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CTRI Number  CTRI/2025/12/098826 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 28/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A phase IV study to evaluate efficacy and safety of Vilanterol, Glycopyrronium and Fluticasone furoate powder for Inhalation in participants with Chronic Obstructive Pulmonary Disease (COPD) 
Scientific Title of Study   A prospective, open label, single-arm, multicentre, phase IV clinical trial to assess efficacy and safety of Vilanterol, Glycopyrronium and Fluticasone furoate powder for Inhalation in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
24-04 Version 00 dated 24/06/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deven V Parmar 
Designation  Chief medical officer & Head – Clinical R & D 
Affiliation  Zydus Healthcare Ltd. 
Address  Zydus Research Centre, Sarkhej- Bavla N.H. No.8A, Moraiya, Ahmedabad-382213

Ahmadabad
GUJARAT
382213
India 
Phone  02717665555  
Fax    
Email  dparmar@zydustherapeutics.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hardik Pathak 
Designation  General Manager – Clinical R & D 
Affiliation  Zydus Healthcare Ltd. 
Address  Zydus Research Centre, Sarkhej- Bavla N.H. No.8A, Moraiya, Ahmedabad-382213

Ahmadabad
GUJARAT
382213
India 
Phone  02717665555  
Fax    
Email  Hardik.L.Pathak@zyduslife.com  
 
Details of Contact Person
Public Query  
Name  Dr Nidhi Singh 
Designation  Head Clinical Operations  
Affiliation  Clinical Research Network India Pvt Ltd  
Address  B-806,807, Advant Navis Business Park #Plot #7, Noida-Greater Noida Expressway Sector 142, Noida, Delhi-NCR
B-806, 807, Advant Navis Business Park, Plot 7, Noida-Greater Noida Expressway, Sector 142, Noida, Delhi-NCR
Gautam Buddha Nagar
UTTAR PRADESH
201305
India 
Phone  09695237796  
Fax    
Email  nidhisingh@crnindia.org   
 
Source of Monetary or Material Support  
Zydus Healthcare Limited (Unit II), 967 (P), 968 (P), 970 (P), Duga Circle, Kamarey Bhasmay, Kumrek, Sikkim-737132 
 
Primary Sponsor  
Name  Zydus Healthcare Ltd. 
Address  Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad – 382481, Gujarat, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chintan B Patel  Aatman Hospital   1st Floor, 5, Anveshan Row House. Opp. Umiya Mata Mandir, Bopal-Ghuma Main Road, Bopal, Ahmedabad-380058
Ahmadabad
GUJARAT 		 9825182251

drchintan.cr@gmail.com 
Dr Sandeep Katiyar  Apollo Spectra Hospitals  Apollo Spectra Hospitals, 14/138, Chunni Ganj Kanpur-208001, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH 		 8090609630

skkatiyarin@gmail.com 
Dr Santosh Honnavar  Belagavi Institute of Medical Sciences  Department of Pulmonology, Belagavi, Dr B R Ambedkar Road, Belagavi-590001
Belgaum
KARNATAKA 		 9964451057

honnavar.santosh@gmail.com 
Dr Amit S Bhate  Bhate Hospital  CTS No. 4830/13/14, Dr. B R Ambedkar Road, Opp. Civil Hospital, Belagavi-590002
Belgaum
KARNATAKA 		 8197940086

dr.amitsureshbhate@gmail.com 
Dr Anjali R Nath  Citizen Hospital  Citizen Hospital, 14,2nd Manin Dispensary Road, Kalasipalya, Bangalore 560002, Karnataka, India
Bangalore
KARNATAKA 		 9995395041

anjali.madh@gmail.com 
Dr Saugata Bhaumik  College of Medical & Sagore Dutta Hospital  Department of Chest Medicine 578, B.T. Road, Kamarhati, Kolkata-700058, West Bengal, India
Kolkata
WEST BENGAL 		 9883555307

saugataaiims2012@gmail.com 
Dr Avdhesh Kumar  GSVM Medical College  Department of Pulmonary, Murari Lal Chest Hospital, Swaroop Nagar, Kanpur-208002, Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH 		 7408441504

dravikumar1001@gmail.com 
Dr Jyothi Hattiholi  KLEs Prabhakar Kore Hospital  Department of Respiratory Medicine, Nehru Nagar, Belagavi-590010, Karnataka, India
Belgaum
KARNATAKA 		 9164012011

pulmojyoti@gmail.com 
Dr Raja Bhattacharya   Medical College and Hospital  Department of Medicine, MCH Building, 4th Floor, 88 college street Kolkata-700073, W.B. India
Kolkata
WEST BENGAL 		 8100273048

rbrbhattacharya@gmail.com 
Dr Amitabh Das Shukla  MLN Medical College  Department of Pulmonology, Prayagraj (Allahabad), Uttar Pradesh
Allahabad
UTTAR PRADESH 		 9335867395

adshukla1977@yahoo.com 
Dr Jitendra Singh Kushwaha  Prakhar Hospital Pvt. Ltd.  Prakhar Hospital Pvt. Ltd.,8/219 Arya Nagar Kanpur 208002, Uttar Pradesh, India.
Kanpur Nagar
UTTAR PRADESH 		 9415040752

dr.jskushwahacr@gmail.com 
Dr Vijaykumar B Barge  Rajarshee Chhatrapati Shahu Maharaj Government Medical College  CPR Hospital Dasara Chowk, Bhausinghaji Road, Kolhapur, Townhall 416012, Maharashtra India
Kolhapur
MAHARASHTRA 		 7969792775

drvijaybarge12@gmail.com 
Dr Sudipta Pandit  SNP Hospital  11 Lala Lajpat Rai Sarani, Department of Pulmonary Medicine, Kolkata-700020, West Bengal, India
Kolkata
WEST BENGAL 		 9433408280

drsudiptapandit@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
ACEAS-Independent Ethics Committee  Approved 
Apollo Specialty Hospitals Kanpur EC  Approved 
College of Medicine and Sagore dutta Hospital  Submittted/Under Review 
ECR//1591/Inst/KA/2021  Approved 
ECR/1017/Inst/UP/2017/RR-21  Approved 
ECR/703/Inst/MH/2015/RR-20  Approved 
ETHICS COMMITTEE GSVM Medical College  Submittted/Under Review 
Ethics Committee Jeevan Rekha Hospital  Submittted/Under Review 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee for Human Research  Submittted/Under Review 
IPGME and R Research Oversight Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Vilanterol, Glycopyrronium and Fluticasone furoate capsule  Vilanterol, Glycopyrronium and Fluticasone furoate Inhalation 25 mcg, 50 mcg and 100 mcg (Dry Powder Inhalation- DPI) to be inhaled 1 capsule daily for 12 Weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of either gender between 40-65 years of age (both inclusive)
2. Patients who are current or ex-smokers
3. Patients diagnosed with moderate to severe COPD as per the GOLD guidelines classification at screening visit:
a. Post-bronchodilator FEV1/FVC ratio less than 0.7;
b. Post-bronchodilator FEV1, more than or equal to 30% to less than 80% predicted
4. Clinically stable COPD (patient shall be taking at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) within 4 weeks prior to the screening visit and during the screening period
5. COPD Assessment Test (CAT) score more than or equal to 10 at screening
6. Patients willing to provide written informed consent and comply with the protocol requirements
7. Patients literate enough to fill the diary card 
 
ExclusionCriteria 
Details  1. Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.
2. Patients with known hypersensitivity to vilanterol, glycopyrronium, fluticasone, salbutamol, other beta-2 agonists or other anti-muscarinic agents
3. Patients diagnosed with COVID-19 within 3 months prior to screening
4. Patients with known alpha1 antitrypsin deficiency
5. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
6. Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period
7. Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period
8. Patients who required long-term oxygen therapy (more than equal to 12 hours/day) within 4 weeks prior to the screening or during the screening period
9. Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention
10. Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy
11. Patients with hepatic dysfunction (serum transaminases more than equal to 3 times of Upper Normal Limit) or renal dysfunction (serum creatinine more than equal to 2.5 mg/dl) at screening
12. Patients who have used prohibited medications
13. Patients with continuing history of alcohol and/or drug abuse
14. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
15. Participation in another clinical trial in the past 3 months
16. Any other reason for which the investigator feels that the patient should not participate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change from baseline in trough FEV1 at the end of the study  At 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy:
Change from baseline in trough FEV1 at week 4
Change from baseline in trough FVC at week 4 & at the end of the study
Change from baseline in post-bronchodilator FEV1 & FVC at week 4 & at the end of the study
Change from baseline in CAT™ score at week 4, week 8 & at the end of the study
Responder rate at week 4 & at the end of the study
COPD exacerbations reported during the study
Rescue medication use during the treatment period

Safety:
Adverse events reported during the study
Serious adverse events reported during the study 		 At week 4, week 8 & at the end of the study 
 
Target Sample Size   Total Sample Size="234"
Sample Size from India="234" 
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 4 
Date of First Enrollment (India)   20/12/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
In this study, the efficacy and safety of FDC of Vilanterol, Glycopyrronium and Fluticasone furoate Inhalation (DPI) 25 mcg, 50 mcg and 100 mcg (Test drug) will be evaluated in patients with moderate to severe COPD. The drug in form of capsule to be inhaled once daily. All the enrolled patients will be instructed to take the test drug for the treatment period of 12 weeks. In this study, the patients with moderate to severe COPD receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) will be screened (visit 1) within 7 days prior to their enrolment. The eligible patients will then be enrolled to test drug on baseline visit (visit 2, day 0). After enrolment, patients will then be followed up on an outpatient basis with scheduled visits at week 4 (visit 3), week 8 (visit 4) and week 12 (visit 5). 
 
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