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1 Clinical Trial Details (PDF Generation Date :- Sun, 07 Apr :40:44 GMT) CTRI Number Last Modified On 02/06/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/09/ [Registered on: 13/09/2012] - Trial Registered Retrospectively No Interventional Drug Other (Specify) [Therapy] Randomized, Parallel Group, Multiple Arm Trial A 6 Month Safety Study Comparing Symbicort with Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting?2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (more or equal 12 Years of Age) 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) Details Contact Person (Public Query) D5896C00027 dated 16 September 2011 NCT dated 30/9/2011 Designation Affiliation Protocol Number ClinicalTrials.gov Details of Principal Investigator Dr Ravindra Sarnaik Consultant Pulmonologist Leela More Chest Clinic Phone Fax Designation Affiliation Leela More Chest Clinic, 57 North Avenue, Dhantoli, Nagpur , Maharashtra Nagpur MAHARASHTRA India lmccnagpur@yahoo.com Details Contact Person (Scientific Query) Dr Ammar Raza Medical Director Phone Fax Designation Affiliation AstraZeneca Pharma India Ltd. AstraZeneca Pharma India Ltd., "Avishkar", off Bellary Road, Hebbal India ammar.raza@astrazeneca.com Details Contact Person (Public Query) Ms Ranju Sharma Sr. Clinical Research Manager AstraZeneca Pharma India Ltd. AstraZeneca Pharma India Ltd., "Avishkar", off Bellary Road, Hebbal page 1 / 8

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study India Phone Fax > AstraZeneca AB Sodertalje Sweden Type of Sponsor AstraZeneca Pharma India Ltd List of Countries Argentina Brazil Bulgaria Chile Colombia Czech Republic France Germany India Italy Mexico Panama Peru Philippines Poland Republic of Korea Romania Russian Federation Slovakia South Africa Sweden Thailand Turkey Ukraine United Kingdom United States of America Viet Nam of Principal Investigator Dr Raveendra K R Ranju.sharma@astrazeneca.com Source of Monetary or Material Support Primary Sponsor Details AstraZeneca AB Sodertalje Sweden Pharmaceutical industry-global "Avishkar", P.B. No 2483, off Bellary Road, Hebbal, , India. of Site Site Phone/Fax/ Associate Professor, Room no 72/A, 2nd Department of Medicine Floor, Medicine New C page 2 / 8

3 Block, Victoria Hospital Fort, , Karnataka India Dr Nagraj Boyilla Axon Hospitals , Opposite ICICI Bank, Ameerpet Main Road, Sanjeeva Reddy Nagar, Hyderabad Hyderabad ANDHRA PRADESH Dr Animesh Arya Dr KS Satish Dr S Nagarajan Dr Rajesh Swarnakar Dr Jayamohan Unnithan Dr Ravindra Sarnaik Centre for Chest Disease Chest and Maternity Centre Coimbatore Chest Clinic Getwell Hospital and Research Institute Kovai Respiratory Care and Research Centre Allergy & Sleep Disorders, B-3/17, Paschim Vihar, near Jwala Heri Mkt, New Delhi New Delhi DELHI No 878,5th Block Rajajinagar Karnataka M.S.S Memorial Buildings, D. B. Road, R. S. Puram, Coimbatore Tamil Nadu Coimbatore TAMIL NADU Plot No: 20/1, Khare Marg, Dhantoli, Nagpur Maharashtra Nagpur MAHARASHTRA 45, Vivekananda Road Ramnagar, Coimbatore Tamil Nadu Coimbatore TAMIL NADU Leela More Chest Clinic 57 North Avenue, Dhantoli, Nagpur , Maharashtra Nagpur MAHARASHTRA Dr Binu Krishnan P.R.S Hospital Department of Pulmonary and Critical care Medicine, Killipalam, Trivandrum Kerala Thiruvananthapuram KERALA Dr Jayaraju B S Professor, Head of the department, J.S.S Medical College and Hospital Ramanuja Road, Mysore , Karnataka India drkrraveendra@gmail.c om drnagaraj.b@gmail.com dranimesharya@gmail. com mamthasatish@gmail.c om nagrajsri@gmail.com dr.rajesh@lungscare.co m unnithan2@gmail.com lmccnagpur@yahoo.co m binukrishnanck@hotmai l.com drjayarajbs@yahoo.co m page 3 / 8

4 Details of Ethics Committee Dr Ajit Bhaskar PVS Hospital PVS Hospital, 1st Floor, New Block, Railway Station Road Calicut Kerala Kozhikode KERALA Dr Vishnu Rao Dr A Mesquita Dr Hanraj Alva Swasa Allergy asthma special care and research centre Opposite Universal Bakery Beside TTD Temple( Kalyana Mandapam), Liberty Circle Himayathnagar, Hyderabad Hyderabad ANDHRA PRADESH T. B and Chest Hospital Dept of Respiratory Medicine, St. Inez P.O Caranzelem, Goa North Goa GOA Vinaya Hospital and Research Centre Research Centre, P.O. 717, Karangalpady Mangalore Karnataka cardisindiahealthcare@ gmail.com vishnunrao@yahoo.co m mesquita@bsnl.in drhansraj@epsilon.net.i n of Committee Approval Status Date of Approval Is Independent Ethics Committee? Axon Institutional Ethics Commiittee, ,Srinivasa Nagar Colony,Opposite ICICI Bank,Ameerpet Main Road,Sanjeeva Reddy Nagar,Hyderabad Central Ethics Committee,No 1423,Kullappa Circle, St. Thomas Town post, , Karnataka Breathe Trust Ethics Committee,North Avenue Road,Dhantoli,Nagpur , Maharashtra Canara Research Ethical Committee,Mangalore Heart Scan Foundation,Kumar s International,Opp Colaco Hospital,Bendo orwel,mangalore , Karnataka Approved 10/04/2012 No Approved 19/03/2012 Yes Approved 21/04/2012 Yes Approved 28/03/2012 Yes Coimbatore Approved 24/04/2012 Yes page 4 / 8

5 Independent Ethics Committee,93,6th Street Extension,Gandh ipuram, Coimbatore , Tamil Nadu Daksh Independent Ethics Committee, H No 1-29/190, Jai Jawan Colony, Kapra, ECIL Post, Hyderabad, ,Andhra Pradesh INDIA Approved 12/04/2012 Yes Ethics committee of Medical College & Research Institute, K R Road, Fort, GRACE Ethics Committee,Manobal Kilink Rajouri Garden,New Delhi Independent Ethics Co mmittee,20/1,dhantoli, Nagpur ,Maharahstra Institutional Ethical Committee, JSS Medical College, SS Nagar, Mysore Institutional Ethics Committee, PVS Hospital,Constitution of Institutional Ethics Committee,Railway Station Road,Kozhikode , Kerala Institutional Ethics Committee,Coimbatore Chest Clinic,M.S.S Memorial Buliding,Opp Savitha Hall,8, D.B. Road,R. S. Puram,Coimbatore ,Tamil Nadu Institutional Ethics Committee,Department of Pharmacology,Goa Medical College,Bambolim Complex,Goa PRS Hospital,Ethics Committee,Killipalam, Trivandrum ,Kerala Approved 04/09/2013 No Approved 25/08/2012 Yes Approved 02/04/2012 Yes Approved 02/09/2013 No Approved 23/03/2012 No Approved 16/04/2012 No Approved 14/03/2012 No Approved 18/04/2012 Yes Regulatory Clearance Status Date page 5 / 8

6 Status from DCGI Approved/Obtained 01/08/2012 Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Health Type Patients Condition Asthma Type Details Intervention Symbicort pmdi 80/4.5?g x 2 actuations bid (morning and evening), for oral inhalation, 26-week treatment 160/4.5?g x 2 actuations bid (morning and evening), for oral inhalation, 26-week treatment Comparator Agent Budesonide pmdi 80?g x 2 actuations bid (morning and evening), for oral inhalation, 26-week treatment 160?g x 2 actuations bid (morning and evening), for oral inhalation, 26-week treatment Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal Male or Female,more or equal 12 years of age Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2 Patient must have history of at least 1 asthma exacerbation including one of the following: o requiring treatment with systemic corticosteroids o an asthma-related hospitalization between 4 weeks and 12 months prior to randomization Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire Exclusion Criteria Details Exclusion Criteria Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support. Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2 Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable) An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigators opinion, will interfere with the patients lung function Patient must not meet unstable asthma severity criteria as listed in the protocol Peak expiratory flow must not be below 50% o predicted normal page 6 / 8

7 Pregnancy, breast-feeding or planned pregnancy during the study Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Participant, Investigator and Outcome Assessor Blinded Primary Outcome Outcome Timepoints 1. Time to first event in composite endpoint 1. Up to 27 weeks (asthma-related death, asthma-related intubation 2. Up to 26 weeks or asthma-related hospitalization) 2. Time to first event included in the definition of asthma exacerbation (Asthma exacerbations, defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 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 1. Percent of days with no asthma symptoms 2. Percent of days with no activity limitation due to asthma 3. Asthma Control Questionnaire (ACQ6) Total Sample Size=11700 Sample Size from India=700 05/11/ /12/2011 Years=4 Months=0 Days=0 Completed Completed 1. daily up to 26 weeks 2. daily up to 26 weeks 3. baseline, day 28, day 84, day 182 Following the December 2008 Food and Drug Administration (FDA) Advisory Committee and based on an internal review of data, FDA continued to have outstanding questions on whether the addition of a LABA to an ICS increases the risk of asthma related serious adverse events (SAEs). Therefore FDA requested all manufacturers of LABA-containing products indicated for the treatment of asthma to undertake the following: class-labelling changes and the conduction of a post-marketing safety study. page 7 / 8

8 Powered by TCPDF ( This study has been designed to evaluate whether the addition of formoterol to budesonide maintenance therapy increases the incidence of serious asthma related events compared to budesonide during a 26-week treatment period in patients with persistent asthma. The treatment arms in this study are identical to active-treatment arms in previous Symbicort pmdi studies evaluating the recommended doses of Symbicort in the US. Patients treated in the budesonide-only arm will derive benefit from treatment with ICS medication consistent with standard medical practice. The risk/benefit profile is therefore considered to be appropriate in both treatment arms. Patients will be followed at least on a monthly basis by the research site, either by monthly clinic visits or monthly telephone contacts. Unstable asthma will be assessed between study visits on a daily basis via telephone calls to the Interactive Voice Response System (IVRS). The Investigator will receive an electronic alert to contact patients with unstable asthma. Patients in need of treatment due to an exacerbation can obtain additional medication while remaining on randomized treatment. page 8 / 8