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1 Clinical Trial Details (PDF Generation Date :- Sun, 22 Apr :27:45 GMT) CTRI Number Last Modified On 09/10/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/05/ [Registered on: 07/05/2013] - Trial Registered Prospectively Interventional Drug Randomized, Parallel Group, Active Controlled Trial A clinical trial to study the effects of Fixed Dose combination Capsule of Formoterol Fumarate And Budesonide powder for inhalation in asthmatic patients A Phase III, Randomized, Open Label, n- Inferiority, Comparative, Multicentric, Parallel Group Study Between Glenmark s Fixed Dose combination Capsule of Formoterol Fumarate And Budesonide powder for inhalation (12µg + 400µg) and Alenia (Fixed Dose combination of Formoterol 12µg / Budesonide 400 µg) Inhalation Capsule in Asthmatic Patients. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) GPL/CT/2012/006/III; version 1.0 dated: Name Designation Affiliation Address Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Name Designation Affiliation Address Details Contact Person (Scientific Query) Dr Ashish Dhabre Manager - Medical Services Phone Fax Name Designation Affiliation Address Glenmark Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Glenmark House, BD Sawant Marg, Chakala Andheri East, Mumbai Mumbai India ashishdh@glenmarkpharma.com Details Contact Person (Public Query) Dr Shailendra Sachan Manager- Medical Writing Glenmark Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Glenmark Research Centre, Plot. A-607, T.T.C. Industrial Area, MIDC, Mahape, Navi Mumbai Thane India page 1 / 10

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Glenmark Pharmaceuticals Ltd Name Address Type of Sponsor Name NIL List of Countries India Name of Principal Investigator Dr Prakash Kurmi Dr Narayan Deogaonkar Source of Monetary or Material Support Primary Sponsor Details Glenmark Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Glenmark House, B D Sawant Marg Chakala, Andheri (East), Mumbai, India Pharmaceutical industry-indian Address NIL Name of Site Site Address Phone/Fax/ Shivam Medical Hospital Deogaonkar Hospital Clinical Research Department, C/4, Satyanarayan Society, Nr. Jasodanagar Char Rasta, Ahmedabad , Gujarat Ahmadabad GUJARAT Department of Medicine, Old Pandit Colony, Gangapur Road, Nasik-2, Maharashtra Nashik Dr Shailesh Adwani Apex Hospital Department of Medicine, Kalewadi Phata, Thergaon, Chinchwad , Pune, Maharashtra Pune Dr Mrs Jyoti Gulati Shree Shakti Hospital Department of Medicine,59/3 Pimple - saudagar, Pune , Maharashtra Pune Dr Yogeesha KS Omega Hospital Basement, Mahaveer Circle, Kankanady Mangalore , Karnataka Dakshina Kannada Dr Hema Malathi IPGMER-SSKM Department of Medicine, Hospitals, 244, AJC Bose road, Kolkata dr_prakashkurmi@yaho o.co.in drnarayan_04@yahoo.c o.in sradwani@yahoo.com drgulati22@gmail.com yogeeshaks@ymail.co m hema0278@yahoomail. com page 2 / 10

3 Dr B R Shivakumar Dr Vipul Khandelwal Cosmopolitan Medical Centre Kolkata WEST BENGAL NO.8, 5 th Main Mariappa Road (Kullappa Circle), Kammanahalli, St.Thomas Town Post, Bangalore , Karnataka Bangalore Apex Hospitals Pvt. Ltd. SP 4 & 6 Malviya Industrial Area, Malviya Nagar, Jaipur Jaipur RAJASTHAN Dr Bobby Bhalotra Sir Gangaram Hospital PFT Lab, 1st Floor, Sir Ganga Ram Hospital Marg, Rajinder nagar, New Delhi New Delhi DELHI Dr Rufino Vintage Hospital & Medical Research Centre Pvt. Ltd. Caculo Enclave, Stress test lab, 1st floor, St. Inez, Panaji, Goa rth Goa GOA Dr Vishnun Rao Swasa Hospital 2nd Floor, 201, Skill Spectrum, Beside TTD, Himayatnagar, ANDHRA PRADESH Dr Hansraj Alva Dr Balkrishna Tayade Dr RC Sahoo Dr K Srikanth Vinaya Hospital & Research Centre N K P Salve Institute of Medical Sciences and Research Center and Lata Mangeshkar Hospital Kasturba Medical College and Hospital Sri Bala Medical center and Hospital 1st Floor, OPD, Karangalpady, Mangalore , Karnataka Dakshina Kannada Digdoh Hills, Hingana Road, Nagpur Nagpur 1st Floor, Department of Respiratory and Pulmonology, Ambedkar Circle,,Mang alore , Karnataka Dakshina Kannada 2nd Floor, Room. 312, Department of Pulmonology, 901,Trichy Road, Ramanathpuram, Coimbatore dr_shiva_kumar@yaho o.co.in dr.vipul@yahoo.co.in bobbybhalotra1@yahoo.co.in clinicalresearchgoa@g mail.com vishnunrao@yahoo.co m hansalva2001@yahoo. com botayade123@gmail.co m sahoo.rc@manipal.edu drsrikanthcbe@gmail.c om page 3 / 10

4 Dr S Subramanian Chettinad Hospital Research Institute Coimbatore TAMIL NADU 2nd Floor, Pulmonology department, Rajiv Gandhi, Salai, Kalambakkam, Kanchipuram, Tamil nadu Kancheepuram TAMIL NADU chettinad.research@gm ail.com Dr Md Samiuddin Vasavi Hospital OPD Block, 1st Floor, Beside Vasavi Seva Kendran, Lakdi ka drsamiuddin@hotmail.c Pool, om ANDHRA PRADESH Dr Manjunath M Dr Anil Kashyap Dr Hiren Pandya Dr Mohan Rao Kotnur Narayana Dr KM Veeranna Gowda Sapthagiri Institute of Medical Sciences and Research centre Dhaynad Medical College and Hospital Swapn Healthcare Hospital Pvt Ltd M.S Ramaiah Medical College and Hospital Victoria Hospital Department of General Medicine, 1st Floor, #15, Chikkasandra, Hesargatta main Road, Bangalore Bangalore Department of Pulmonary Medicine, 2nd Floor, D.M.C. Road, Tagore Nagar, Ludhiana , Punjab. Ludhiana PUNJAB Ground floor, Clinical Research Department, Sardar Complex, Opposite Govindwadi, Isanpur, Ahmedabad , Gujarat India. Ahmadabad GUJARAT Department of Chest Medicine, Ground Floor, Room. 6, New Bel Road, MSRIT Post, Banglore Bangalore 1st Floor, C Block, Department of Medicine, Fort, K. R. Road, Bangalore , Karnataka Bangalore Dr Naseem Mulla KEM Hospital Rasta Peth, Sardar Moodliar Road, Pune Pune suri@rediffmail.com anildoc11@gmail.com drhirenpandya@yahoo. com kotnur.rao@gmail.com veerannakm@gmail.co m drnaseemmulla@gmail. com page 4 / 10

5 Details of Ethics Committee Dr Nageswari Dr Ram Kushwaha Dr Suhas Kalashetti Dr Ashish Kumar Malpani Dr Ramanathan Dr Nanyam Srinivasa Rao SRM Medical College Hospital & Research Centre King Georges Medical u niversity,(estcohile)(sm MU) Ground Floor, Pulmonology department, SRM University, SRM Nagar, Kattankulathur, Kanchipuram(Dst), Chennai , Tamil Nadu Chennai TAMIL NADU Department of Pulmonary Medicine Shahmina Road, Chowk, Lucknow ,U.P, Lucknow UTTAR PRADESH Shree Samarth Hospital 227, Rasta Peth, Omkar Apts Karande Chowk, Pune Pune Asthma Bhawan PSG Institute of Pulmonary Medicine Osmania Hospital, Osmania Medical College Department of Pulmonology, Basement, R - 3, Sector - 6, Vidhyadhar Nagar, Jaipur Jaipur RAJASTHAN 5th Floor, Avinashi Road, Peelamedu, Coimbatore , Tamil Nadu Coimbatore TAMIL NADU Afzalgunj ANDHRA PRADESH Dr E Ravindra Reddy Kamineni Hospital Department of Pulmonology, Basement, OPD. 4. Lal Bahadur Nagar, Dilsukh Nagar, Cross Road, ANDHRA PRADESH Dr Vivek Gupta Suretech Hospital & Research Center Limited srmclinicaltrials@gmail. com kushwaharas_kgmu@r ediffmail.com skalashetti@yahoo.com drashish19@gmail.com ramanathanrmpl@hotm ail.com drnanyam@yahoo.com rvndrreddy@yahoo.com Department of Pulmonology, Basement, Room. B vivekurvashi@yahoo.co 06,13-A Banerjee.in Marg, Dhantoli, Nagpur Nagpur Name of Committee Approval Status Date of Approval Is Independent Ethics page 5 / 10

6 Apex Hospital Ethics Committee, Pune Bangalore Medical College & Research institute, Victoria Hospital, Banglore Canara Research Ethical Committee Mangalore heart scan foundation, Vinaya Hospital & Research Centre, Mangalore Daksh Independent ethics committee, Swasa Hospital, Deogaonkar Hospital Ethics, Nashik Drug Trial Ethics Committee, Dayanad Medical college and hospital, Ludhiana Ethics committee Apex Hospital Pvt Ltd, Jaipur Ethics Committee of KEM hospital research centre, Pune Osmania Hospital, Osmania Medical College, Ethics Board, M.S Ramaiah Medical College and Hospital, Bangalore Institutional EC, Sir Gangaram Hospital, New Delhi Institutional Ethics Committee, SRM Medical College & Research Centre, Chennai Institutional ethics committee, IPGMER-SSKM Hospital, Kolkata Approved 24/12/2012 Committee? Approved 19/01/2013 Yes Yes Approved 04/02/2013 Institutional Ethics Committee, King Georges Medical univer sity,(estcohile)(smmu), Lucknow Institutional Ethics Committee, N K P Salve Institute of Medical Sciences and Approved 17/01/2013 page 6 / 10

7 Research Center and Lata Mangeshkar Hospital, Nagpur Institutional Human Chettinad Hospital And Research Institute, Kalambakkam, Institutional Human Sri Bala Medical center and Hospital, Coimbatore Kamineni Institutional Ethics Committee,Kamineni Hospital, Mahalasa Independent Sree Samarth Hospital, Pune Manipal University Kasturba Medical College and Hospital, Manipal Nagpur Independent Suretech Hospital & Research Center Limited, Nagpur Omega Ethics Committee, Omega Hospital, Kankanady Mangalore Sapthagiri Institute of Medical Sciences and Research centre, Institutional Ethics Committee, Bangalore Shivam Ethics Committee, Shivam Medical Hospital, Ahmedabad Shree Shakti Hospital IRB, Pune Swapn ethics Committee, Swapn health care hospital Pvt Ltd, Ahmedabad Swasthya Kalyan Ethics Committee, Asthma Bhawan, Jaipur Synapse Ethics Committee, Cosmopolitan Medical Centre, Bangalore Approved 13/02/2013 Approved 10/01/2013 Approved 21/01/2013 Yes Approved 03/01/2013 Approved 17/12/2012 Approved 10/01/2013 Approved 12/01/2013 The Human Institutional Yes page 7 / 10

8 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria PSG Institute of Pulmonary Medicine, Coimbatore Vasavi Institutional Vasavi Hospital, Vintage Institutional Vintage Hospital & Medical Research Centre Pvt. Ltd., Panaji Status Approved 30/11/2012 Date Approved/Obtained 05/12/2012 Health Type Patients Condition Asthma Type Name Details Intervention Comparator Agent Age From Age To Gender Details FDC of Formoterol Fumarate and Budesonide inhalation capsule (12µg + 400µg) Alenia (FDC of Formoterol 12µg / Budesonide 400 µg) Inhalation Capsule Year(s) Year(s) Both Inclusion Criteria 1 capsule to be inhaled two times daily, for 1 capsule to be inhaled two times daily for 1. Male or female outpatients aged?12 to?65 years, with stable persistent asthma 2. Clinical diagnosis of asthma for at least 6 months prior to screening and FEV % of predicted normal (pre-bronchodilator) value 3. Patients able to demonstrate at least?12% and?200ml improvement in FEV1 from the pre-bronchodilator value within 30 minutes (±10mins) after inhalation of Salbutamol 400?g 4. Patient willing to perform all study related procedures including the use of study inhalers, Spirometry and peak flow meter and willing to complete the patient diary Exclusion Criteria Exclusion Criteria Details 1. COPD as defined by the European Respiratory Society (ERS) Consensus Statement 2. Patients with history of more than 10 packs/year of cigarettes and current smokers 3. Patients with a history of hypersensitivity to Formoterol / Budesonide and or any other ingredients 4. History of near fatal asthma and / or admission in intensive care unit because of asthma within past one year. 5. Female subjects who are pregnant, nursing or planning a pregnancy during the study 6. History of alcohol and/or substance abuse within 12 months prior to the Screening Visit 7. Subjects who have participated in another investigational drug or device research study within 30 days of enrolment 8. Subjects who are using any medication or has any disease which page 8 / 10

9 in the judgment of the investigator will interfere with the conduct or interpretation of the study Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization t Applicable Open Label Primary Outcome Outcome Timepoints The mean difference between groups in Forced Expiratory Volume in 1 second (FEV1) at the End of Treatment Visit Secondary Outcome Outcome Timepoints 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 Mean change in PEFR from baseline to End of Treatment Visit Mean change in day-time & night-time asthma symptoms score from baseline to end of treatment visit Average need for short acting beta 2 agonist (puffs/day/patient) during the study period Mean number of days without nocturnal awakening during 12 week of treatment period Overall global impression of change as assessed by patient and investigator at the end of treatment visit Total Sample Size=280 Sample Size from India=280 01/06/2013 Years=1 Months=0 Days=0 t Applicable Suspended This is a randomized, open label, comparative, parallel group, non inferiority, multicentric study. The study will be conducted in patients of either sex, aged?12 to?65 years, with a diagnosis of Asthma having FEV1 of?50% to?90% of the predicted normal value. Study will enrol 280 patients across different centers from India. Patients will be recruited after providing written informed consent. After screening and run-in period, patient will be randomized in 1:1 ratio to receive either Fixed Dose combination Capsule of Formoterol Fumarate and Budesonide for inhalation (12µg + 400µg) or Alenia (Fixed Dose combination of Formoterol 12µg / Budesonide 400 µg) Inhalation Capsule. page 9 / 10

10 Powered by TCPDF ( REF/2013/04/ The primary objective of the study is to evaluate the effect of study drug on lung function as assessed by FEV1 after the therapy. Secondary objective includes Change in PEF, asthma symptoms, number of asthma exacerbations, average need for use of short acting?2 agonists and safety. Patients will be followed for safety and efficacy assessment at week 4, 8 and 12 after start of therapy. page 10 / 10