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CTRI Number  CTRI/2025/06/089209 [Registered on: 20/06/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   study to assess the efficacy and safety of Glycopyrronium and Indacaterol inhalation in patients with Chronic Obstructive Pulmonary Disease. 
Scientific Title of Study   A Prospective, Randomized, Double-blind, Parallel, Active-controlled, Multicentre, Phase III clinical trial to assess the efficacy and safety of Glycopyrronium and Indacaterol inhalation as compared to Vilanterol and Glycopyrronium inhalation in patients with Chronic Obstructive Pulmonary Disease. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No.: GLIN.24.001 Version: 01 Date: 13 Jan 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dharmesh Domadia 
Designation  Vice President - Global Clinical Operations 
Affiliation  Cliantha Research Limited 
Address  Cliantha Research Limited, Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India

Ahmadabad
GUJARAT
382210
India 
Phone  2717698500  
Fax    
Email  ddomadia@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ankesh Barnwal 
Designation  Associate Director - II 
Affiliation  Cliantha Research Limited 
Address  Cliantha Research Limited, Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India

Ahmadabad
GUJARAT
382210
India 
Phone  07966219500  
Fax    
Email  abarnwal@cliantha.com  
 
Details of Contact Person
Public Query  
Name  Mr Devesh Verma 
Designation  Director 
Affiliation  Cliantha Research Limited 
Address  Cliantha Research Limited, Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India

Ahmadabad
GUJARAT
382210
India 
Phone  9712908404  
Fax    
Email  dverma@cliantha.com  
 
Source of Monetary or Material Support  
Zydus Lifesciences Limited, Zydus Research Centre, Survey No. 396/403, Sarkhej-Bavla National Highway No. 8A Moraiya, Ahmedabad – 382213, Gujarat, India 
 
Primary Sponsor  
Name  Zydus Lifesciences Limited 
Address  Zydus Healthcare Limited (Unit II), 967(P), 968 (P), 970 (P), Duga Circle, Kamarey Bhasmay, Kumrek, Sikkim - 737132  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Santosh Honnavar  Belagavi Institute of Medical Sciences  OPD no. 60, Ground Floor, Clinical Research Room, Department of Respiratory Medicine, Dr Ambedkar Road, Sadashiv Nagar, Belagavi - 590001, Karnataka
Belgaum
KARNATAKA 		 9964451057

Honnavar.santosh@gmail.com 
Dr Amit Bhate  Bhate Hospital  4th floor, CRC Room, Clinical Research Department, CTS No. 4830/13/14, Dr. B. R. Ambedkar Road, Opposite Civil Hospital, Belagavi - 590002, Karnataka
Belgaum
KARNATAKA 		 8197940086

Dr.amitsureshbhate@gmail.com 
Dr Arti Shah  Dhiraj Hospital, Smt. B.K.SHAH Medical Institute and Research Centre  Clinical Research Department, Clinical Research Room, Third Floor, affiliated to Sumandeep Vidyapeeth Deemed to be University, At & Po. Piparia, Ta. Waghodia, Vadodara - 391760, Gujarat, India
Vadodara
GUJARAT 		 9925047880

Hod_pul_med@sumandeepvidyapeethdu.edu.in 
Dr Sahoo Srinibas  Hi-Tech Medical College and Hospital  Ground Floor, PG Department of Respiratory Medicine, Health Park, Pandara, Bhubaneswar - 751025, Odisha
Khordha
ORISSA 		 9437268909

Srinibassahoo051@gmail.com 
Dr Manish Kumar Jain  Maharaja Agrasen Superspeciality Hospital  Room No. 105, Ground Floor, Clinical Research department, Central Spine, Agrasen Aspatal Marg, Sector - 7, Vidyadhar Nagar, Jaipur - 302039, Rajasthan
Jaipur
RAJASTHAN 		 9414414834

Doctormanishjain2@gmail.com 
Dr Sanjaykumar Verma  Murarilal Chest Hospital, GSVM Medical College  Ground Floor, Room no. 07 and 08, Department of Pulmonary, Swaroop Nagar, Kanpur - 208002, Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH 		 9415075458

vermasanjayko@gmail.com 
Dr Pankaj Vyas  Namostute Hospital  Basement 2, Clinical Research Room, Clinical Research Department, Plot No-1285, Sector-6-D, Gh-3, Circle, Opp. Civil Hospital, Gandhinagar - 382006, Gujarat, India
Gandhinagar
GUJARAT 		 9726630128

Drpankajvyas.researchcr@gmail.com 
Dr Aman Ahuja  Pt. B.D Sharma Post Graduate Institute of Medical Sciences  Clinical Research Department, Clinical Research Room, Room No. 1, Rohtak-124001, Haryana, India
Rohtak
HARYANA 		 8290470844

Aman2027@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Ethics Committee Jeevan Rekha Hospital  Submittted/Under Review 
Ethics Committee, GSVM Medical College  Approved 
IEC, Shashvat Surgicare Hospital  Approved 
Institute Ethics Committee, Belagavi Institute of Medical Sciences  Approved 
Institute Ethics Committee, Maharaja Agrasen Superspeciality Hospital  Approved 
Institutional Ethics Committee, Hi-Tech Medical College & Hospital  Submittted/Under Review 
Institutional Ethics Committee, PGIMS UHS Rohtak  Approved 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
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 
Intervention  Glycopyrronim and Indacaterol inhalation 25 mcg and 55 mcg  Participants will be dispensed one MDI each of Glycopyrronium and Indacaterol inhalation 25 mcg and 55 mcg during visit 2 (day 0), visit 3 (week 4) and visit 4 (week 8) and advised to take 2 actuations once daily preferably same time every day through oral inhalation route which will ultimately provide a total daily dose of Glycopyrronium 50 mcg and Indacaterol 110mcg. Treatment should be continued for 12 weeks. 
Comparator Agent  Vilanterol and Glycopyrronim inhalation 12.5 mcg and 25 mcg  Participants will be dispensed one MDI each of Vilanterol and Glycopyrronium inhalation 12.5 mcg and 25 mcg during visit 2 (day 0), visit 3 (week 4) and visit 4 (week 8) and advised to take 2 actuations once daily preferably same time every day through inhalation route which will ultimately provide a total daily dose of Vilanterol 25 mcg and Glycopyrronium 50 mcg. Treatment should be continued for 12 weeks. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Participants of either gender between 40-65 years of age (both inclusive)
2. Participants who are current/ex-smokers
3. Participants 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, greater than or equals to 30 percent to less than 80 percent predicted
4. Clinically stable COPD within 4 weeks prior to the screening visit and during the screening period
5. COPD Assessment Test (CAT) score greater than or equals to 10 at screening
6. Participants willing to provide written informed consent and comply with the protocol requirements
7. Participants literate enough to fill the diary card
 
 
ExclusionCriteria 
Details  1. Participants suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.
2. Participants with known hypersensitivity to indacaterol, vilanterol, glycopyrronium, salbutamol, other beta-2 agonists or other anti-muscarinic agents
3. Participants with known alpha 1 antitrypsin deficiency
4. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
5. Participants hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period
6. Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period
7. Participants who required long-term oxygen therapy (greater than or equals to 12 hours/day) within 4 weeks prior to the screening or during the screening period
8. Participants with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder neck obstruction or urinary retention.
9. Participants with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy
10. Participants with hepatic dysfunction (serum transaminases greater than or equals to 3 x Upper Normal Limit) or renal dysfunction (serum creatinine greater than or equals to 2.5 mg/dl) at screening
11. Participants who have used prohibited medications
12. Participants with continuing history of alcohol and/or drug abuse
13. Pregnant or Lactating females; or female participants of childbearing potential or male participants unwilling to use effective contraception during and 1 month after completion of the study. Male participants who are unwilling to not donate sperm for the purpose of reproduction.
14. Participant participated in any clinical trial in the past 3 months
15. Any other reason for which the investigator feels that the participant should not participate
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from baseline in trough FEV1  At week 12 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change from baseline in trough FEV1
2. Change from baseline in trough FVC
3. Change from baseline in post-bronchodilator FEV1 and FVC
4. Change from baseline in CAT score
5. Responder rate
6. Rescue medication use
7. COPD exacerbations
8. Global impression of change in the disease condition of participants
 		 1. At week 4
2. At week 4 & At week 12
3. At week 4 & At week 12
4. At week 4, week 8 and at week 12
5. At week 4 and at week 12
6. During the treatment period as compared to the baseline
7. During the study
8. At week 12
 
 
Target Sample Size   Total Sample Size="274"
Sample Size from India="274" 
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)   24/06/2025 
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="1"
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   A Prospective, Randomized, Double-blind, Parallel, Active-controlled, Multicentre, Phase III clinical trial to assess the efficacy and safety of Glycopyrronium and Indacaterol inhalation as compared to Vilanterol and Glycopyrronium inhalation in patients with Chronic Obstructive Pulmonary Disease. 
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