Clinical Trial Details (PDF Generation Date :- Sun, 05 Sep 2021 04

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Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 03:29:31 GMT)

CTRI Number CTRI/2016/06/007062 [Registered on: 30/06/2016] - Trial Registered Prospectively Last Modified On 12/04/2018 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma Scientific Title of A Multicenter, Randomized, 52-week, Double-blind, Parallel group, Active Controlled Study to Study Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma Secondary IDs if Any Secondary ID Identifier CQVM149B2302 v03 (clean version) dated Protocol Number 08-Oct-2015 NCT02571777 ClinicalTrials.gov Details of Principal Details of Principal Investigator Investigator or overall Name Murugananthan K Trial Coordinator (multi-center study) Designation Head-Clinical Development Affiliation Novartis Healthcare Private Limited Address Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai. Mumbai MAHARASHTRA 400 018 India Phone 022-24958545 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Murugananthan K Query) Designation Head-Clinical Development Affiliation Novartis Healthcare Private Limited Address Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai. Mumbai MAHARASHTRA 400 018 India Phone 022-24958545 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Murugananthan K Designation Head-Clinical Development Affiliation Novartis Healthcare Private Limited Address Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai. Mumbai MAHARASHTRA 400 018

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India Phone 022-24958545 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Novartis Pharma AG, Basel, Switzerland Primary Sponsor Primary Sponsor Details Name Novartis Healthcare Private Limited Address Medical Department, Sandoz House, Shivsagar Estate, Dr. Annie Besant Road Worli, Mumbai-400018. Type of Sponsor Pharmaceutical industry-Global Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile Colombia Croatia Denmark Estonia Finland France Germany Greece Hungary India Ireland Israel Italy Japan Jordan Latvia Lebanon Lithuania Luxembourg Mexico Netherlands Norway Peru Philippines Poland

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Portugal Romania Russian Federation Slovakia Slovenia South Africa Spain Switzerland Thailand United Arab Emirates United Kingdom Viet Nam Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Ashish Kumar Asthma Bhawan Asthma Bhawan, 9414454196 Department of Respiratory Medicine, [email protected] R-3, Sec-6, Vidyadhar Nagar Jaipur-302039 Jaipur RAJASTHAN Dr Bhagirath Solanki B. J. Medical College Department of 09904025799 and Civil Hospital Medicine, B. J. Medical College & Civil Hospital, [email protected] Asarwa, Ahmedabad- n 380 016, Gujarat, India Ahmadabad GUJARAT Dr Vishwanath Bellad BGS Global Hospital BGS Global Hospital, 080-26255555 BG S Global Hospitals, BGS Health & [email protected] Education City, Dept. of om Clinical Research, 5th Floor #67, Uttarhalli Road, Kengeri, Bangalore, IND, Karnataka, 560060 Bangalore KARNATAKA Dr Ajay Godse Bhakti Vedanta Hospital Bhakti Vedanta Hospital 9022145499 & Research Institute & Research Institute, 5th Floor Research [email protected] Department,Shrishti m Complex, Bhakti Vedanta Swami Marg,Mira Road (East),Thane Maharashtra,401107 Thane MAHARASHTRA Dr Amit Patel CARE INSTITUTE OF Department of Clinical 9824310250 MEDICAL SCIENCES research, Near Shukan (CIMS) Mall, Off Science City amit.patel@cimshospita Road, Sola, l.org Ahmedabad-380060. Ahmadabad

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GUJARAT Dr Sundeep Salvi Chest Research Survey No. 15, Behind 9921211000 Foundation Survey No. 15, Marigold complex, [email protected] Kalyani Nagar, Pune 411014. Pune MAHARASHTRA Dr Christopher Christian Medical Christian Medical 9443306573 Devasahayam Jesudas college college, Department of Pulmonary Medicine, [email protected] P.O.Box - 3, Ida n Scudder Road, Vellore - 632 004. Tamilnadu, India. Vellore TAMIL NADU Dr Babaji Ghewade Datta Meghe Institute of Datta Meghe Institute of 9822342770 Medical Sciences(DU) Medical Sciences(DU), Jawaharlal Medical [email protected] College, Acharya om Vinoba Bhave Rural Hospital, Department of Respiratory Diseases, Sawangi (Meghe), Wardha 442004,Maharashtra India Pune MAHARASHTRA Dr Sushant Meshram Department of Department of 9860990379 Pulmonary medicines Pulmonary medicine, Sasoon general Sasooon General [email protected] Hospital Hospitals, near Pune m railway station, Pune - 411001 Pune MAHARASHTRA Dr Zuber Ahmad Department of T.B and Department of T.B and 9412175925 Respiratory disease, Respiratory disease, J.N. Medical College J.N. Medical College,, [email protected] Aligarh Muslim University, Aligarh, IND, Uttar Pradesh, 202002 Aligarh UTTAR PRADESH Dr Krishna Kumar Eternal Health Care Eternal Health Care 9414414265 Sharma Centre & Research Centre & Research Institute Pvt. Ltd Institute Pvt. [email protected] Ltd.,Department of o.in Clinical Research, Room No. 124, Basement 2, 3A, Jagatpura Road, Near Jawahar Circle, Jaipur – 302020 Jaipur RAJASTHAN Dr Amit Kumar Mandal Fortis Hospital Department of 9779901068

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Pulmonology & Critical care(Medical ICU, dramitkrmandal@yahoo Sector 62, Phase VIII, .co.in Mohali-160062. Ludhiana PUNJAB Dr Raja Dhar Fortis Hospital Fortis Hospital, 9831855512 Pulmonology Department, 730, [email protected] Anandapur, Kolkata-700107, West Bengal,India Kolkata WEST BENGAL Dr Vijil Rahulan Global Health City Global Health City, 91-9445060066 Institute of Pulmonary and Critical Care [email protected] Medicine, No. 439, Cheran Nagar, Perumbakkam, Chenna i-600100.Tamilnadu, India. Chennai TAMIL NADU Dr Tapaswi Krishna Global Hospital Global Hospital good 9490935455 life building, 6th floor,Dept.of Clinical drtapaswikrishna@gmai research, Opp Dwaraka l.com Hotel, 6-1-1070 1-4Hyderabad- Lakdi-k a-pool,Telangana-5000 04, India. Hyderabad ANDHRA PRADESH Dr Suresh Kumar Gattu Government Dept.of Pulmonology, 91-8374358304 Siddharatha Medical Government Siddhartha College Medical College, Ring sureshkumargattu@gm Road, Gunadala, ail.com Vijayawada - 520008, Andhra Pradesh, India. Krishna ANDHRA PRADESH Dr K P Suraj Government Medical Institute of Chest 9447445135 College, Institute of Diseases, Department Chest Diseases of Pulmonary Medicine, [email protected] Government Medical College, Kozhikode - 673008. Kerala, India. Kozhikode KERALA Dr Anand Kumar GSVM Medical college GSVM Medical college 768800021 ,Department of Pulmonology Near dranandkumar.research Rawtpur Crossing, @gmail.com Kanpur - 208005. Kanpur Nagar UTTAR PRADESH Dr Banani Jena IMS & SUM Hospital IMS & SUM Hospital, 9437100485 Department of

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Pulmonary Medicine, [email protected] K-8, Kalinga Nagar, Bhubaneswar-751003, Orissa, India. Khordha ORISSA Dr Manish Shankar Indira Gandhi Institute Indira Gandhi Institute 9931040100 of Medical Sciences of Medical Sciences,Department of [email protected] TB and chest, sheikpura, Bihar, Patna 800 014. Patna BIHAR Dr Ram Kaulgud Karnataka Institute of Karnataka Institute of 9844426887 Medical Sciences Medical Sciences, Department of [email protected] Medicine, Vidyanagar, m Hubli, IND, Karnataka, 580022 Dharwad KARNATAKA Dr Vishak Acharya Kasturba Medical Department of 9448331570 College Hospital Pulmonary Medicine, Attavar, Mangalore [email protected] 575001, India Dakshina Kannada KARNATAKA Dr Kesavan Nair Kerala Institute of Kerala Institute of 0471-3041406 Veerendran Nair Medical Sciences Medical Sciences, Department of Clinical drkesavan.nair@kimsgl Research, Room No: obal.com 815, KIMS North, 8th floor Anayara P.O., Post Box No: 1 Trivandrum - 695 029 Thiruvananthapuram KERALA Dr Siddanathi King George Hospital Department of 9848136704 Narasinga Rao Medicine, King George Hospital,Rajendra [email protected] Prasad Ward, Maharanipeta, Vishakhapatanam, Andhra Pradesh , 530002 Visakhapatnam ANDHRA PRADESH Dr Rangaswamy KR Hospital KR Hospital, 91-9448749643 Department of Medicine, Mysore drrangaswamy1@gmail Medical College and .com Research Institute, Irwin Road, Mysore - 570001, Karnataka. Mysore KARNATAKA Dr Sailal M KVM Hospital KVM Hospital, 0478-2812228 Department of

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Pulmonology P.B. [email protected] No.30 Cherthala - 688524. Kerala, India Alappuzha KERALA Dr Lakshmi Kumari Lalitha Super Clinical Research 91-863-2222866 Specialities Hospital Department Old Pvt. Ltd Building, Kothapet, laxmikumarisomishetty Guntur - 522001. @gmail.com Guntur ANDHRA PRADESH Dr Sanjay Khator Malpani Multispeciality Clinical Research 9314524056 Hospital Department, VKI, Sikar Road, Jaipur -302013. sanjaykhator71@gmail. Jaipur com RAJASTHAN Dr Guruprasad Bhat Manipal Hospitals Manipal Hospitals, 080-25024631 Clinical Research Center (Ground Floor) guruprasad.bhat@mani 98, HAL Airport Road palhospitals.com Bangalore-560017. Karnataka, India. Bangalore KARNATAKA Dr Raja Bhattacharya Medical College & Medical College & 9477305539 Hospital, Kolkata Hospital, Kolkata, Department of Chest rbrbhattacharya@gmail. Medicine,88, College com street,Kolkata-700073 Kolkata WEST BENGAL Dr Ashish Goyal Medipoint Hospitals Medipoint Hospitals 09372433824 Pvt. Ltd. Pvt. Ltd. ,3rd Flor, Research drashishgoyal1111@g Department,241/1, New mail.com D.P.Road, Aundh, Pune 411007, Maharashtra, India Pune MAHARASHTRA Dr Vivek Gupta Meditrina Institute of Meditrina Institute of 9373115548 Medical Science Medical Science, 7th floor 278, Central Bazar [email protected] Road Ramdaspeth, Nagpur - 440010 Nagpur MAHARASHTRA Dr Velkumar Gopal Meenakshi Mission Meenakshi Mission 0452-4263054 Hospital and Research Hospital and Research Centre Centre, Department of [email protected] Pulmonology and Sleep Medicine, Lake Area, Melur Road, Madurai - 625107. Tamilnadu, India. Madurai TAMIL NADU Dr Anil Kishanrao NKP Salve Institute of Department of 9869027857 Sontakke Sciences & Lata Pulmonology, Digdoh

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Mangeshkar Hospital Hills, Hingna Road, dranil777747@rediffmai Nagpur 440019 l.com Nagpur MAHARASHTRA Dr Rajeev Adkar Noble Hospital Pvt Ltd Noble Hospital Pvt Ltd., 8956386968 Fourth Floor, Department of [email protected] Pulmonology, 153, om Magarpatta City Road, Pune- 411013. Pune MAHARASHTRA Dr Ashfaq Hasan Owaisi Hospital and Owaisi Hospital and 9848051708 Research Centre Research Centre, Deccan College of [email protected] Medical Sciences, 1st m floor , Dept.of Pulmonary medicine, Kanchanbagh, Hyderabad - 500058 Hyderabad ANDHRA PRADESH Dr Arunesh Kumar Paras Hospital Paras 8340389940 Hospital,Department of Pulmonology, Block draruneshkumar@yaho C-1, Sushant Lok o.co.uk Phase I,Sector 43, Gurgaon, INDIA, Haryana, 122 002 Gurgaon HARYANA Dr Mohan Kotnur Rao RajaRajeshwari Department of TB and 9845270973 Medical College and Chest Diseases, Hospital Kambipura, Mysore [email protected] Road, Bangalore - 560074 Bangalore KARNATAKA Dr Janak Bhavsar SAL Hospital, SAL Hospital, 812, 8th 9825162571 Floor, Clinical Research Department,Near janakbhavsar@hotmail. Doordarshan Tower, com Thaltej, Ahmedabad,380052 Ahmadabad GUJARAT Dr Jagdish Kumar Shri Guru Rai Institute Shri Mahant Indiresh 9639212630 Rawat of Medical & Health Hospital, Department of Sciences Pulmonary, Patel drjagdishrawat@yahoo. Nagar, com Dehradun-248001. Dehradun UTTARANCHAL Dr Abhinandan Mutha Siddhi Hospital, C/O Mutha Hospital, 9850767069 P-67, M.I.D.C. Satpur, Behind I.T.I., Near P.F. [email protected] Office, Trimbak Road, Nashik MAHARASHTRA

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Dr Ujjwal Parakh Sir Ganga Ram Sir Ganga Ram 9810086865 Hospital Hospital, Department of Research, Room bobbybhalotra1@yahoo No.G8A, Ground .co.in Floor,Sir Ganga Ram Hospital Marg , Rajinder Nagar, New Delhi-110060 New Delhi DELHI Dr Surendra Kumar SP Medical College SP Medical College, SP 9414604192 Medical College Rd, PBM Hospital, drsurendrakumar@redif Department of fmail.com Pulmonary, Bikaner, Rajasthan 334001,India Bikaner RAJASTHAN Dr Hemalatha V S Sree Narayana Institute Sree Narayana Institute 0484-2573023 of Medical Sciences of Medical Sciences, Department of drhemalathavs@gmail. Pulmonary Medicine com Chalakka, N.Kuthiyathod.P.O. Ernakulam - 683594. Kerala, India. Ernakulam KERALA Dr Srikanth Sri Bala Medical Center Sri Bala Medical Center 9894257706 Krishnamurthy & Hospital & Hospital, Department of Pulmonology, 901, [email protected] Trichy Road, om Ramanathapuram, Coi mbatore-641045,Tamil Nadu, India Coimbatore TAMIL NADU Dr Animesh Arya Sri Balaji Action Sri Balaji Action 9810350355 Medical Institute Medical, Institute, Department of dranimesharya@gmail. Respiratory Medicine, com A4 Paschim Vihar, New Delhi 110063 New Delhi DELHI Dr Nagaraju Boyilla St. Theresas Hospital St. Theresas Hospital, 9848883444 Dept of clinical research, PRD block, [email protected] Erragadda, Sanath nag ar,Hyderabad-500018 Telangana, India Hyderabad ANDHRA PRADESH Dr Tushar Patel Sterling Hospital Sterling 9825082672 Hospital,Dept.of Pulmonology,,Sterling [email protected] Hospital Road, om Memnagar Ahmedabad-380052

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Ahmadabad GUJARAT Dr Supraja The Madras Medical The Madras Medical 044-26565974 Kalyanaraman Mission Mission, Department of Clinical Research, 4-A, [email protected] Dr.J. Jayalalitha Nagar, Mogappair, Chennai - 600037. Tamilnadu,India Chennai TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Sri Balaji Action Approved 21/07/2016 No Medical Institute ethics Committee_Dr Animesh Arya Institutional Ethics Approved 30/08/2016 No Commiitee, B J Medical College and Civil Hospital_Dr Bhagirath Solanki Eternal Heart Care Approved 05/03/2016 No Centre & Research Institute – Institutional Ethics Committee_Dr Krishna Kumar Sharma Institutional Ethics Approved 04/03/2016 No Committee Malpani Multispeciality Hospital_Dr Sanjay Khator Institutional Ethics Approved 19/05/2016 No Committee, Government Medical College, Institute of Chest Diseases, Dr K P Suraj Ethics Committee, Approved 04/04/2016 No Asthma Bhawan, Dr Ashish Kumar Malpani Sir Ganga Ram Approved 06/09/2016 No Hospital Ethics Committee,Dr UjjwalParakh Institutional Ethics Approved 09/03/2016 No Committee, Sterling Hospital, Dr Tushar Patel Sri Bala Medical Center Approved 11/08/2016 No & Hospital,Institutional Human Ethics Committee_Dr Srikanth Krishnamurthy Pentamed Ethics Approved 11/04/2016 No Committee_Dr Ashish Goyal

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Ethics Committee, Approved 05/12/2016 No Siddhartha Medical college & Government General hospital, Dr Suresh Kumar Gattu Lalitha Super Approved 18/03/2016 No Specialities Hospital Ethics Committee_Dr Lakshmi Kumari Institutional Ethics Approved 09/08/2016 No committee Mysore Medical College and Research Institute_Dr Rangaswamy Ethics Committee of Approved 25/05/2017 No Manipal Hospitals_Dr Guruprasad Bhat Institutional Ethics Approved 12/12/2016 No Committee - Sree Narayana institute of Medical Sciences_Dr Hemlatha V S Institutional Ethics Approved 05/04/2016 No Committee - KVM Hospital_Dr Sailal M Institutional Ethics Approved 13/07/2016 No Committee - The Madras Medical Mission_Dr Supraja Kalyanaraman Bhakti Vedanta Hospital Approved 30/06/2016 No Ethics Committee_Dr Ajay Godse Ethics Committee, Approved 18/10/2016 No Datta Meghe Institute of Medical Sciences(DU), Dr Babaji Ghewade Manipal University Approved 05/04/2016 No Ethics Committee, Kasturba Hospital, Kasturba Medical College Hospital, Dr Vishak Acharya Noble Hospital Submittted/Under No Date Specified No Institutional Ethics Review Committee, Noble Hospital Pvt. Ltd. _Dr Rajeev Adkar Ethics Committee Approved 25/05/2016 No Silver, Research office Christian Medical College, Dr Christopher Devasahayam Jesudas Ethics Committee - Approved 18/07/2016 No Meenakshi Mission Hospital & Research Centre_Dr Velkumar Gopal

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Institutional Ethics Approved 23/04/2016 No Committee - Global Hospitals & Health City_Dr Vijil Rahulan Institutional Ethics Co Approved 16/01/2017 No mmittee,I.G.I.M.S,Patna -800014._Dr Manish Shankar Institutional Ethics Approved 28/09/2016 No Committee, Paras Hospital, Dr Arunesh Kumar Ethics Committee, S. P. Approved 28/07/2016 No Medical & A.G.Hospital, Dr Surendra Kumar Institutional Ethics Approved 02/08/2016 No Committee, SAL Hospital & Medical Institute_Dr Janak Bhavsar Institutional Ethics Approved 25/03/2017 No Committee, Fortis Hospital, Dr Amit Kumar Mandal Ethics Committee, Approved 28/09/2016 No Bioethical Committee, J N Medical College_Dr Zuber Ahmad Ethics Committee, Approved 06/07/2016 No GSVM Medical College_Dr Anand Kumar Institutional ethics Submittted/Under No Date Specified No committee for human Review research, Medical College & Hospital, Dr Raja Bhattacharya Meditrina Institute Approved 20/05/2016 No Ethics Commitee, Meditrina Institute of Medical Science, Dr Vivek Gupta Institutional Ethics Approved 15/06/2016 No Committee, Raja Rajeshwari Medical College & Hospital, Dr Mohan Kotnur Rao Institutional Ethics Approved 12/07/2016 No Committee, NKP Salve Institute of Sciences & Lata Mangeshkar Hospital, Dr Anil Kishanrao Sontakke Institutional Ethics Approved 02/09/2016 No committee, BJ Medical College & Sassoon General Hospital, Dr Sushant Meshram

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Institutional Ethics Approved 04/07/2016 No Committee, Fortis Hospital, Dr Raja Dhar Ethics Committee, Approved 23/06/2016 No St.Theresas Hospital, Dr Nagaraju B Institutional Ethics Approved 20/08/2016 No Committee, Deccan College and Medical Science and Allied Hospital, Owaisi Hospital and Research Centre, Dr Ashfaq Hasan Institutional Ethics Submittted/Under No Date Specified No Committee, Institute of Review Medical Science IMS & SUM Hospital, Dr Banani Jena Institutional Ethics Approved 16/05/2016 No Committee, Global Hospitals, Dr Tapaswi Krishna Institutional Ethics Approved 19/09/2016 No Committee, Shri Guru Ram Rai Institute of Medical & Health Sciences, Dr Jagdish Rawat Institutional Ethics Approved 05/07/2016 No Commiittee, King George Hospital, Dr Siddhanathi Narasinga Rao Institutional Ethics Approved 15/07/2016 No Commiitee -BGS Global Hospital, Dr Vishwanath Bellad Institutional Human Approved 30/11/2016 No Ethics Commiittee, KIMS, Dr Kesavan Nair Veerendran Nair Institutional Ethics Approved 15/07/2016 No Commiittee, KIMS, Hubli, Dr Ram Kaulgud Siddhi Hospital Approved 09/11/2017 No Institutional Ethics Comittee, Dr Abhinandan Mutha Institutional Ethics Approved 06/10/2017 No Committee, Chest Research Foundation, Dr Sundeep Salvi Institutional Ethics Approved 17/01/2018 No Committee, CARE INSTITUTE OF MEDICAL SCIENCES (CIMS), Dr Amit Patel

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Regulatory Clearance Status Date Status from DCGI Approved/Obtained 21/06/2016 Health Condition / Health Type Condition Problems Studied Patients Asthma Intervention / Type Name Details Comparator Agent Intervention QVM149 150/50/160µg once QVM149 150/50/160 µg Dose daily frequency: Once Daily. Duration: 52 weeks Route of administration: Inhalation, delivered via Concept1 device. Intervention QVM149 150/50/80µg once QVM149 150/50/80 µg Dose daily frequency: Once Daily. Duration: 52 weeks. Route of administration: Inhalation, delivered via Concept1 device. Comparator Agent QMF149 150/160µg once daily QMF149 150/160 µg Dose frequency: Once Daily. Duration: 52 weeks. Route of administration: Inhalation, delivered via Concept1 device. Comparator Agent QMF149 150/320 µg once daily QMF149 150/320 µg Dose frequency: Once Daily. Duration: 52 weeks. Route of administration: Inhalation, delivered via Concept1 device. Comparator Agent Salmeterol xinafoate/ Salmeterol xinafoate/ fluticasone propionate 50/500 fluticasone propionate 50/500 µg, Twice daily µg. Dose frequency: Twice Daily (b.i.d.). Duration: 52 weeks. Route of administration: Inhalation, delivered via delivered via Accuhaler®. Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 75.00 Year(s) Gender Both Details • Patients with a diagnosis of asthma, (GINA 2015 ? step 4) for a period of at least 1 year prior to Visit 1 (Screening).
• Patients who have used ICS/LABA combinations (Appendix 10) for asthma for at least 1 year and at stable medium or high doses of ICS/LABA for at least 1 month prior to Visit 1. Patients must be symptomatic at screening despite treatment with mid or high stable doses of ICS/LABA.
• Patients with ACQ-7 score ? 2 at Visit 1 (or 101 if no wash-out required) and at Visit 102 (randomization visit) (GINA 2015? step 4).
• Patients with documented history of at least one asthma exacerbation which required medical care from a physician, ER visit (or local equivalent structure) or hospitalization in the 12 months prior to Visit 1 and required systemic corticosteroid treatment.
• Pre-bronchodilator FEV1 of < 80 % of the predicted normal value for the patient after withholding bronchodilators at both visits 101 and 102.
• Withholding period of bronchodilators prior to spirometry: SABA for ? 6 hrs, LABA (or FDC of ICS/LABA) for ? 24 hrs (48 hrs for indacaterol FDC), SAMA for ? 8 hrsxanthines ? 7 days.
• Retesting is allowed once only. Re-assessment of percentage predicted FEV1 should be done in an ad-hoc visit to be scheduled on a date that would provide sufficient

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time to receive confirmation from the spirometry data central reviewer of the validity of the assessment before randomization. Spacer devices are not permitted during reversibility testing.
• Patients who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101.All patients must perform a reversibility test at Visit 101. If reversibility is not demonstrated at Visit 101 then one of the following criteria need to be met.
• Reversibility may be repeated once.
• Patients may be permitted to enter the study with historical evidence of reversibility that was performed according to ATS/ERS guidelines within 1 year prior to Visit 1.
• Alternatively, patients may be permitted to enter the study with a historical positive bronchoprovocation test that was performed within 2 years prior to Visit 1. If reversibility is not demonstrated at Visit 101 (or after repeated assessment) and historical evidence of reversibility is not available (or was not performed according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines patients must be screen failed
Exclusion Criteria Exclusion Criteria Details • Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening). If patients experience an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation. • Patients who have ever required intubation for a severe asthma attack/exacerbation. • Patients who have a clinical condition which is likely to be worsened by ICS administration, like glaucoma, cataract and fragility fractures, who are according to Investigator medical opinion at risk participating in the study. • Patients treated with a LAMA for asthma within 12 months prior Visit 1 (Screening). • Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck obstruction or severe renal impairment or urinary retention. BPH patients who are stable on treatment can be considered). • Patients who have had a respiratory tract infection or asthma worsening according to the within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening. • Patients with evidence upon visual inspection (laboratory culture is not required) of clinically significant (in the opinion of investigator) oropharyngeal candidiasis at Visit 102 or earlier, with or without treatment. Patients may be re-screened once their candidiasis has been treated and has resolved. • Patients with any chronic conditions affecting the upper respiratory tract (e.g. chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study. • Patients with a history of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis. • Patients with diabetes Type I diabetes or uncontrolled Type II diabetes. • Patients who, either in the judgment of the investigator or the responsible Novartis personnel, have a clinically significant condition

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such as (but not limited to) unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure arrhythmia, uncontrolled hypertension, cerebrovascular disease, psychiatric disease, neurodegenerative diseases, or other neurological disease, uncontrolled hypo- and hyperthyroidism and other autoimmune diseases, hypokalemia, hyperadrenergic state, or ophthalmologic disorder or patients with a medical condition that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study. • Patients with paroxysmal (e.g., intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blockers, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at the run-in (Visit 101) and end of run-in (Visit 102) visits with a resting ventricular rate • Patients with a history of myocardial infarction within the previous 12 months. • Concomitant use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study • Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (> 450 msec for males and > 460 msec for females) and confirmed by a central assessor (these patients should not be rescreened). • Patients with a history of hypersensitivity to any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof. • Patients who have not achieved an acceptable spirometry result at Visit 101 in accordance with ATS /ERS criteria for acceptability and repeatability (rescreening allowed only once). • Patients unable to use the Concept1 dry powder inhaler, Accuhaler or a metered dose inhaler. Spacer devices are not permitted. History of alcohol or other substance abuse. • Patients with a known history of non-compliance to medication or who were unable or unwilling to complete a patient diary or who are unable or unwilling to use Electronic Peak Flow with e-diary device. • Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers).

Method of Generating Computer generated randomization Random Sequence Method of Centralized Concealment Blinding/Masking Participant, Investigator and Outcome Assessor Blinded Primary Outcome Outcome Timepoints Trough FEV1 26 weeks [ Designated as safety issue: No ] To demonstrate superiority of either QVM149 150/50/80 µg o.d. to QMF149 150/160 µg o.d. or QVM149 150/50/160 µg o.d. to QMF149 150/320 µg o.d on through FEV1 over 26 weeks of treatment. Secondary Outcome Outcome Timepoints •Trough FEV1 at week 52 52 weeks •FVC at week 4 and week 12 12 weeks •PEF over 26 and 52 weeks 52 weeks

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•ACQ-7 52 weeks •% days with no symptoms (overall, at 52 weeks awakening and rising) •% days without rescue medication use over 26 52 weeks and 52 weeks •% patients with MID ACQ greater than or 52 weeks equals to 0,5 at week 26 and 52 •asthma exacerbation over 52 weeks 52 weeks •% rescue medication free days over 26 and 52 52 weeks weeks •AQLQ 52 weeks • Trough FEV1 at 26 weeks comparison with 26 weeks salmeterol xinafoate /fluticasone propionate 50/500 µg via Accuhaler®

• Asthma control as assessed by the Asthma 26 weeks Control Questionnaire (ACQ-7) comparison with salmeterol xinafoate /fluticasone propionate 50/500 µg via Accuhaler® •Serious asthma outcome incidence and CCV 52 weeks events/atrial fibrilaltion •Adverse events, vital signs, laboratory analysis 52 weeks and ECG •FEV1 at week 4 and week 12 12 weeks Target Sample Size Total Sample Size=3155 Sample Size from India=600 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 30/06/2016 Enrollment (India) Date of First 08/12/2015 Enrollment (Global) Estimated Duration of Years=2 Trial Months=4 Days=0 Recruitment Status of Closed to Recruitment of Participants Trial (Global) Recruitment Status of Closed to Recruitment of Participants Trial (India) Publication Details No publication provided

Brief Summary

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1) Purpose of the Trial - The purpose of the trial is to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 ?g and QVM149 150/50/160 ?g via Concept1) over two respective QMF149 doses (QMF 150/160 ?g and QMF 150/320 ?g via Concept1 in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.

2) FPFV from India - 30-Jun-2016

page 18 / 19 PDF of Trial CTRI Website URL - http://ctri.nic.in

3) The target sample for India - 600

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