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1 Clinical Trial Details (PDF Generation Date :- Fri, 07 Sep :05:59 GMT) CTRI Number Last Modified On 29/05/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2016/06/ [Registered on: 30/06/2016] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Multiple Arm Trial A clinical trial study conducted across multiple centres to assess the Efficacy and Safety of QMF149 versus Mometasone Furoate in Asthmatic Patients. A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) CQVM149B2301, Version 02 (clean) dated 01-Oct-2015 NCT Name Designation Affiliation Address Protocol Number ClinicalTrials.gov Details of Principal Investigator Murugananthan K Head-Clinical Development Phone Fax Name Designation Affiliation Address Novartis Healthcare Private Limited Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli. Mumbai India murugananthan.k@novartis.com Details Contact Person (Scientific Query) Murugananthan K Head-Clinical Development Novartis Healthcare Private Limited Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli. Details Contact Person (Public Query) India Phone Fax Name Designation Affiliation Address murugananthan.k@novartis.com Details Contact Person (Public Query) Murugananthan K Head-Clinical Development Novartis Healthcare Private Limited Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli. page 1 / 11

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study India Phone Fax > Novartis Pharma AG, Basel, Switzerland. Name Address Type of Sponsor Name NIL List of Countries Argentina Bulgaria China Czech Republic Egypt Germany Guatemala Hungary India Ireland Japan Mexico Poland Republic of Korea Romania Russian Federation Slovakia South Africa United Kingdom Name of Principal Investigator Dr Anant Mohan Dr Sanjay Tripathi Source of Monetary or Material Support Primary Sponsor Details Novartis Healthcare Private Limited Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai Pharmaceutical industry-global Address NIL Name of Site Site Address Phone/Fax/ All India Institue of Medical Sciences (AIIMS) AMC MET Medical College & Sheth L G General Pulmonary Medicine and sleep disorder, Room no. 3098, 3rd floor, teaching block, Ansari Nagar, New Delhi New Delhi DELHI Research Room, Near Medicine Department OPD, Rambag, Maninagar, anantmohan@yahoo.co m krutesh05@yahoo.co.in page 2 / 11

3 Ahmedabad Ahmadabad GUJARAT Dr Virendra Singh Asthma Bhawan Research Division, R-3, Sec-6, Vidyadhar Nagar Jaipur Jaipur RAJASTHAN Dr Rajesh Solanki Dr Krishna Kumar Sharma B J Medical College and Civil Eternal Health Care Centre & Research Institute Pvt. Ltd. Pulmonary Medicine, State TB Training & Demonstration Centre, Civil Campus, Asarwa, Ahmedabad Ahmadabad GUJARAT Clinical Research, Room No. 124, Basement 2, 3A, Jagatpura Road, Near Jawahar Circle, Jaipur Jaipur RAJASTHAN Dr Amit Kumar Mandal Fortis Pulmonology & Critical care(medical ICU), Sector 62,Phase VIII, Mohali Rupnagar PUNJAB Dr Anand Patel Dr KP Suraj GMERS Medical College & General Institute of Chest Diseases, Government Medical College Respiratory Medicine, Old TB, Gotri Road Vadodara Vadodara GUJARAT Pulmonary Medicine, Kozhikode Kozhikode KERALA Dr Zuber Ahmad JLN Medical College T.B and Respiratory disease, Aligarh Muslim University Campus, Aligarh Aligarh UTTAR PRADESH Dr Santosh Kumar King Georges Medical University Pulmonary Medicine, Ground Floor, Chowk, Lucknow Lucknow UTTAR PRADESH Dr Ranjith V KR Medicine, Mysore drsolanki2001@yahoo. co.in dr_kksharma@yahoo.c o.in dramitkrmandal@yahoo.co.in dranandkpatel@gmail.c om drsurajkp@yahoo.com zrin_amu@yahoo.com skumarchest@yahoo.c om page 3 / 11

4 Dr Ashish Nikhare Dr Bharat Gopal Dr Sanjay Khator Dr Raja Bhattacharya Lata Mangeskar Multi Speciality Maharaja Agrasen Malpani Multispeciality Medical College & Medical College and Research Institute, Irwin Road, Mysore Mysore KARNATAKA ranjithvmmcri@gmail.co m Pulmonology department, 5, YMCA complex, Maharajbagh ashoonikh@gmail.com Road, Sitabuldi, Nagpur Nagpur Respiratory and Sleep Medicine, West Punjabi Bagh, New Delhi New Delhi DELHI drbgee@gmail.com Clinical Research Department, Basement, SP-6, Road No-1, V.K.I. sanjaykhator71@gmail. Area, Sikar Road, com Jaipur Jaipur RAJASTHAN Medicine, 4th Floor, MCH building,88, College Street, Kolkata Kolkata WEST BENGAL Dr B Chaitanya Mediciti s Pulmonary Medicine, Sarovar Complex, , Secretariat Road, Hyderabad Hyderabad ANDHRA PRADESH Dr Ashish Goyal Dr Vivek Gupta Dr Balkrushna Tayade Medipoint s Pvt. Ltd. Meditrina Institute of Medical Science NKP Salve Institute of Sciences & Lata Mangeshkar rbrbhattacharya@gmail. com battuchithanya@gmail.c om Medipoint s, Pvt. Ltd.,3rd Floor, Research drashishgoyal1111@g Department,241/1, New mail.com D.P.Road, Aundh, Pune Pune 7th floor, Central Bazar Road Ramdaspeth, Nagpur Nagpur Pulmonology, New building, 3rd floor, Digdoh Hills, Hingna Road, Nagpur vivekurvashi@yahoo.co.in botayade123@gmail.co m page 4 / 11

5 Details of Ethics Committee Dr Yogesh Sharma Dr Manish Kumar Jain Dr Gautam Moharil Dr Bobby Bhalotra Dr Venkata Nagarjuna Maturu Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj S. R. Kalla Memorial Gastro & General Shrikrishna Hrudayalaya and Critical Care centre Sir Ganga Ram Yashoda Nagpur Medicine, Thane-Belapur Road, Kalwa, Thane Thane Clinical Research Department, 3rd Floor, 78-79, Dhuleshwar Garden, Behind HSBC Bank, Saradar Patel Marg, C-Scheme, Jaipur Jaipur RAJASTHAN Research room at basement, Tikekar Road, Congress Nagar Square, Dhantoli, Nagpur Nagpur Research, Room No.G8A, Ground Floor, Sir Ganga Ram Marg, Rajinder Nagar, New Delhi New Delhi DELHI Pulmonary, Interventional Pulmonary and Sleep medicine, Rajbhavan Road, Somajiguda, Hyderabad Hyderabad ANDHRA PRADESH dryogeshsharmamd@y ahoo.com doctormanishjain2@gm ail.com gautam.moharil@gmail. com bobbybhalotra1@yahoo.co.in arjunjipmer@yahoo.co.i n Name of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee,Yashoda Academy of Medical Education & Research, Yashoda, Dr Venkata Nagarjuna Maturu Bioethical Ethics Committee, JLN Medical College, Dr Zuber Ahmad Eternal Heart Care Centre & Research Institute Institutional Ethics Committee, Eternal Heart Care Approved 19/12/2016 No Approved 28/09/2016 No Approved 05/03/2016 No page 5 / 11

6 Centre & Research Institute Pvt. Ltd., Dr. Krishna Kumar Sharma Institute Ethics Committee, NKP Salve Institute of Sciences & Lata Mangeshkar, Dr Ashish Nikahre Institute Ethics Committee, All India Institue of Medical Sciences (AIIMS), Dr Anant Mohan Institute Ethics Committee, NKP Salve Institute of Sciences & Lata Mangeshkar, Dr Balkrishna Tayade Institutional Clinical Ethics Committee (ICEC), Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj, Dr Yogesh Sharma Committee Asthma Bhawan, Dr Virendra Singh committee for Human Research, Medical College & hospital, Dr Raja Bhattacharya Committee Malpani Multispeciality, Dr Sanjay Khator Approved 31/03/2016 No Approved 25/07/2016 No Approved 31/03/2016 No Approved 15/07/2016 No Approved 04/04/2016 No Submittted/Under Review No Date Specified No Approved 04/03/2016 No Committee, B J Medical College and Civil, Dr Rajesh Solanki Approved 09/07/2016 No Committee, Fortis, Dr Amit Kumar Mandal Committee, Government Medical College, Dr K P Suraj Committee, King Georges Medical University, Dr Santosh Kumar Approved 25/03/2017 No Approved 19/05/2016 No Approved 28/06/2016 No page 6 / 11

7 Regulatory Clearance Status from DCGI Committee, Mysore Medical College and Research Institute, Dr Ranjith V Approved 30/05/2017 No Committee-AMC MET & LG, AMC MET Medical College and Sheth L.G. General, Dr Sanjay Tripathi Approved 11/04/2016 No Institutional Ethics Committee, Maharaja Agrasen, Dr Bharat Gopal Institutional Human Ethics Committee, GMERS Medical College & General, Dr Anand Patel MEDICITI ETHICS Submittted/Under COMMITTEE, Review MEDICITI HOSPITALS, Dr B Chaitanya Meditrina Institute Ethics Commitee, Meditrina Institute of Medical Science, Dr Vivek Gupta Pentamed Ethics Committee, Dr Ashish Goyal S R Kalla Memorial Ethical Committee for Human Research, S.R.Kalla Memorial Gastro & General, Dr Manish Kumar Jain Sir Ganga Ram Ethics Committee, Sir Ganga Ram, Dr Bobby Bhalotra Virtuous Institutional Medical Research Ethics Committee, Shrikrishna Hrudayalaya and Critical Care centre, Dr Gautam Moharil Status Approved 13/08/2016 No Approved 31/03/2017 No No Date Specified No Approved 20/05/2016 No Approved 27/01/2017 No Approved 09/04/2016 No Submittted/Under Review No Date Specified No Approved 28/03/2016 No Date Approved/Obtained 21/06/2016 Health Condition / Health Type Condition page 7 / 11

8 Problems Studied Patients Asthma Intervention / Comparator Agent Inclusion Criteria Type Name Details Intervention QMF /160 µg QMF /160 µg o. d. via Concept1. Duration - Intervention QMF /320 µg QMF /320 µg o. d. via Concept1. Duration - Comparator Agent Mometasone Furoate (MF) 400 µg Comparator Agent Mometasone Furoate (MF) 400 µg Active Comparator: Mometasone Furoate (MF) 400 µg o. d. MF 400 µg o.d via Twisthaler Duration - 52 weeks Active Comparator: Mometasone Furoate (MF) 400 µg b. i. d. MF 400 µg b. I. d. via Twisthaler Duration - 52 weeks Comparator Agent salmeterol /fluticasone Active Comparator: salmeterol /fluticasone salmeterol xinafoate / fluticasone propionate 50/500 µg b. I. d. via Diskus. Duration - Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1. Patients with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1 (Screening). 2. Patients who have used medium or high dose ICS or low dose of LABA/ICS combinations for asthma for at least 1 year and at stable doses for at least 1 month prior to Visit 1 3. Patients must be symptomatic at screening despite treatment with mid or high stable doses of ICS and/or combinations of low dose ICS with long-acting beta adrenergic agent. Patients must have ACQ-7 score greater than or equal to 2 at Visit 101 and at Visit 102 (prior to double-blind treatment) and qualify for treatment with medium or high dose LABA/ICS 4. Pre-bronchodilator greater than or equal to 50% FEV1 of less than 80 % of the predicted normal value for the patient after withholding bronchodilators at both Visit 101 and Withholding period of bronchodilators prior to spirometry: SABA for greater than or equal to 6 hours and FDC or free combinations of ICS/LABA for greater than or equal to 48 hours, SAMA for greater than or equal to 8 hours, LAMA for greater than or equal to 7 days, theophylline o. d. for greater than or equal to 24 hours, theophylline b. i. d. for greater than or equal to 12 hours. 6. A one-time re-testing is allowed. Re-assessment of percentage predicted FEV1 should be done in an ad-hoc visit to be scheduled on a date that would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment before randomization. 7. ICS should be continued. page 8 / 11

9 8. 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 If reversibility is not demonstrated at Visit 101: a) 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. b) Reversibility may be repeated once. c) Alternatively, patients may be permitted to enter the study with a historical positive broncho-provocation test that was performed within 2 years prior to Visit 1. Exclusion Criteria Details Exclusion Criteria 1. Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening) 2. Patients who have ever required intubation for a severe asthma attack/exacerbation. 3. Patients who have a clinical condition which is likely to be worsened by ICS administration, like for example glaucoma, cataract, fragility fractures, who are according to investigator medical opinion at risk participating in the study. 4. Patients who have had a respiratory tract infection or asthma worsening according to the definition in Section 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. 5. Patients with a history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis. 6. Patients with narcolepsy and/or insomnia. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Participant and Investigator Blinded 7. Patients on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study. Primary Outcome Outcome Timepoints 1. trough FEV1 1. trough FEV1 Secondary Outcome Outcome Timepoints Through FEV1 at week 52. week 52 pre-dose FEV1 at week 4 and week weeks page 9 / 11

10 FEV1, FVC and FEF over. PEF over 26 and. ACQ-7 at week 4, 12, 26 and 52 % patients with MID of ACQ greater than or equal to 0.5 at week 26 and 52. daily e-diary over. rescue medication use over 26 and. asthma exacerbation over. % rescue medication free days over 26 and 52 weeks. quality of life assessed by AQLQ-S 12. incidence of composite endpoint of serious asthma outcomes. Designated as safety issue: Yes Adverse event, vital signs, ECG and laboratory analysis. Designated as safety issue: Yes Target Sample Size Phase of Trial Phase 3 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary through FEV 1 at week 26. Total Sample Size=2800 Sample Size from India=450 15/07/ /12/2015 Years=2 Months=9 Days=0 Closed to Recruitment of Participants Closed to Recruitment of Participants N0 Publications provided. 1) Purpose of Trial: week 26 page 10 / 11

11 Powered by TCPDF ( PDF of Trial The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF /160 µg and QMF /320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler (total daily dose) in poorly controlled asthmatic patients as determined by pulmonary function testing, and effects on asthma control 2) FPFV from India - 20 May ) Target Sample Size from India page 11 / 11