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1 CTRI Website URL Clinical Trial Details (PDF Generation Date : Tue, 21 Aug :05:28 GMT) CTRI Number Last Modified On 03/12/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/11/ [Registered on: 06/11/2012] Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Active Controlled Trial To assess safety, efficacy and tolerability of Formoterol Budesonide nebulised formulation in comparison with Formoterol Budesonide pressurized meter dose formulation in COPD patients A randomized, open label, activecontrolled, parallel group, multicenter 6 weeks study to determine safety, tolerability and efficacy of nebulised formulation of Formoterol Budesonide combination in comparison with pressurized meter dose formulation of Formoterol Budesonide combination in Chronic Obstructive Pulmonary Disease (COPD) patients Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multicenter study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) CP/01/12 Designation Affiliation Protocol Number Details of Principal Investigator Dr Sundeep Salvi Director Phone Fax Designation Affiliation Chest Research Foundation Chest Research Foundation, Marigold Premises, Survey No.15, Vadgaon Sheri, Kalyani Nagar, Pune Pune ssalvi@crfindia.com Details Contact Person (Scientific Query) Dr Jaideep Gogtay Head Medical Services Cipla Ltd. Phone Fax Designation Affiliation Cipla Ltd. Bellasis Road, Mumbai Central, Mumbai Mumbai jgogtay@cipla.com Details Contact Person (Public Query) Mr Abhijit Vaidya Project Manager Cipla Ltd. Cipla Ltd., 3rd Floor, Raj Plaza, LBS Marg, Vikhroli (West), Mumbai Mumbai page 1 / 6

2 CTRI Website URL Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > Cipla Ltd, Bellasis Road, Mumbai Central, Mumbai, Phone Fax Cipla Ltd Primary Sponsor Details Bellasis Road, Mumbai Central, Mumbai, Phone: (022) Fax: (022) Type of Sponsor NIL List of Countries of Principal Investigator Dr Hiren Pandya Pharmaceutical industryn NIL of Site Site Phone/Fax/ AMC MET Medical College and L.G. Hospital AMC MET Medical College and L.G. Hospital, Rambaug, Maninagar Ahmedabad Ahmadabad GUJARAT Dr Nagaraj Boyilla Axon Hospital AXON Hospitals,83215, Srinivasanagar, Colony (West), S.R. Nagar, Ameerpet Main Road, Opp. ICICI Bank, Hyderabad , Andhra Pradesh Hyderabad ANDHRA PRADESH Dr Sundeep Salvi Dr Sanjiv Walanj Dr Vivek Nangia Chest Research Foundation Ethika Clinical Research Centre Fortis Flt Lt. Rajan Dhall Hospital Chest Research Foundation, Marigold Premises, Survey No.15, Vadgaon Sheri, Kalyani Nagar, Pune Pune Ethika Clinical Research Centre Siddeshwar Arcade, Bwing First Floor Behind Prakruti hospital Opp. Manisha Nagar, Gate no.1 Kalwa Thane(West) Thane Fortis Flt Lt. Rajan Dhall Hospital, B1, Aruna Asaf Ali Marg, Vasant Kunj, New com om m page 2 / 6

3 CTRI Website URL Details of Ethics Committee Delhi New Delhi DELHI Dr Raja Dhar Fortis Hospital Fortis Hospital, #730, Anandapur, EM Bypass Road, Kolkata Kolkata WEST BENGAL Dr Mohan Rao Dr Praveen Pandey M S Ramaiah Memorial Hospital Max Super Speciality Hospital M S Ramaiah Memorial Hospital Department of Chest Medicine, New BEL Road, MSRIT Post, Bangalore Bangalore KARNATAKA Max Super Speciality Hospital, 108 A, Indraprastha Extension, Patparganj, Delhi East DELHI Dr Vikrant Deshmukh Nagpur Chest Center Nagpur Chest Center, 25, Amarjyoti Palace, Dhantoli, Nagpur , Maharashtra, Nagpur Dr Aloke Gopal Ghoshal Dr Balkrishna Tayade National Allergy Asthma Bronchitis Institute NKP Salve Institute of Medical Science & Lata Mangeshkar Hospital docaardee@yahoo.com kotnur.rao@gmail.com pkpandey2005@gmail. com vikrant9825@gmail.co m National Allergy Asthma Bronchitis Institute, 11/3 Dr. Biresh Guha Street, agghosal@yahoo.com Park Circus, IMA House, 2nd Floor, Kolkata Kolkata WEST BENGAL NKP Salve Institute of Medical Science & Lata Mangeshkar Hospital, Digdoh Hill,Hingna Road, Nagpur Nagpur botayade123@gmail.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? AMC MET Ethics committee for Dr. Hiren Pandya Axon Hospitals Axon Committee, Hyderabad for Dr Boyilla Balaji Medical and Diagnostic Research Centre Ethics Approved 22/04/2013 No Approved 15/10/2012 No Approved 04/01/2013 No page 3 / 6

4 CTRI Website URL Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Committee Max Super Speciality Hospital for Dr Pandey Ethics Committee for Research for Dr Vivek Nangia Fortis Hospital Ethics Committee, Kolkata for Dr. Raja Dhar Independent Ethics Committee, Snehal Hospital, Thane for Dr. Sanjiv Walanj Committee for Chest Research Foundation, Pune for Dr. Sundeep Salvi. Committee Global Hospitals and Health City Tamil Nadu for Dr. Vijil Rahulan Committee National Allergy Asthma Bronchitis InstituteKolkata for Dr. A G Ghoshal. Committee NKP Salve Institute of Medical Sciences & Lata Mangeshkar Hospital, Nagpur for Dr. Tayade Nagpur Independent Ethics Committee for Nagpur Chest Center, NagpurDr. Deshmukh Status Not Applicable Health Type Patients Approved 02/01/2013 No Approved 17/10/2012 No Approved 13/07/2013 Yes Approved 08/12/2012 No Approved 26/11/2012 No Approved 18/10/2012 No Approved 06/12/2012 No Approved 22/10/2012 Yes Date No Date Specified Condition Patient diagnosed with COPD Type Details Intervention Formoterol Budesonide Respules (20 mcg /1 mg) manfactured by Cipla Comparator Agent Formoterol Budesonide pmdi (6 mcg /200 mcg) manfactured by Cipla Age From Age To Gender Year(s) Year(s) Both Inclusion Criteria nebulization over 10 minutes twice daily two puffs twice daily page 4 / 6

5 CTRI Website URL Details 1. Patient and/or LAR willing to give a written informed consent. 2. Patient of either sex aged above 40 years. 3. Patient diagnosed with COPD as per GOLD guidelines (post bronchodilator FEV1/FVC ratio 4. Patient with documented history of COPD for at least the past 6 months and who are on stable dose of COPD medication (monotherapy or combination) for at least 4 weeks prior to screening visit Postbronchodilator FEV1?50% of the predicted normal value (as per the European Community for Coal and Steel formula and applying the correction factor of 0.9) when not taking shortacting bronchodilator medication for the previous 6 hours, ICS+LABA atleast 24 hours, LABA+LAMA atleast 48 hours, LAMA atleast 48 hours prior to visit. 6. Current and exsmoker with a smoking history of at least 10 packyears for cigarette and equivalent for bidi smoking. 7. Patient able to use inhaler + Zerostat VT spacer and nebulizer in their respective groups Exclusion Criteria Details Exclusion Criteria 1. History of asthma or any chronic respiratory disease other than COPD. 2. Long term administration of supplemental oxygen (15 hours/day) 3. Hospitalization for pulmonary exacerbation within the past one month or as per Investigator s discretion. 4. Lifethreatening/unstable respiratory status, including upper respiratory tract infection, within the previous 4 weeks or lower respiratory tract infection, within the previous 12 weeks. 5. History of lung resection of more than one full lobe. 6. Severe unstable or uncontrolled cardiovascular disorder, other pulmonary disease, clinically significant hematological, endocrine, electrolyte, renal or hepatic abnormality 7. Any clinically significant lab values as per investigators discretion. 8. Pregnant or lactating or planning to become pregnant 9. Have a known hypersensitivity to Investigational product or any of the excipients contained in study medicines. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Other Open Label 10.Treatment with any investigational drug in last 30 days prior to screening visit 1. page 5 / 6

6 Powered by TCPDF ( PDF of Trial CTRI Website URL Primary Outcome Outcome Timepoints Mean change in prebronchodilator FEV1 & FVC Mean change in prebronchodilator FEV1 & FVC Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Mean change in postbronchodilator FEV1 Change in postbronchodilator FEV1 Change in postbronchodilator FVC Change in pre and post bronchodilator FEF2575 Difference in use of number of puffs of rescue medication Change in COPD questionnaire at week 6 from baseline Incidence of adverse events Incidence of drug related adverse events Incidence of COPD requiring emergency attendance, treatment with oral steroid and hospitalization Total Sample Size=120 Sample Size from =120 06/11/2012 No Date Specified Years=1 Months=0 Days=0 Not Applicable Closed to Recruitment of Participants Not published in any journal. baseline to end of 6 weeks 2 and 4 weeks 2 and 4 weeks baseline to end of 6 weeks During study period During study period During study duration During study duration During study duration This is a 6 weeks phase IV multicenter study to determine safety, tolerability and efficacy of nebulised formulation of Formoterol Budesonide combination in comparison with pressurized meter dose formulation of Formoterol Budesonide combination in Chronic Obstructive Pulmonary Disease (COPD) patients. 120 Patients will be enrolled into the study from at least 10 participating centers in. From these 120 patients, 80 patients will be given Formoterol Budesonide nebulization therapy and 40 patients will be given Formoterol Budesonide pmdi for the duration of 6 weeks.the primary end point of the study is to determine mean change in prebronchodilator FEV1 & FVC from baseline to end of 6 weeks. Incidence of adverse events will be determined as safety endpoints. Incidence of COPD exacerbation requiring emergency attendance, treatment with oral steroid and hospitalization will also be observed. page 6 / 6