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CTRI Number  CTRI/2024/10/075606 [Registered on: 22/10/2024] Trial Registered Prospectively
Last Modified On: 12/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to understand safety and effectiveness of fixed dose combination of Glycopyrronium 25 µg, Formoterol Fumarate 20 µg, Budesonide 500 µg inhalation suspension. 
Scientific Title of Study   A randomized, double-blind, double-dummy clinical trial to assess the efficacy and safety of fixed dose combination of Glycopyrronium 25 µg, Formoterol Fumarate 20 µg, Budesonide 500 µg Inhalation Suspension (for nebulization) in comparison with fixed dose combination of Formoterol Fumarate Dihydrate 5 µg, Glycopyrronium 7.2 µg and Budesonide 160 µg pressured inhalation suspension in patients with chronic obstructive pulmonary disease. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
GPL/CT/2024/002/III; Version 2.0, dated 28-May 2024  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  Dr Rahul Kodgule 
Designation  Sr.GM-Clinical Development Branded Generics 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd Glenmark House, B D Sawant Marg Chakala, Andheri(East) District: Mumbai State: Maharashtra
Clinical Development
Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  912240189999  
Fax    
Email  Rahul.Kodgule@glenmarkpharma.com  
 
Details of Contact Person
Public Query  
Name  Amol Pendse 
Designation  Sr.GM-Clinical Research Operations 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Research Centre, Plot No. A-607, T.T.C. Industrial Area, MIDC, Mahape, Navi Mumbai District: Thane State: Maharashtra

Thane
MAHARASHTRA
400709
India 
Phone  912267720000  
Fax    
Email  Amol.Pendse@glenmarkpharma.com  
 
Source of Monetary or Material Support  
M/s. Glenmark Pharmaceuticals Limited, B2, Mahalaxmi Chambers, 22 Bhula Bhai, Desai Road Mumbai, Maharashtra-400026. 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Ltd 
Address  M/s. Glenmark Pharmaceuticals Limited, B2, Mahalaxmi Chambers, 22 Bhula Bhai, Desai Road Mumbai, Maharashtra-400026 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 18  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrHimanshu Pophale  Ace Hospital & Research Centre  Sr No-32/2A Gulwani Maharaj Road, Erandwane, Pune,Maharashtra, India 411004
Pune
MAHARASHTRA 		 9503939461

himanshupophale@yahoo.co.in 
Dr Srikant Malegaonkar  All India Institute of Medical Sciences(AIIMS) Nagapur  MIHAN, Nagpur, Sumthana, Maharashtra 441108
Nagpur
MAHARASHTRA 		 9582273519

kmsrikant@gmail.com 
DrSandeep Katiyar  Apollo Spectra Hospital (Apollo Speciality Hospital Pvt.Ltd)  14/138, Chunni Ganj, Kanpur-208001
Kanpur Nagar
UTTAR PRADESH 		 9889888080

skkatiyarin@gmail.com 
DrMahavir Bagrecha  Dr.D.Y Patil Medical college, Hospital & Research Centre   Sant Tukaram Nagar Pimpri Pune-411018
Pune
MAHARASHTRA 		 9372630657

bagrechamahavir7@gmail.com 
Drsanjay Khator  Excelcare Hospital  103, Sanjay Nagar-A, Joshi Marg, Kalwar Road, Jhotwara, Jaipur, Rajasthan 302012
Jaipur
RAJASTHAN 		 9314524056

sanjaykhator71@gmail.com 
Dr Mohammad Hafiz Deshmukh  Galaxy Superspeciality Hospital  Agnihotra Chowk, Opp. To Punjab National Bank
Aurangabad
MAHARASHTRA 		 8390628800

drhafizdeshmukhmed@gmail.com 
DrMaheshKumar anandbhai Vaghani  Global Hospital  4th floor,Nr.Navjivan Restaurant,Sarthana Jakat Naka,Surat,Gujarat 395006
Surendranagar
GUJARAT 		 9825433984

maheshavaghani@gmail.com 
DrAnand Kumar  GSVM Medical College  GSVM Medical College, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH 		 917408441501

dranandkumar.research@gmail.com 
DrAshish Nikhare  Lata Mangeshkar Multispeciality Hospital, Nagpur  5,Near YMCA Complex, MaharajBagh Road, Sitabuldi, Nagpur - 440012
Nagpur
MAHARASHTRA 		 8149927258

ashoonikh@gmail.com 
DrRajkumar Gautam Nikalje  Lifepoint Multispecialty Hospital  145/1, Mumbai-Bangalore Highway, Near Hotel Sayaji, Wakad, Pune-411057
Pune
MAHARASHTRA 		 9028560535

rajnikalje80@gmail.com 
DrManish Kumar Jain  Maharaja Agrasen Superspeciality Hospital  Sec -7, Central spine, Vidyadhar Nagar, Jaipur -302039
Jaipur
RAJASTHAN 		 9414414834

doctormanishjain2@gmail.com 
Dr Dinesh kumar Agarwal  Marwari Hospital  Sati Jaymati Road, athgoan, Guwahati Kamrup, Metropolitan Assam-781008
Kamrup
ASSAM 		 9864061456

drdinesh944@gmail.com 
DrP Raghavendra Reddy  Renova Neelima Hospital  Opp.Voltas Company,Sanathnagar, Hyderabad, 500018
Hyderabad
TELANGANA 		 7799992266

drraghavendrareddy.p@gmail.com 
DrVinit Prabhudas Niranjane  Respira Chest & Critical Care Hospital  5th Floor, Plot no.5, Shree radhey Health Heights, Central Bazar Road, Ramdaspeth, Nagpur
Nagpur
MAHARASHTRA 		 919881015523

vinit.niranjane@gmail.com 
DrAkash Lataru balki  Shree Hospital & Critical Care Centre  799,Om Nagar ,Opp.Tajshree Building, Sakkardara Sq, Nagpur-440009
Nagpur
MAHARASHTRA 		 9890812215

akashbalki49@gmail.com 
DrAbhinandan Mutha  Siddhi Hospital  Siddhi Hospital,P-67,MIDC,Satpur,Behind PF office,Trimbak road,Nashik 422007
Nashik
MAHARASHTRA 		 9850767069

abhimutha@gmail.com 
DrKeyur Brahme  SSG Hospital  Department of medicine, Sir Sayajirao general hospital, Medical College Baroda, Jail Road, Indian Avenue, Vadodara
Vadodara
GUJARAT 		 9727729105

keyurbrahme@gmail.com 
DrPravin Dinkar Supe  Supe Heart and Diabetes Hospital & Research Centre  Opp. Adhar Asharam , Near Rungta
Nashik
MAHARASHTRA 		 9028639654

pravinsupe@ymail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 18  
Name of Committee  Approval Status 
Apollo Specialty Hospital Kanpur Ethics Committee  Approved 
ECRC-HEC   Approved 
Ethics Committee Dr. D. Y. Patil Vidyapeeth   Approved 
Ethics Committee GSVM Medical College  Approved 
Ethics committee of Ishwar Institute of Healthcare  Approved 
Global ethics Committee  Approved 
IEC, Maharaja Agrasen Hospital.   Approved 
Institutional Ethica Committee,Neelima Hospital Private ltd   Approved 
Institutional Ethics Committee –ACE Hospital   Approved 
Institutional ethics committee for human research  Approved 
Institutional Ethics Committee Sardarmal Khandaka Memorial Hospital,  Approved 
Institutional ethics committee,AIIMS,Nagpur  Approved 
Institutional Ethics Committee.NKP Salve Institute of Medical Sciences and Research Centre  Approved 
Lifepoint Research Ethics Committee  Approved 
Respira Institutional Ethics Committee   Approved 
Shree Hospital Ethics Committee  Approved 
Siddhi Hospital Institutional Ethics Committee  Approved 
Supe Hospital 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 
Comparator Agent  Formoterol Fumarate Dihydrate 5 µg, Glycopyrronium 7.2 µg and Budesonide 160 µg pressured inhalation suspension  Dosage Form: Pressurized metered dose inhaler Dose: One Inhalation contains Formoterol Fumarate Dihydrate 5 µg, Glycopyrronium 7.2 µg and Budesonide 160 µg Dosage Frequency: Inhalation of 2 actuations twice daily Mode of Administration: Oral Inhalation  
Intervention  Glycopyrronium 25 µg, Formoterol Fumarate 20 µg, Budesonide 500 µg Inhalation Suspension  Dosage Form: Inhalation Suspension for Nebulization Dose: 1 smartule of 2 mL contains Glycopyrronium 25 µg, Formoterol Fumarate 20 µg and Budesonide 500 µg Dosage Frequency: 1 smartule twice daily Mode of Administration: Oral Inhalation using Nebulizer  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Consent: Provide written informed consent and willing to comply with all aspects of the protocol
2. Risk Factor history
a. Tobacco smoke: Current or previous cigarette/beedi smokers with a history of cigarette/beedi smoking of at least 10 pack-years.
Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Screening Visit.
b. Others: Chronic exposure to smoke including biomass fuel smoke.
3. COPD: Diagnosis of COPD (as defined by the GOLD, 2024)
4. Ability to use drug-device: Ability to use nebulized medication independently & correctly in view of the investigator. 
 
ExclusionCriteria 
Details  1. A current or historic diagnosis of asthma.
2. Treatment with triple therapy, i.e. long-acting muscarinic agonist (LAMA), long-acting beta-agonist (LABA) and inhaled corticosteroids (ICS) in one or multiple inhalers, within 1 month before screening.
3. Known respiratory disorders other than COPD including but not limited to alpha-1 antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, history of allergic rhinitis or atopy, pulmonary hypertension, pneumothorax in last 6 months and interstitial lung disease.
4. Any previous lung resection surgery (e.g., lung volume reduction surgery or lobectomy).
5. Chest X-ray or CT scan, which reveals evidence of clinically significant abnormalities, not believed to be due to the presence of COPD (e.g., evidence of pneumonia, other infection, atelectasis, or pneumothorax).
6. Type I or uncontrolled Type II diabetes.
7. History of narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate-to-severe renal impairment or urinary retention (Subjects with a transurethral resection of prostate, subjects who have undergone full re-section of the prostate and, subjects who are asymptomatic and stable on pharmacological treatment for the condition will be considered for the study).
Has a clinically significant laboratory abnormality or a clinically significant condition, in the judgment of the investigator.
8. An abnormal and clinically significant 12-lead electrocardiogram (ECG) as per investigator’s judgement. For the purposes of this study, an abnormal ECG will be defined as a 12-lead tracing which is interpreted with (but not limited to) any of the following:
a. Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome)
b. Unstable ischemic heart disease
c. Clinically significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia)
d. left ventricular failure (New York Heart Association Class III and IV)
e. A mean QTcF value at screening ≥ 450 msec (for males) / ≥ 470 msec (for females) or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave)
11. History of allergy or hypersensitivity to the study medications or any of the excipients.
12. Additional Medications: Unable to stop the medications required to be washed out prior to screening spirometry as per the Drug Withholding for Screening Spirometry:
13. Pregnant or lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Change from baseline in trough FEV1  Time Point: at week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline in trough FEV1  Time Point: at week 4 and week 8 
Change from baseline in 2-hour post-dose FEV1  Time Point: at week 12 
Rescue medication use averaged  Time Point: Over week 11 and 12 
Change from baseline in trough forced vital capacity (FVC)  Time at week 12 
Change from baseline in modified Medical Research Council (mMRC) score  Time Point: at week 12 
 
Target Sample Size   Total Sample Size="314"
Sample Size from India="314" 
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)   07/11/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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  

This is a randomized, double-blind, double-dummy clinical trial to assess the efficacy and safety of fixed dose combination of Glycopyrronium 25 Âµg, Formoterol Fumarate 20 Âµg, Budesonide 500 Âµg Inhalation Suspension (for nebulization) in comparison with fixed dose combination of Formoterol Fumarate Dihydrate 5 Âµg, Glycopyrronium 7.2 Âµg and Budesonide 160 Âµg pressured inhalation suspension in patients with chronic obstructive pulmonary disease.

The total study duration for each subject is approximately 16 weeks; which consists of screening period up to 7 days, run-in period of 2 weeks followed by 12 weeks’ treatment period.

The primary outcome measures consist of change from baseline in in trough FEV1 at week 12. 
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