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CTRI Number  CTRI/2023/01/048645 [Registered on: 02/01/2023] Trial Registered Prospectively
Last Modified On: 09/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy and safety study to assess between two drugs (Inhaler) in patients with Chronic Obstructive Pulmonary Disease 
Scientific Title of Study   Multicenter, Randomized, Open-label, Comparative, Parallel Group study to assess the efficacy and safety of a fixed dose combination of Lupins Glycopyrronium plus Vilanterol dry powder inhaler versus fixed dose combination of Glycopyrronium plus Formoterol dry powder inhaler in patients with Chronic obstructive pulmonary disease  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
LRP/VGDPI/2021/005 Version 1.0 dated 14 Sep 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Neelakant Krishnan 
Designation  Head Clinical Operations 
Affiliation  Lupin Limited 
Address  46A/47A, Nande Village, Mulshi Taluka, Pune-412115, Maharashtra, India

Pune
MAHARASHTRA
412115
India 
Phone  9873715630  
Fax    
Email  neelakantkrishnan@lupin.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hemasundara Rao Dumpala 
Designation  Deputy General Manager- Medical Monitoring and Safety Monitoring 
Affiliation  JSS Medical Research Asia pacific Private Limited 
Address  Tower 2,1st Floor, South Wing, L and T Business,Faridabad,Haryana-121003,India

Faridabad
HARYANA
121003
India 
Phone  8125991858  
Fax    
Email  hemasundara.dumpala@jssresearch.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayashri Krishnan 
Designation  Director-Operations 
Affiliation  JSS Medical Research Asia pacific Private Limited 
Address  Tower 2,1st Floor, South Wing, L and T Business,Faridabad,Haryana-121003,India

Faridabad
HARYANA
121003
India 
Phone  9771407484  
Fax    
Email  Jayashri.krishnan@jssresearch.com  
 
Source of Monetary or Material Support  
Lupin Limited, 46A/47A, Nande Village, Mulshi Taluka, Pune 412115, Maharashtra, India  
 
Primary Sponsor  
Name  Lupin Limited  
Address  46A/47A, Nande Village, Mulshi Taluka,Pune-412115, Maharashtra, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
JSS Medical Research Asia pacific Private Limited  Tower 2,1st Floor, South Wing, L and T Business,Faridabad,Haryana-121003,India 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandeep Katiyar  Apollo Specialty Hospital Pvt. Ltd.  Room No-20, 14/138, Chunni Ganj, Kanpur-208002, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH 		 9889888080

skkatiyarin@gmail.com 
Dr Sandeep Kadian  Asian Institute of Medical Sciences (AIMS)  Ground Floor, Dept. of Pulmonary Medicine, P-72 Milap Nagar,MIDC, Dombivli (E) 421203, Maharashtra, India
Thane
MAHARASHTRA 		 9870364574

drsandeepkadian@rediffmail.com 
Dr Mannem Upendra Kumar  Excel Hospital  Room No: 104, 1-5-56/29, Old Alwal Rd, beside Bharat Petroleum, Near IG Statue, Banda Basti, Old Alwal, Alwal, Secunderabad, Telangana 500010, India
Medchal
TELANGANA 		 9951536522

Upendramd190@gmail.com 
Dr Sanjay Verma  G.S.V.M Medical College  Room No: 11, Ground Floor, Department of Respiratory Medicine, Swaroop Nagar, Kanpur, Uttar Pradesh 208002, India
Kanpur Nagar
UTTAR PRADESH 		 9415075478

drskverma78@rediffmail.com 
Dr Shreehas Bardapurkar  Ishwar Institute of Health Care  Ishwar Heights, 1st floor, plot no-7, gut no 6/1, beside Punjabi bhavan, Padegaon, Aurangabad-431002, Maharashtra, India
Aurangabad
MAHARASHTRA 		 9405912791

sbardapurkar@gmail.com 
Dr Neeraj Gupta  Jawahar Lal Nehru Medical College  Ground Floor, Dept. of Pulmonary Medicine, Kala Bagh, Ajmer- 305001, Rajasthan, India
Ajmer
RAJASTHAN 		 9829101942

drneerajajmer@yahoo.com 
Dr Rajkumar Nikalje  Lifepoint Multispecialty Hospital  Department of Pulmonary Medicine, Ground floor, 145/1, Mumbai-Bangalore Highway, Near Hotel Sayaji, Wakad, Pune-411057, Maharashtra, India
Pune
MAHARASHTRA 		 9730475068

nikaljeraj80@gmail.com 
Dr Manish Kumar Jain  Maharaja Agrasen Superspeciality Hospital  Room No-09, Department of Pulmonary Central Spine, Division-Pulmonology, Agrasen Aspatal Marg Sector 7, Vidyadhar Nagar, Jaipur, Rajasthan – 302039, India
Jaipur
RAJASTHAN 		 9414414834

Doctormanishjain2@gmail.com 
Dr Pawan Kumar Singh  Pt. B. D. Sharma, PGIMS  Room No: 130, 1st Floor. Department of Pulmonary & Critical Care Medicine, Rohtak, Haryana 124001, India
Rohtak
HARYANA 		 8437013094

ga.ps.complete@gmail.com 
Dr Monica Gupta  Samvedna Hospital  Ground Floor, Main Building, B27/88G, New Colony, Ravindrapuri, Varanasi-221005, India.
Varanasi
UTTAR PRADESH 		 9415336322

monica.samvedna@gmail.com 
Dr S N Gupta  Sanjivini Hospital and Research Centre  Ground Floor, CP-23, Virajkhand, Gomti Nagar, Hahneman Chauraha, Lucknow-226010, Uttar Pradesh, India
Lucknow
UTTAR PRADESH 		 8415007110

smsdgupta@gmail.com 
Dr Deepak Varade  Shree Ashirwad Hospital  Second Floor, C-3/4, Shree Complex, Opp. Mahavir Nagar, Manpada Road, Dombivli East-421201, Maharashtra, India
Thane
MAHARASHTRA 		 9870409142

Deepak.varade@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Altezza Institutional Ethics Committee Shree Ashirwad Hospital, Dombivli East  Approved 
Ethics Committee GSVM Medical College, Kanpur  Approved 
Ethics committee of Ishwar Institute of Health Care, Aurangabad  Approved 
Excel Hospital Institutional Ethics Committee, Secunderabad, Telangana  Approved 
Institutional Ethics Committee, Jawahar Lal Nehru Medical College, Ajmer  Approved 
Institutional Ethics Committee, Apollo Specialty Hospital Pvt. Ltd, Kanpur  Approved 
Institutional Ethics Committee, Pt. B.D. Sharma, PGIMS/UHS, Rohtak  Approved 
Institutional Ethics Committee- Maharaja Agrasen Superspeciality Hospital, Jaipur  Approved 
Lifepoint Research-Ethics Committee, Pune  Approved 
Samvedna Hospital Ethics Committee,Varanasi  Approved 
Sanjivini Lung Centre Ethics Committee, Lucknow  Approved 
Suraksha Ethics Committee Asian Institute of Medical Sciences, Dombivli (E)  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  AIRZ-25F  Glycopyrronium 25 μg plus Formoterol 12 μg + DPI for Twice a day Inhalation Treatment Period:12 Weeks  
Intervention  Glycopyrronium 50 μg plus Vilanterol 25 μg DPI  Glycopyrronium 50 μg plus Vilanterol 25 μg DPI for Once a day Inhalation Treatment Period:12 Weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Male or female patients, aged ≥18 to ≤ 75 years at screening
2. Patients with a diagnosis of COPD (as defined by the GOLD Guidelines, 2021)
3. Post-bronchodilator FEV1 ≥30% and <80% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) ratio < 0.70
4. A modified Medical Research Council dyspnoea scale (mMRC) grade 2 or greater.
5. COPD treatment stable dose of maintenance monotherapy (LAMA, LABA or ICS), or stable dose of double maintenance therapy (LAMA/LABA or ICS/LABA), for one month prior to screening
6. 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.)
 
 
ExclusionCriteria 
Details  Subjects who will not meet any of the following criteria will be included in the trial:
1. Patients who are currently receiving dual drug treatment with LABA+LAMA
2. Known respiratory disorders other than COPD including, but not limited to the following: tuberculosis, alpha-1 antitrypsin deficiency, cystic fibrosis, asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease
3. 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 infarction, arrhythmia, long QT syndrome, atrial fibrillation), renal, neurological, endocrine, immunological, psychiatric, hepatic, or hematological disease or abnormality which, in the opinion of the investigator, are clinically significant and would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbates during the study
4. No 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 is no chest X-ray/CT scan is taken within six months prior to screening, a chest X-ray will be performed during screening to rule out any other significant abnormality.
5. History of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction, or severe renal impairment or urinary retention or any other condition, which, in the opinion of the investigator, would contraindicate the use of an anticholinergic or long-acting beta-agonist agent
6. History of allergy or hypersensitivity to any of the ingredients of study drugs or components of the delivery system
7. Suspected or confirmed SARS-COV2 infection at screening (prior to randomization the subjects will be tested for COVID 19 through rapid antigen test).
8.Hospitalization for COPD exacerbation or pneumonia within three months prior to screening. Any subject who experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded.
9. Clinically significant abnormal electrocardiogram (ECG) finding at screening.
10. Lung volume reduction surgery within 12 months prior to the initiation of the study.
11. Requirement of long term (> 12 hours daily) oxygen therapy
12. Unable to stop the following medications at the defined times prior to screening spirometry:

Medication Required washout period prior to screening spirometry
Ipratropium or ipratropium/salbutamol 8 Hrs
combination product
Inhaled short acting β-agonists 6 hours
Oral β 2-agonists 48 hours
Long acting β-agonists
(salmeterol and formoterol)
or ICS/LABA combination products 48 hours
Xanthines 48 hours
Cromolyn and nedocromil inhalers 24 hours
Zafirlukast, montelukast, zileuton 48 hours
Long-acting anticholinergics
(Tiotropium etc.) 48 hours
Oral or parenteral corticosteroids 6 weeks
Any other investigational medication 30 days or 5 half-lives of the
investigational drug (whichever is longer)
Depot corticosteroids 3 months

Inhaled corticosteroids (ICS) Washout not required

13.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 was longer preceding informed consent or scheduled to participate in another clinical study involving an IP.

Additional exclusion criteria for Run-In period:
COPD exacerbation requiring treatment with antibiotics, systemic corticosteroids (oral or intravenous), and/or a hospitalization during screening and run-in period


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
•Change from baseline in trough FEV1   week 12 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change from baseline in trough FEV1
2. Change from baseline in 2 h post-dose FEV1
3.Use of rescue medication averaged over treatment period
4.Frequency of exacerbations (COPD exacerbation requiring treatment with antibiotics, systemic corticosteroids (oral or intravenous), and/or a hospitalization) during the treatment period 		 1.week 4 and week 8
2.week 12
3.12 weeks
4.12 weeks 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   02/01/2023 
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="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

A Multi-center, Randomized, Open-label, Comparative, Parallel Group study to assess the efficacy and safety of a fixed dose combination of Lupin’s Glycopyrronium + Vilanterol dry powder inhaler versus fixed dose combination of Glycopyrronium + Formoterol dry powder inhaler in patients with Chronic obstructive pulmonary disease.

 

Approximately 14 weeks

 

Screening up to 10 days {including run-in period of atleast 7 days}

 

Treatment period: 12 weeks]

 
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