411033 Pune MAHARASHTRA
9028560535
rajkumar.nikalje23@gmail.com
Dr Sudipta Pandit
Sambhunath Pandit Hospital a Unit of IPGME&R/ SSKM Hospital
Ground Floor, Department: Pulmonary Medicine, 244 Acharya J. C. Bose Road, Kolkata, West Bengal, India - 700020
Kolkata WEST BENGAL
9433408280
drsudiptapandit@gmail.com
Dr Shrikant Hiremath
Sanjeevini Speciality Hospital and Heart Care Center
OPD:02, First floor, Department of Respiratory Medicine, Shirur Park Main Road, Prashanth colony, Vidyanagar, Hubli, Karnataka, India - 580031 Dharwad KARNATAKA
Subject will be taking the study medication (Fluticasone Furoate, Umeclidinium and Vilanterol Powder for oral inhalation (100 mcg/62.5/mcg/25 mcg) marketed by GSK) up to 91 days
Intervention
SIT MDI (FDC)
Subject will be taking the study medication(Fluticasone Furoate, Umeclidinium, and Vilanterol inhalation– (50 mcg /31.25 mcg/12.5 mcg) (MDI, Mfg. by Lupin Ltd) up to 91 days
Inclusion Criteria
Age From
40.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Male or female participants, aged grater than or equal to 40 years at screening.
2. Participants with a diagnosis of COPD (as defined by the GOLD COPD report 2025).
3. Post-bronchodilator FEV1 grater than or equal to 30% and less than 80% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) ratio less than 0.70
4. A modified Medical Research Council dyspnea scale (mMRC) grade grater than or equal to 2.
5. COPD Assessment Test (CAT) score greater than or equal to 10 even after receiving at least two inhaled maintenance therapies (LABA Plus LAMA or LABA Plus ICS) for at least 4-6 weeks at the time of screening.
6. History of exacerbations (greater than or equal to 2 moderate or greater than or equal to 1 severe exacerbation) of COPD within 12 months before screening.
7. Subjects on inhaled corticosteroid (ICS) with or without a long-acting beta2 agonist (LABA) (as a free or fixed combination), or ICS with a long-acting muscarinic antagonist (LAMA), or LABA with LAMA (as a free or fixed combination), or LAMA monotherapy as maintenance treatment for at least 1 month before screening.
8. Willingness to give their written informed consent to participate in the study and willingness to comply with study requirements and procedures.
9. Female subjects with negative pregnancy tests, and agreed to use adequate forms of non-hormonal contraception during the study (i.e. women of childbearing potential used a highly effective method of birth control, such as condom and spermicide, diaphragm or cervical cap and spermicide, condom and diaphragm or cervical cap, non-hormonal IUD), or females who were of non-child bearing potential i.e. who were surgically sterile (history of hysterectomy or bilateral tubal ligation or bilateral oophorectomy; partial hysterectomy is not sufficient or vasectomized partner) or postmenopausal (12 months of spontaneous amenorrhea), or who agreed to remain abstinent.
10. Ability to use the test and reference products independently and correctly as instructed by the investigator.
ExclusionCriteria
Details
1. Participant unable to perform study procedures or not willing to give informed consent.
2. Participants already receiving triple drug treatment with LABA Plus LAMA Plus ICS (either in the form of SITT or MITT).
3. Participants with co-existing comorbidities such as tuberculosis, alpha-1 antitrypsin deficiency, cystic fibrosis, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease.
4. Evidence or history of other clinically significant cardiovascular disease or abnormality (such as, but not limited to, congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infraction, arrhythmia, long QT syndrome, atrial fibrillation), renal, neurological, endocrine, immunological, psychiatric, hepatic, or hematological disease or abnormality which, in the opinion of the investigator, will clinically significant and have put the patient at risk through study participation, or would have affected the study analyses if the disease exacerbates during the study.
5. Significant abnormality that suggests chest disease other than COPD, on chest X-ray or computed tomography (CT) scan taken within six months before screening. If there was no chest X-ray/CT scan taken within six months prior to screening, a chest X-ray will be performed during screening to rule out any other significant abnormality.
6. History of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction, severe renal impairment or urinary retention, or any other condition, which, in the opinion of the investigator, would have contraindicated the use of an anticholinergic or long-acting beta agonist agent.
7. History of allergy or hypersensitivity to any of the ingredients of study drugs or components of the delivery system.
8. Hospitalization for COPD exacerbation or pneumonia within three months prior to screening.
9. Use of oral/parenteral corticosteroids or antibiotics for COPD exacerbation within six weeks prior to screening.
10. A clinically significant abnormal electrocardiogram (ECG) at screening.
11. Lung volume reduction surgery within 12 months prior to the initiation of the study.
12. Requirement of long-term (greater than 12 hours daily) oxygen therapy.
13. Unable to stop the following medications at the defined times prior to screening spirometry:
a. Ipratropium or ipratropium/salbutamol combination product: 8 hours, Inhaled short-acting beta-agonists 6 hours, Oral beta 2-agonists 48 hours, Long acting beta agonists (salmeterol and formoterol) or ICS/LABA combination products: 48 hours, Xanthines: 48 hours, Cromolyn and nedocromil inhalers 24 hours
b. Zafirlukast, montelukast, zileuton: 48 hours
Long-acting anticholinergics (Tiotropium etc.): 48 hours
c. Oral or parenteral corticosteroids: 6 weeks
d. Any other investigational medication 30 days or 5 half-lives of the investigational drug (whichever is longer),
e. Depot corticosteroids: 3 months,
f. Inhaled corticosteroids (ICS): Washout not required
14. Currently enrolled in another interventional clinical study or have used any IPs, study drug, or device within 30 days or 5 times the half-life, whichever is longer, preceding informed consent or scheduled to participate in another clinical study involving an IP.
15. Participants who are currently taking alcohol products.
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Mean change of FEV1
Baseline to Week 12
Secondary Outcome
Outcome
TimePoints
Mean change of FEV1
Baseline to End of Week 4
Mean change of 2 hours post-dose FEV1
Baseline to Week 12
Proportion of participants requiring the use of rescue medication over the treatment period. Salbutamol/Levosalbutamol will be provided in rescue medication
Baseline to Week 12
Proportion of participants with COPD exacerbations
Baseline to Week 12
Mean change of mMRC Dyspnea score
Baseline to Week 4 and Week 12
Incidence of TEAEs
Baseline to Week 12
Target Sample Size
Total Sample Size="230" Sample Size from India="230" 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)
20/04/2026
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="2" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
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)?
Response - NO
Brief Summary
Chronic obstructive pulmonary disease (COPD) is a progressive chronic disease which is subject to acute exacerbations. COPD is a multicomponent integration of chronic and progressive illnesses, characterized by airway obstruction, inflammation, hyperinflation and acute-on-chronic exacerbations. Airway obstruction in COPD is an important cause of exertional breathlessness. It slowly progresses to marked disability and respiratory failure to limit the daily activities of an individual, finally confining him to bed.
COPD is a multicomponent disease that also affects the systems and organs outside the lungs. These systemic effects of COPD include weight loss, muscle dysfunction and cardiovascular disease. The subjects with COPD have a lower physical activity level even earlier in the disease process.
The Purpose of the study is to Efficacy and Safety of Single-Inhaler Triple Therapy (SITT) of Fluticasone Furoate, Umeclidinium and Vilanterol inhalation– (50 mcg/31.25 mcg/12.5 mcg) Metered dose inhaler (MDI) versus SITT of TRELEGY ELLIPTA, Dry powder inhaler (DPI) [Fluticasone Furoate, Umeclidinium and Vilanterol Powder for oral inhalation – (100 mcg/62.5 mcg/25 mcg)] in Chronic Obstructive Pulmonary Disease (COPD) participants