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CTRI Number  CTRI/2023/10/058791 [Registered on: 18/10/2023] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate the efficacy and safety of Fixed Dose Combination of Glycopyrronium, Formoterol Fumarate, Budesonide in patients with chronic obstructive pulmonary disease. 
Scientific Title of Study   A prospective, single-arm, open-label, multicentre, phase IV clinical trial to assess the efficacy and safety of Fixed Dose Combination of Glycopyrronium, Formoterol Fumarate, Budesonide dry powder for inhalation (DPI) in patients with Chronic Obstructive Pulmonary Disease 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
CRNI/CTP/014 CRNI/CTP/014 Version 1.0 dated 07 Apr 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr RV Lokesh Kumar 
Designation  General Manager Medical Services 
Affiliation  Lupin Limited  
Address  3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz East, Mumbai 400055 India

Mumbai
MAHARASHTRA
400055
India 
Phone  7045664876  
Fax    
Email  rvlokeshkumar@lupin.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nidhi Singh 
Designation  Head Clinical Research  
Affiliation  Clinical Research Network India 
Address  B-806-807, Advant Navis Business Park, Plot#7, Noida-Greater Noida Expressway, Sector 142, Gautam Buddha Nagar UTTAR PRADESH 201305 INDIA
B-806,807, Advant Navis Business Park #Plot #7, Noida-Greater Noida Expressway Sector 142, Noida, Delhi, Noida, Uttar Pradesh 201305
Gautam Buddha Nagar
UTTAR PRADESH
201305
India 
Phone  07906261455  
Fax    
Email  nidhisingh@crnindia.org  
 
Details of Contact Person
Public Query  
Name  Dr Nidhi Singh 
Designation  Head Clinical Research  
Affiliation  Clinical Research Network India 
Address  B-806-807, Advant Navis Business Park, Plot#7, Noida-Greater Noida Expressway, Sector 142, Gautam Buddha Nagar UTTAR PRADESH 201305 INDIA
B-806,807, Advant Navis Business Park #Plot #7, Noida-Greater Noida Expressway Sector 142, Noida, Delhi, Noida, Uttar Pradesh 201305
Gautam Buddha Nagar
UTTAR PRADESH
201305
India 
Phone  07906261455  
Fax    
Email  nidhisingh@crnindia.org  
 
Source of Monetary or Material Support  
Lupin Limited 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz East, Mumbai 400055 India  
 
Primary Sponsor  
Name  Lupin Limited 
Address  3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz East, Mumbai 400055 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jitendra Singh Kushwaha   Prakhar Hospital Pvt Ltd   Dept. Of General Medicine, Prakhar Hospital Pvt Ltd, 8/219 Arya Nagar, Kanpur, Uttar Pradesh- 208002
Kanpur Nagar
UTTAR PRADESH 		 9634660312

dr.jskushwahacr@gmail.com 
Dr Vijaykumar Bhagwan Barge   RCSM ,Medical College and Chhatrapati Pramila Raje General Hospital  Dept. Of Medicine, RCSM,Dasara Chowk, Town Hall, Bhausingji Road, Kolhapur-416002, Maharashtra
Kolhapur
MAHARASHTRA 		 7969792775

drvijaybarge12@gmail.com 
Dr Chintan B Patel   Aatman Hospital  Dept. Of General Medicine, Aatman Hospital,5, Anveshan Row House, Bopal Gam BRTS, Bopal-Ghuma Road, Bopal, Ahmedabad-380058, Gujarat
Ahmadabad
GUJARAT 		 9825182251

cr.aatman@gmail.com 
Dr Deependra Kumar Rai  All India Institute of Medical Sciences  Dept. of General Medicine, AIIMS, Patna, Phulwari sharif, Patna Bihar- 801507
Patna
BIHAR 		 7500411360

drdeependrakumarrai@gmail.com 
Dr Amit S Bhate   Jeevan Rekha Hospital  Dept. of General Medicine, Jeevan Rekha Hospital Dr. B R Ambedkar Road, Belagavi, Karnataka- 590010
Belgaum
KARNATAKA 		 9667177125

dr.amitsureshbhate@gmail.com 
Dr Sarat Kumar Behera  Kanungo Institute of Diabetes Specialties.  Dept. Of TB & Chest, Plot no. 1120-Dumduma, Bhubaneswar-751019
Cuttack
ORISSA 		 9438554039

drsarat2010@rediffmail.com 
Dr Adesh Kumar  Uttar Pradesh University of Medical sciences  A-102, Type-5 Old Campus, UP University of Medical Sciences Saifai, Etawah, Uttar Pradesh 206130
Etawah
UTTAR PRADESH 		 9045473801

dradeshkumar1974@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Institute Ethics Committee All India Institute of Medical Sciences   Approved 
Institutional Ethics Committee (IEC), Prakhar Hospital Pvt Ltd.  Approved 
Institutional Ethics Committee Jeevan Rekha Hospital & Dr. B.R. Ambedkar Road Opp. Civil Hospital  Approved 
Institutional Ethics Committee Uttar Pradesh University of Medical Sciences  Approved 
Institutional Ethics Committee, Aatman Hospital  Approved 
KIDS Ethics Committee, KIDS Hospital  Approved 
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital, Kolhapur Institutional Ethics Committee 2   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  Budamate-G  Fixed Dose Combination of Glycopyrronium (25mcg), Formoterol Fumarate (12mcg), Budesonide (400mcg) dry powder for inhalation in hard gelatine capsule of Lupin Limited. One capsule of study drug twice daily using inhaler device.  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients of either sex between 40-65 years of age (both inclusive).
2. Patients who are current/ex-smokers.
3. Patients diagnosed with moderate to severe COPD as per the GOLD guidelines classification at screening visit:
• Post-bronchodilator FEV1/FVC ratio < 0.7
• Post-bronchodilator FEV1, ≥ 30% to < 80% predicted
4. COPD Assessment Test (CATTM) score ≥ 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 4 weeks at the time of screening.
5. Written informed consent from the patient.
6. Patients literate enough to fill the diary card and willing to comply with the protocol requirements 
 
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 α1 antitrypsin deficiency
3. Patients diagnosed with COVID-19 in last 3 months
4. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
5. Patients 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. Patients who required long-term oxygen therapy (≥12 hours/day) within 4 weeks prior to the screening or during the screening period
8. Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention
9. Patients with known hypersensitivity to formoterol glycopyrronium, salbutamol, other beta-2 agonists or other antimuscarinic agents
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 ≥ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine ≥ 2.5 mg/dl) at screening
12. Patients with continuing history of alcohol and/or drug abuse
13. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
14. Participation in another clinical trial in the past 3 months
15. Any other reason for which the investigator feels that the patient should not participate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in trough FEV1   At 4 weeks & 12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in trough FVC
2.Change in post-bronchodilator FEV1 & FVC
3.Change in CAT score
4.Responder rate
5.Proportion of patients with COPD exacerbations during the study.
6.Rescue bronchodilator use during treatment period.
 		 At 4 weeks, 8 weeks & 12 weeks  
Safety endpoints
• Adverse events reported during the study
• Serious adverse events reported during the study
 		 At 4 weeks, 8 weeks & 12 weeks  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   30/10/2023 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 will be prospective, single-arm, open-label, multicentre, phase IV clinical trial to assess the efficacy and safety of Fixed Dose Combination of Glycopyrronium, Formoterol Fumarate & Budesonide dry powder for inhalation (DPI) in patients with Chronic Obstructive Pulmonary Disease aged 40 to 65 years in India. The study will enroll approximately 200 subjects to receive study drug. Study treatment duration would be 12 weeks and there will be 5 visits. 
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