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1 Clinical Trial Details (PDF Generation Date : Sun, 30 Dec :59:17 GMT) CTRI Number CTRI/2009/091/ [Registered on: 15/06/2009] Last Modified On 14/08/2014 Post Graduate Thesis Type of Trial Type of Study Study Design No Interventional Drug Randomized, Parallel Group, Active Controlled Trial Public Title of Study A Clinical Trial to compare the efficacy and safety of Fluticasone / Formoterol with Budesonide / Formoterol combination administered with an inhaler in subjects with moderate to severe asthma. Scientific Title of Study A 12 weeks, double blind, prospective, active controlled, comparative; parallel group, multicenter study to assess the efficacy and safety of Fluticasone / Formoterol versus Budesonide / Formoterol combination administered through a pressurized Metered Dose Inhaler (pmdi) in subjects with moderate to severe Bronchial Asthma. 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/08/08 Version 1, dated January 16, 2009 Designation Affiliation Address Protocol Number Details of Principal Investigator Dr Salil Bhargava Phone Fax Designation Affiliation Professor of Pulmonary medicine Gyanpushp Research Centre for Chest & Allergy Diseases Surabhi; 76, Dhar Kothi, Residency Area, Behind Saint Rapheals School, Gyanpushp Research Centre for Chest & Allergy Diseases bhargavasalil@hotmail.com Details Contact Person (Scientific Query) Dr Jaideep A Gogtay Medical Director Cipla Ltd Address Cipla Ltd. Bellasis Road, Mumbai Central, Mumbai Mumbai Phone Fax Designation Affiliation Address jgogtay@cipla.com Details Contact Person (Public Query) Dr Salil Bhargava Professor of Pulmonary medicine Gyanpushp Research Centre for Chest & Allergy Diseases Surabhi; 76, Dhar Kothi, Residency Area, Behind Saint Rapheals School, Gyanpushp Research Centre for Chest & Allergy Diseases page 1 / 7

2 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 Primary Sponsor Details Cipla Ltd Bellasis Road Mumbai Central Mumbai Phone Fax Address Bellasis Road, Mumbai Central, Mumbai, Phone: (022) Fax: (022) Type of Sponsor NIL List of Countries of Principal Investigator Pharmaceutical industryn Address of Site Site Address Phone/Fax/ Dr Bharat Trivedi Nashik Rugnalaya Doctor House, Bhabha Nagar Kaut Ghat Road, Mumbai Agra Road, Nashik Nashik m Dr Sonia Dalal Ashray Chest Centre , Kalyan Polyclinic, Shree Hari Complex, Behind Express Hotel, Alkapuri, om Vadodara, Vadodara GUJARAT Dr Ajeet Singh Asthma Bhawan R3,Sector 6,Near Cinestar, Vidhyadhar Nagar,Jaipur,Rajasthan , Jaipur RAJASTHAN Dr Animesh Arya Dr K N Poddar Centre for Chest Diseases Allergy & Sleep Disorders Chest Asthma and Allergy Clinic B3/17, Ground Floor, Paschim Vihar, Near Jwala Heri Mkt., New Delhi New Delhi DELHI 91, Vivekanand Road, Girish Park, Kolkata Kolkata WEST BENGAL Dr Akash Balki Chest Care Hospital 204,Everest Arcade, 2nd floor, Sakkardara Square, Umred Road, Nagpur Nagpur dr.ajeetsingh@yahoo.c om dranimesharya@hotmai l.com drknpoddar@yahoo.co m akash_balki@yahoo.co m Dr S Balamurugan Chest Clinic No.2, 1st Cross Street, page 2 / 7

3 Details of Ethics Committee Dr Rajendra Mehta Dr Salil Bhargava Dr. Mehtas Allergy & Asthma Care And Research Centre Gyanpushp Research Centre for Chest & Allergy Diseases Janaki Nagar Extn, Valasaravakkam, Chennai, Chennai TAMIL NADU 107, Asawa Chambers, Sapna Sangeeta Road, Surabhi; 76, Dhar Kothi, Residency Area, Behind Saint Rapheals School, Gyanpushp Research Centre for Chest & Allergy Diseases Dr B K Mutha Mutha Hospital P67, MIDC Satpur, Behind ITI, Trimbak Road Nashik Nashik Dr Shrikant Papinwar Papinwar Hospital Plot No. 57, Mahesh Nagar, In front of S.F.S School, Jalna Road, Beside Kabra Hospital, Aurangabad, Aurangabad Dr Surya Kant Sahar Hospital 6, Nabi Ullah Road, Near City Station, Lucknow, Lucknow UTTAR PRADESH Dr Sameer Chandratre Shatabdi Hospital Suyojit City Centre, Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik, Nashik Dr Suhas Bardapurkar Shree Nursing Home 15, Sujay, Sanmitra Colony, Near Daily Marathwada, Aurangabad, Aurangabad Dr B P Singh Surya Chest Foundation 16/1326, Indra Nagar, Lucknow Lucknow UTTAR PRADESH dr.s.bala@gmail.com drrajendramehta@hotm ail.com bhargavasalil@hotmail. com drbkmutha@yahoo.co.i n drshrikantpapinwar@g mail.com dr.kantskt@rediffmail.c om sameer.chandratre@g mail.com drsuhasbardapurkar@g mail.com bps2159@yahoo.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ashray Chest Centre page 3 / 7

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Asthma Bhawan Centre for Chest Diseases Allergy & Sleep Disorders Chest Asthma and Allergy ClinicDr.Poddar clinic Chest Care Hospital Chest Clinic Dr. Mehtas Allergy & Asthma Care And Research Centre Mutha Hospital Nashik Rugnalaya Papinwar Hospital Sahar Hospital Shatabdi Hospital Shree Nursing Home Surya Chest Foundation Status Not Applicable Health Type Approved 30/04/2009 Yes Date No Date Specified Condition Patients Moderate to severe Asthma Type Details Intervention Fluticasone / Formoterol 125/6 mcg administered through a pressurized metered dose inhaler two puffs twice daily Comparator Agent Budesonide / Formoterol 200/6 mcg administered through a pressurized metered dose page 4 / 7

5 Inclusion Criteria Exclusion Criteria Age From Age To Gender Details Details Year(s) Year(s) Both Inclusion Criteria inhaler, two puffs twice daily 1. Subjects willing to give written informed consent. 2. Subjects of either sex between 18 and 65 years of age. 3. Confirmed diagnosis of asthma according to GINA guidelines. [Subjects demonstrating reversibility (FEV1) of? 12% &?200 ml, 20 minutes post administration of 200?g Levosalbutamol delivered by pressurized metered dose inhaler (pmdi) with spacer. Documented reversibility within the last 6 months is acceptable 4. Subjects with documented history of asthma for at least the past 6 months who are on stable dose of ICS or ICS+LABA for at least 4 weeks prior to runin. 5. FEV1? 40% and 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 and ICS+ LABA combination 12 hours prior to screening visit. 6. Able to use the Peak Flow Meter, pressurized metered dose inhaler (pmdi) with zerostat VT spacer and perform the spirometry as per the study requirement before entering the runin period. 7. In the opinion of the investigator, able to comply with the requirements of the protocol. Exclusion Criteria 1.Known or suspected hypersensitivity to combination or any other constituents of the Investigational Medicinal Product (IMP) & study drugs. 2.Clinical evidence or known history of any serious uncontrolled medical condition [e.g. cardiovascular (high pulse rate, irregular heart beat, high blood pressure), renal, neurological, hepatic, immunological, neoplastic, gastrointestinal, or endocrine disease] or any clinically significant abnormality (e.g. eczema, dermatitis, pneumonia, pulmonary fibrotic disease, active tuberculosis, chronic obstructive pulmonary disease (COPD) or pneumothorax), which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study. 3.Subjects receiving immunotherapy 4.Receipt of any herbal medication 30 day prior to the screening visit 5.Clinically relevant upper respiratory tract infection 4 weeks prior or lower respiratory tract infection 8 weeks prior to the screening visit as judged by investigator. 6.Females who are pregnant, lactating or planning to become pregnant. 7.Women of child bearing potential who are unwilling to take adequate contraceptive precautions unless abstinence is considered adequate in the investigator?s opinion. 8.Clinically significant laboratory values, as judged by the investigator. page 5 / 7

6 Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Prenumbered or coded identical Containers 9.Subjects who have previously been randomized into this study. 10.Receipt of any other clinical trial drug within 30 days prior to study entry (screening visit). 11.Subjects who are scheduled to receive any other investigational drug during the course of the study. 12.Hospitalisation due to exacerbation of asthma within the previous 12 weeks preceding study entry (screening visit). 13.Use of oral or parenteral steroids 4 weeks prior & depot steroid 12 weeks prior to the runin period. 14.Current smoker or past smoker with a smoking history of more than or equal to 10 pack years Participant, Investigator, Outcome Assessor and Dateentry Operator Blinded Primary Outcome Outcome Timepoints Mean change in pre dose morning PEF values recorded over the 12 weeks treatment period.(measured daily, using the Peak Flow Meter) 12 weeks from the baseline visit 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 FEV1 at the end of 2, 4, 8 & 12 weeks Mean change in predose morning PEFR Mean change in predose evening PEFR Proportion of symptomfree days and the proportion of symptom freenights Number of puffs of rescue medication Mean change in Diurnal PEFR variation Total Sample Size=236 Sample Size from =236 07/03/2009 No Date Specified Years=0 Months=9 Days=0 Not Applicable Completed none yet From baseline visit to each treatment visit From baseline visit to each treatment visit From baseline visit to 12 weeks of treatment period From baseline to 12 weeks treatment period From baseline visit to 12 weeks of treatment period From baseline visit to 12 weeks of treatment period This study is a randomized, double blind, active controlled, comparative, parallel group, multicenter study designed to assess the efficacy and safety of Fluticasone / Formoterol 125/6 mcg combination verses Budesonide / Formoterol 200/6 mcg combination administered (two puffs twice daily) though a pressurized Metered Dose Inhaler (pmdi) over 12 week treatment period in subjects with moderate to severe Bronchial Asthma. Total 236 subjects will be enrolled into the study which includes 20 % drop outs. Subjects between 18 to 65 years of age diagnosed with Asthma as per GINA guidelines and subjects willing to sign written informed consent and receiving inhaled page 6 / 7

7 Powered by TCPDF ( PDF of Trial corticosteroids (ICS) / long acting beta 2 agonists or high dose of inhaled steroids are eligible for the study. Duration for this study is 16 weeks.this includes 12 weeks of treatment period and 2 to 4 weeks of run in period. The primary end point of the study is the mean change in pre dose morning PEF values recorded over the 12 weeks treatment period. The secondary endpoints are mean change in FEV1, evening PEFR, symptoms and rescue medication at the end of 2, 4, 8, and 12 weeks of treatment. Adverse events will be evaluated at each visit. page 7 / 7