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CTRI Number  CTRI/2017/08/009286 [Registered on: 08/08/2017] Trial Registered Prospectively
Last Modified On: 18/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A 12-week study to determine efficacy and safety of Glycopyrronium Formoterol combination through dry powder inhaler in patients with Chronic Obstructive Pulmonary Disease 
Scientific Title of Study   A randomized, prospective, open label, comparative, parallel group, multicentre 12 weeks study to evaluate efficacy, safety and tolerability of Glycopyrronium/Formoterol FDC 25mcg/12mcg twice daily in comparison with Glycopyrronium 50mcg once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CP/11/15, Version No. 2 dated 15/09/2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jaideep Gogtay 
Designation  Chief Medical Officer 
Affiliation  Cipla Ltd 
Address  Cipla Ltd.,Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai

Mumbai
MAHARASHTRA
400013
India 
Phone    
Fax    
Email  jgogtay@cipla.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jaideep Gogtay 
Designation  Chief Medical Officer 
Affiliation  Cipla Ltd 
Address  Cipla Ltd.,Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai

Mumbai
MAHARASHTRA
400013
India 
Phone    
Fax    
Email  jgogtay@cipla.com  
 
Details of Contact Person
Public Query  
Name  Mr Abhijit Vaidya 
Designation  Project Manager 
Affiliation  Cipla Ltd 
Address  Cipla Ltd.,Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai

Mumbai
MAHARASHTRA
400013
India 
Phone    
Fax    
Email  abhijit.vaidya@cipla.com  
 
Source of Monetary or Material Support  
Cipla Ltd., Peninsula Business Park, Ganapatrao Kadam Marg, Lower Parel West, Mumbai, Maharashtra 400013 
 
Primary Sponsor  
Name  Cipla Ltd 
Address  Cipla Ltd.,Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai MAHARASHTRA,400013,India  
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 = 33  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pophale Himanshu Shashikant   AMAI Charitable Trust’s Ace Hospital and Research Centre  Department of Pulmonology, S No- 32/2A, Erandwana, Gulwani Maharaj Road, Near Hotel Abhishek, Pune, Maharashtra - 411004
Pune
MAHARASHTRA 		 9503939461

himanshupophale@yahoo.co.in 
Dr Vipul Khandelwal  Apex Hospital Private Limited  SP 4 and 6 Malviya Industrial Area Malviya Nagar Jaipur 302017 Rajashthan
Jaipur
RAJASTHAN 		 9829193517

dr.vipul@yahoo.co.in 
Dr Deshpande Shrikant Vishnu   Ashirwad Hospital & Research Center  Maratha Section Next to Jijamata Udyan Ulhasnagar421004 Maharashtra
Thane
MAHARASHTRA 		 9822017445
02512587943
writetoshrikant@gmail.com 
Dr Sandeep K Kadian   Asian Institute of Medical Sciences  P-65 Milap Nagar MIDC Dombivali East Maharashtra India
Thane
MAHARASHTRA 		 9870364574
0251257003
drsandeepkadian@rediffmail.com 
Dr Sharad Tikkiwal  Asthma Bhawan   Department of Pulmonology, R-3, Sector 6, Vidhyadhar Nagar, Jaipur 302039,Rajasthan, India
Jaipur
RAJASTHAN 		 9828027022

sharadtikkiwal@gmail.com 
Dr Swami Shivani   Bansal Hospital and Research Center  Bansal Hospital, 04 Janakpuri 1st Imli Phatak Jaipur 302005 Rajasthan India
Jaipur
RAJASTHAN 		 9990866602
01412595832
drshivaniswami@gmail.com 
Dr Sundeep Salvi  Chest Research Foundation  Department of Pulmonology, Survey No. 15, Marigold Premises, Kalyani Nagar, Vadgaonsheri, Pune - 411 014, Maharashtra, India
Pune
MAHARASHTRA 		 9921211000

ssalvi@crfindia.com 
Dr Naik Bhukya Bhanu  Department of Pulmonary Medicine, Govt. Siddhartha Medical college  Govt. Siddhartha Medical college; Department of Pulmonary Medicine, Ring road, Gunadala, Vijayawada,520008, Andhra Pradesh, India
Krishna
ANDHRA PRADESH 		 09912341474

bhanu_dr2001@yahoo.com.co.in 
Dr Venkatesh Deshpande  Dr Hedgewar Hospital   Department of Pulmonology, Garkheda, Aurangabad, Maharashtra 431005. India
Aurangabad
MAHARASHTRA 		 9881736365

Venkeypande72@gmail.com 
Dr Anand Kumar   Dr. Murarilal Chest Hospital  Department of Pulmonology, Near Rawatpura Crossing, G.S.V.M Medical College, Swaroop Nagar,Kanpur, Uttar Pradesh- 208002, India
Kanpur Nagar
UTTAR PRADESH 		 7860965384

dranandkumar.research@gmail.com 
Dr Raja Dhar   Fortis Hospital  Department of Pulmonology, 730 Anandapur, E.M. Bypass Road, Kolkata-700107, West Bengal, India
Kolkata
WEST BENGAL 		 9831855512

docaardee@yahoo.com 
Dr Anand Patel   Gujarat Medical Education and Research Society (GMERS) Medical College  Department of Pulmonology, Gotri Main Road, Gotri, Vadodara 390021, Gujarat, India
Vadodara
GUJARAT 		 9879771079

dranandkpatel@gmail.com 
Dr Santhosh Kumar PV  Institute of Chest Diseases  Department of Pulmonary Medicine, Government Medical College, Kozhikode, Kerala 673008.India.
Kozhikode
KERALA 		 9847105779

drpvsk@rediffmail.com 
Dr Ritabrata Mitra  Institute of Post graduate Medical Education and Research   Department of Pulmonary Medicine, 244 Acharya J.C Bose Road Kolkata-700020 India
Kolkata
WEST BENGAL 		 9433092364

dr.R.mitra.chest@gmail.com 
Dr Ravindra Reddy Etikala  Kamineni Hospitals Private Limited  Department of Pulmonology, L. B. Nagar, Hyderabad, 500068,Telangana State, India
Hyderabad
ANDHRA PRADESH 		 9848023703

rvndrreddy@yahoo.com 
Dr Anand Srivastava  King Georges Medical University  Department of Pulmonology, Shah Mina Road, Chowk, Lucknow, Uttar Pradesh 226003, India
Lucknow
UTTAR PRADESH 		 9451929495

drsrianand@gmail.com 
Dr Jyothi Virupaxi Hattiholi  KLE s Dr Prabhakar Kore Hospital and Medical Research Center  Nehru Nagar Belagavi Karnataka
Belgaum
KARNATAKA 		 9164012011
08312493099
pulmojyoti@gmail.com 
Dr Vineet Kumar Shukla   KRM Hospital and Research Center  3 92 93 Vijayant Khand Gomti Nagar Lucknow UP 226010 india
Kanpur Nagar
UTTAR PRADESH 		 9554540710
05224079157
krmhrclko@gmail.com 
Dr Sandeep Kumar Gupta  M V Hospital and Research Centre  Department of Medicine, 314/30, Mirza Mandi, Chowk, Lucknow-226003, UP, India
Lucknow
UTTAR PRADESH 		 9336077839

sandeepkumar.gupta@rediffmail.com 
Dr Ashish Goyal   Medipoint Hospitals Pvt. Ltd  Department of Pulmonology, No. 241/1, New, D.P. Road Aundh, Pune Maharashtra, 411007. India.
Pune
MAHARASHTRA 		 9657890464

drashishgoyal7777@gmail.com 
Dr B P Singh   Midland Hospital  Department of Pulmonology, B-55 & C-42,Mandir Marg, Mahanagar Extension, Mahanagar Colony, Lucknow, Uttar Pradesh 226006, India.
Lucknow
UTTAR PRADESH 		 9415011669

bps2159@yahoo.com 
Dr Gongati Kruparao Paramjyothi  Nizam’s Institute of Medical sciences  Department of Respiratory Medicine, Specialty Block, Punjagutta,Hyderabad, 500082, Telangana, India
Hyderabad
ANDHRA PRADESH 		 9849439706

drgkparam@gmail.com 
Dr Harsha D S   Omega Hospital  Department of Pulmonology, Mahaveera Circle, Kankanady, Mangaluru, Karnataka 575002, India
Dakshina Kannada
KARNATAKA 		 8971896049

drharshapadre@gmail.com 
Dr Sumit Agrawal   Oyster & Pearl hospital  Department of Pulmonology, 671 – 75, Ganeshkhind Road, Shivaji Nagar, Pune – 411005, India
Mumbai
MAHARASHTRA 		 9592874787

drsumitagrawal@yahoo.com 
Dr Ashutosh N Aggarwal  Post Graduate Institute of Medical Education and Research  Department of Pulmonology, Sector 12, Chandigarh- 160 012, India
Chandigarh
CHANDIGARH 		 9876105648

aggarwal.ashutosh@outlook.com 
Dr Sulaiman Ladhani  Prince Aly Khan Hospital  Department of Pulmonology, Nesbit Road,Aga Hall, Opp. St Marys Church, Mazgaon, Mumbai, Maharashtra 400010, India
Mumbai
MAHARASHTRA 		 9820336674

drsladhani@gmail.com 
Dr Prakash Harishchandra Kurmi  Shivam Hospital  C4 Satyanarayan Society Gor s Kuva Jashodanagar Char Rasta Maninagar E Ahmedabad 380008 Gujarat
Ahmadabad
GUJARAT 		 9825047692
07925835831
dr_prakashkurmi@yahoo.co.in 
Dr Ajit Singh   SMS Medical College and Hospital  Department of Pulmonology, J.L.N. Marg, Near Narayan Singh Circle, Jaipur 302004, Rajasthan,India
Jaipur
RAJASTHAN 		 9829135692

dr.ajeetsingh@yahoo.com 
Dr Srikanth Krishnamurthy  Sri Bala Medical Centre and Hospital  Department of Pulmonology, Sri Bala Medical Centre and Hospital, Room No 115, 312, Trichy Road, ramanathuram Coimbatore, 641045, TN, India
Coimbatore
TAMIL NADU 		 9894257706

drsrikanthcbe@gmail.com 
DrS Balamurugan  Sri Muthukumaran Medical College Hospital & Research Institute  Department of Pulmonology, Chikkarayapuram, Kunrathur Road Near Mangadu, Chennai- 600069, Tamil Nadu, India
Chennai
TAMIL NADU 		 9841090860

dr.s.bala@gmail.com 
Dr Amritlal T Leuva  SSG Hospital  Jail road, Opp. Bharat Petrol Pump, Indira Avenue, Vadodara, Gujarat 390001
Vadodara
GUJARAT 		 9824009006
02652421056
hodtbcd@rediffmail.com 
Dr Nagaraju Boyilla  St. Theresas Hospital   Department of Pulmonology, Erragadda, Sananthnagar, Hyderabad, Telangana 500038, India
Hyderabad
ANDHRA PRADESH 		 9848883444

drnagaraj.b@gmail.com 
Dr Hansraj Alva   Vinaya Hospital and Research Center   Department of Pulmonology, Post Box No. 717, Karangalpady, Mangalore: 575003, Karnataka, India
Dakshina Kannada
KARNATAKA 		 9343562622

hansrajalva2001@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 33  
Name of Committee  Approval Status 
Ashirwad Ethics Committee for Dr S Deshpande  Approved 
Ethics Committee Asthma Bhavan for Dr. Tikkiwal  Approved 
Ethics committee SMS Medical Collage for Dr. Singh   Approved 
Ethics Committee Sri Muthukumaran Medical College Hospital & Research Institute for Dr. Balamurugan S.  Approved 
Ethics Committee St. Theresas Hospital for Dr Boyilla  Approved 
Ethics Committee, Dr. Babasaheb Ambedkar Medical Research Society For Dr. Venkatesh Deshpande  Approved 
Ethics Committee, G.S.V.M Medical College for Dr. Anand Kumar  Approved 
Ethics Committee, Midland Healthcare & Research Centre for Dr. B. P Singh   Approved 
Ethics Committee, Vinaya Hospital for Dr. Alva   Approved 
Institutional Ethics Committee AMAI Cheritable trust AXE Hospital for Dr Himanshu Pophale  Approved 
Institutional Ethics Committee Dr. Sulaiman Ladhani  Approved 
institutional Ethics Committee for Dr Jyothi Virupaxi Hattiholi  Approved 
Institutional Ethics Committee for Dr Sandeep K Kadian  Approved 
Institutional Ethics Committee for Dr Vikas Pilaniya  Approved 
Institutional Ethics Committee for Dr. Salvi  Approved 
Institutional Ethics Committee for Dr. Srivastava  Approved 
Institutional Ethics Committee for Human Research, Dr A.T. Leuva  Approved 
Institutional Ethics Committee for MV Hospital and research center for Dr Sandip Gupta   Approved 
Institutional Ethics Committee Fortis Hospital for Dr. Dhar  Approved 
Institutional Ethics Committee of Bansal Hospital & Reserach Center, Jaipur for Dr. Shivani Swami  Approved 
Institutional Ethics Committee of govt medical College Kozhikode,Kerala for Dr Santosh Kumar PV  Submittted/Under Review 
Institutional Ethics Committee Siddhartha medical college and govt general hospital, VIjaywada for Dr Bhanu Bukya Naik  Approved 
Institutional Ethics Committee, Postgraduate Institute of Medical Education & Research (PGIMER) Chandigarh For Dr Ashutosh Aggarwal  Approved 
Institutional Human Ethics Committee at GMERS Medical College GOTRI for Dr. Patel Anand  Approved 
IPGME & R Research oversight Committee, Kolkata for Dr Ritabrata Mitra  Submittted/Under Review 
Kamineni Institutional Ethics Committee for Dr. Reddy   Approved 
KRM Hospital Ethics Committee for Dr Vineet Kumar Shukla  Approved 
NIMS Institutional Ethics committee for Dr. Paramjyothi  Approved 
O&P Institutional Ethics Committee for Dr. Sumit  Approved 
Omega Ethical Committee for Dr. Harsha D S  Approved 
Penta Med Ethics Committee for Dr. Ashish Goyal  Approved 
Shivam Ethics Committee, Institutional Ethics Committee For De Prakash Kurmi   Approved 
Sri Bala Medical Center and Hospital Institutional Ethics Committee for Dr. K Srikanth  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Glycopyrronium   50mcg orally inhaled once daily for 12 weeks 
Intervention  Glycopyrronium/Formoterol FDC  25mcg/12mcg orally inhaled twice daily for 12 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. A voluntarily given, written, signed, and dated Informed Consent from subject and/or legally acceptable representative.
2. Subjects of either gender and age between 40 and 65 years (both inclusive)
3. Subjects with moderate to severe COPD (GOLD 2015). Subjects should have a documented history of COPD and spirogram within at least the past 6 months
4. Post-bronchodilator FEV1 ≥ 40% and ≤ 80% of the predicted normal value
5. Post bronchodilator FEV1/FVC ratio of <0.7
6. Current or ex-smoker of at least 10 pack years of cigarette/ biddi smoking
7. Subjects having ability to use pMDI and DPI during the course of the study and able to comply with the study protocol
 
 
ExclusionCriteria 
Details  1.Hypersensitivity to Glycopyrronium or Formoterol or Levosalbutamol or Budesonide or Ipratropium or any of its components
2. Subjects with any hospitalization required for exacerbation or any serious condition in the previous 12 weeks
3. Subjects who had more than two exacerbations in past 1 year
4. Use of systemic corticosteroids/antibiotics in prior 6 weeks
5. Subjects requiring oxygen therapy
6. Clinically significant ECG abnormality
7. Absolute Blood eosinophil count >600 cells/c mm of blood.
8. Clinically significant neurologic, cardiovascular, hepatic, renal, endocrine, pulmonary (post-tuberculosis fibrosis, pulmonary fibrotic disease, pulmonary arterial hypertension), hematologic, psychiatric or other medical illness that will interfere with participation in this study
9. History of asthma or any chronic respiratory disease other than COPD.
10. Occupational and non-smoking COPD
11. Life-threatening/unstable respiratory disease, including lower respiratory tract infection, within the previous 4 weeks.
12. History of lung resection of more than one full lobe.
13. Scheduled for in-patient hospitalization, including elective surgery during the trial.
14. Clinically significant laboratory values, as judged by the investigator.
15. History of clinically significant bladder neck obstruction or urinary retention
16. History of uncontrolled glaucoma
17. History of uncontrolled diabetes mellitus
18. Subjects receiving immunotherapy or live vaccine within past 1 year and inactivated vaccine within 1 month from screening visit 1
19. Participation in clinical trial in prior 4 weeks of screening visit 1.
20. Participation in clinical trial of Glycopyrronium alone or in combination within past 3 months of screening visit 1
21. Female who is pregnant or lactating or planning to be pregnant.
22. Woman of childbearing potential who is unwilling to use adequate contraceptive measures unless abstinence is considered adequate in the opinion of the investigator.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean change in pre dose trough FEV1   At 12 weeks of treatment from baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in 1 hour post dose FEV1 and FVC  At 2, 4, 8 and 12 weeks of treatment from baseline 
Mean change in pre dose trough FVC  At 2, 4, 8 and 12 weeks of treatment from baseline 
Mean change in pre dose trough FEV1  At 2, 4, and 8 weeks of treatment from baseline 
Difference in average daily number of pMDI puffs of rescue medication consumed  At 2, 4, 8 and 12 weeks of treatment from baseline 
Mean change in mMRC scale  At 4, 8 and 12 weeks of treatment from baseline 
Mean change in CAT score  At 4, 8 and 12 weeks of treatment from baseline 
Mean change in COPD and Asthma Sleep Impact Scale (CASIS) score  At 4, 8 and 12 weeks of treatment from baseline 
 
Target Sample Size   Total Sample Size="360"
Sample Size from India="360" 
Final Enrollment numbers achieved (Total)= "356"
Final Enrollment numbers achieved (India)="356" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/08/2017 
Date of Study Completion (India) 30/10/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   "None yet" 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is randomized, prospective, open label, comparative, parallel group, multicentre, phase III study to evaluate efficacy, safety and tolerability of Glycopyrronium/Formoterol FDC 25mcg/12mcg twice daily compared with Glycopyrronium 50mcg once daily. 360 subjects of moderate to severe COPD will be randomized considering 30% dropout and will be receive either Glycopyrronium/Formoterol FDC or Glycopyrronium treatment for 12 weeks.

Primary outcome is Mean change in pre-dose trough FEV1 at 12 weeks of treatment from baseline.  
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