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Example 001
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REF/2011/11/002944CTRI Website URL - http://ctri.nic.in
Clinical Trial Details (PDF Generation Date :- Mon, 05 Aug 2013 10:01:00 GMT)
CTRI Number CTRI/2011/11/002161 [Registered on: 23/11/2011] - Trial Registered Prospectively
Last Modified On 31/12/2012
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Drug
Study Design Randomized, Parallel Group, Active Controlled Trial
Public Title of Study A clinical trial to study the effects of Salmeterol/Fluticasone in patients with Persistent Asthma.
Scientific Title ofStudy
A Phase III, Randomized, Open Label, Non- Inferiority, Comparative, Multicentric Study BetweenHFA-Propelled Salmeterol/Fluticasone (25/250?g) pMDI And HFA-Propelled Seretide® (25/250?g)pMDI In Patients With Persistent Asthma
Secondary IDs if Any Secondary ID Identifier
GL-SF/2011-12 Protocol Number
Details of PrincipalInvestigator or overallTrial Coordinator(multi-center study)
Details of Principal Investigator
Name
Designation
Affiliation
Address
Phone
Fax
Details ContactPerson (ScientificQuery)
Details Contact Person (Scientific Query)
Name Dr Anil Avhad
Designation Sr. Manager - Medical Services
Affiliation Glenmark Pharmaceuticals Ltd
Address Glenmark Pharmaceuticals Ltd Glenmark House, BD Sawant Marg,Chakala Andheri EastMumbaiMAHARASHTRA400099India
Phone 2240189999
Fax
Email [email protected]
Details ContactPerson (Public Query)
Details Contact Person (Public Query)
Name Dr Shailendra Sachan
Designation Manager-Clinical Research
Affiliation Glenmark Pharmaceuticals Ltd
Address Glenmark Pharmaceuticals Ltd Glenmark Research Centre, Plot No.A-607, T.T.C. Industrial Area, MIDC, MahapeThaneMAHARASHTRA400709India
Phone 02267720000
Fax
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REF/2011/11/002944CTRI Website URL - http://ctri.nic.in
Email [email protected]
Source of Monetary orMaterial Support
Source of Monetary or Material Support
> Glenmark Pharmaceuticals Ltd.
Primary Sponsor Primary Sponsor Details
Name Glenmark Pharmaceuticals Ltd
Address Glenmark Pharmaceuticals Ltd Glenmark House, B D Sawant MargChakala, Andheri(East), Mumbai, India-400099
Type of Sponsor Pharmaceutical industry-Indian
Details of SecondarySponsor
Name Address
NIL NIL
Countries ofRecruitment
List of Countries
India
Sites of Study Name of PrincipalInvestigator
Name of Site Site Address Phone/Fax/Email
Dr Animesh Arya Centre for ChestDiseases, Allergy &Sleep Disorder
B-3/17, Paschim Vihar,Near Jwala Heri MarketNew DelhiDELHI
011-25269552
Dr Sachin V Yadav Chintamani Hospital 53-Tedghe Nagar,BikewewadiPuneMAHARASHTRA
9370250050
Dr S Nagarajan Coimbatore ChestClinic
M.S.S MemorialBuilding.No.8, D .BRoad, R S PuramCoimbatoreTAMIL NADU
0422-2557415
Dr Shivakumar BR Cosmopolitan MedicalCenter
Department of Clinicalresearch, No.8, 5 Main,Mariappa Road,(Kullappa Circle),Kammanahalli,St.Thomas Town PostBangaloreKARNATAKA
80-25790735
Dr Deepak Namjoshi Criticare MultispecialtyHospital and ResearchCenter
Plot No.39,Opp, CopperChimney, Opp.JuhuSupreme ShoppingCenter, Main GulmoharRoad, JVPD Scheme,Andheri (W)MumbaiMAHARASHTRA
9820127184
Dr Mukesh Jain Dr. Mukesh Jain’sClinic
70/70 Madhyam Marg.ManasarovarJaipurRAJASTHAN
0141-2783471
Dr Deepak Yaduvanshi Fortis Escorts Hospital Department ofRespiratory and CriticalCare Medicine, FortisEscort Hospital, JLNMarg, Malviya NagarJaipurRAJASTHAN
0141-2547000
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REF/2011/11/002944CTRI Website URL - http://ctri.nic.in
Dr Ramesh Bhoite Giriraj Hospital Indapur Road, Near STStand, BaramatiPuneMAHARASHTRA
9822217147
Dr Rahul Patil Jeevanrekha Hospital Behind Ved Mandir,Tidke Colony, TrimbakRoad,NashikMAHARASHTRA
9922420180
Dr Nalini Nagalla KIMS (Krishna Instituteof Medical Sciences)
Department ofPulmonology, 1-8-31/1,Minister Road,SecunderabadHyderabadANDHRA PRADESH
040-27814910
Dr Ravindra Sarnaik Leela More Chest Clinic 57 North Avenue,DhantoliNagpurMAHARASHTRA
0712-436384
Dr Sangita JayantPednekar
Lokmanya TilakMedical Hospital
Department ofMedicine, LokmanyaTilak Municipal MedicalCollege & GeneralHospital, SionMumbaiMAHARASHTRA
9821577430
Dr Sandeep Gupta M.V. Hospital andResearch Center
Mirza mandi Chowk,LucknowUTTAR PRADESH
8400388966
Dr Ashish Goyal Medipoint HospitalsPvt. Ltd
241/ 1 New D.P.RoadAundh,PuneMAHARASHTRA
9372433824
Dr Mahavir Modi Modi Clinic Dhankawdi Post Office,Balaji NagarPuneMAHARASHTRA
9822253596
Dr Manish Jain Navkar Hospital G-11,ShubhamApartment , CentralSpine, VidhyadharNagarJaipurRAJASTHAN
0141-2338257
Dr Yogeesha KS Omega Hospital Department of GeneralMedicine, MahaveerCircle, KankanadyDakshina KannadaKARNATAKA
0824-2431188
Dr Shrikant Papinwar Papinwar Hospital Papinwar Hospital, 57Mahesh Nagar, Opp.SFS, Besides KabraHospital, Jalna RoadAurangabadMAHARASHTRA
9822344355
Dr Sameer Chandrarte ShatabdiSuperspeciality Hospital
Suyojit City Centre,Opposite MahamargBus Stand, Mumbai
9823058495
sameer.chandratre@g
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REF/2011/11/002944CTRI Website URL - http://ctri.nic.in
NakaNashikMAHARASHTRA
mail.com
Dr VijayalakshmiThanasekaraan
Sri RamachadraMedical College(SRMC)
Department ofPulmonology SriRamachadra MedicalCollege and ResearchInstitute (SRMC) No.1Ramachandra NagarChennaiTAMIL NADU
044-24765632
Dr T Mohan Kumar Sri RamakrishnaHospital, Institute ofPulmonary Medicine
No. 395 Sarojini NaiduRoad AvarampalamRoadCoimbatoreTAMIL NADU
9894622018
Dr Pravin Supe Supe Hospital Instituteof Excellence inDiabetes & Obesity
In front ofAdharashram,Gharpure ghat, NearRunghta Highschool,Ashok Stambha,NashikMAHARASHTRA
9405366165
Dr Vivek Gupta Suretech Hospital &Research CentreLimited
Department ofPulmonary Medicine,13 A, R.P. BanerjeeMarg, DhantoliNagpurMAHARASHTRA
0712-6636816
Dr Bhanu Pratap Singh Surya ChestFoundation C/O AdityaClinic
#16/1326, Indira NagarMunshi PuliaLucknowUTTAR PRADESH
05226535828
Dr Ashish Tondon Tandon Chest andSleep Centre
17 A/3 Patrika Marg,Civil LineAllahabadUTTAR PRADESH
9415214339
Dr Shilpa Karande TN Medical college,BYL Nair hospital
Department ofMedicine, 1st Floor,Room no.104, CollegeBuilding, T.N.MedicalCollege & BYL NairCharitable Hospital Dr.A. L. Nair Road.Mumbai Central (E)MumbaiMAHARASHTRA
9819854135
Dr Ravindra Sanglikar Vedant multispecialtyhospital and researchcentre
S3, 2nd, VedantComplex, Vartak Nagar,Thane (w)ThaneMAHARASHTRA
9892078562
Dr Hansraj Alva Vinaya Hospital &Research Centre ( Aunit of KarnatakaInstitute of MedicalSciences)
PO Box No. 717,KarangalpadyDakshina KannadaKARNATAKA
0824-4243555
Dr Agam Vora Vora Clinic 302, Soni Shopping 022-28891484
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REF/2011/11/002944CTRI Website URL - http://ctri.nic.in
Centre, L.T.Road,Borivali (west)MumbaiMAHARASHTRA
Details of EthicsCommittee
Name of Committee Approval Status Date of Approval Is Independent EthicsCommittee?
Bangalore CentralEthics Committee, Bangalore_CosmopolitanMedical Center
Approved 18/08/2011 Yes
Canara ResearchEthical Committee,Mangalore_OmegaHospital
Approved 21/09/2011 Yes
Canara ResearchEthical Committee,Mangalore_VinayaHospital & ResearchCentre ( A unit ofKarnataka Institute ofMedical Sciences)
Approved 21/09/2011 Yes
ConscienceProfessional EthicsCommittee,Aurangabad_PapinwarHospital
Submittted/UnderReview
No Date Specified Yes
Cosmos IndependentEthics committee,Mumbai_Vedantmultispecialty hospitaland research centre
Approved 11/02/2012 Yes
Ethics Committee,Breathe Trust,Nagpur_Leela MoreChest Clinic
Approved 15/07/2011 No
Excel Society ofMedical SciencesIndependent EthicsCommittee,Mumbai_CriticareMultispecialty Hospitaland Research Center
Approved 12/07/2011 Yes
Excel Society ofMedical SciencesIndependent EthicsCommittee,Mumbai_SriRamakrishna Hospital
Approved 24/08/2011 Yes
Excel Society ofMedical SciencesIndependent EthicsCommittee,Mumbai_Tandon Chestand sleep Centre
Approved 12/07/2011 Yes
Global Health ConcernEthics Committee,Nagpur_SuretechHospital & Research
Approved 27/09/2011 Yes
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REF/2011/11/002944CTRI Website URL - http://ctri.nic.in
Centre Limited
GRACE (Group forResearch Advancementin Clinical Ethics), NewDelhi_Centre for ChestDiseases, Allergy &Sleep Disorder
Approved 12/10/2011 Yes
Independent EthicsCommittee,Lucknow_Surya ChestFoubndation
Approved 31/10/2011 Yes
Institutional EthicsCommittee,Chennai_SriRamachandraUniversity
Approved 08/08/2011 No
Institutional EthicsCommittee, Coimbatore_Coimbatore ChestClinic
Approved 12/08/2011 No
Institutional EthicsCommittee,Hyderabad_KrishnaInstitute of MedicalSciences
Approved 17/10/2011 No
Institutional EthicsCommittee,Jaipur_Fortis EscortsHospital
Approved 15/09/2011 No
Institutional EthicsCommittee, Mumbai –Human Research Staff& Society_LokmanyaTilak Medical Hospital
Submittted/UnderReview
No Date Specified No
Institutional EthicsCommittee,Mumbai_BYL Nair Ch.Hospital & TN MedicalCollege
Submittted/UnderReview
No Date Specified No
Institutional EthicsCommittee_Lucknow_M.V. Hospital andResearch Center
Approved 28/03/2012 No
Lancelot IndependentEthics Committee,Mumbai_Vora Clinic
Submittted/UnderReview
No Date Specified Yes
Magna Care EthicsCommittee_Nasik_Supe Hospital Instituteof Excellence inDiabetes & Obesity
Approved 02/03/2012 Yes
Magna Care Ethics Committee_Nasik_Jeevanrekha Hospital
Approved 18/02/2012 Yes
Mahalsa IndependentEthics Committee,Pune_ChintamaniHospital
Approved 12/08/2011 Yes
page 6 / 9
REF/2011/11/002944CTRI Website URL - http://ctri.nic.in
Mahalsa IndependentEthics Committee,Pune_Giriraj Hospital
Approved 12/08/2011 Yes
Mahalsa IndependentEthics Committee,Pune_Modi Clinic
Approved 12/08/2011 Yes
Penta-Med EthicsCommittee,Pune_MedipointHospitals Pvt. Ltd
Approved 29/02/2012 Yes
Sanjeevani EthicsCommittee,Jaipur_Navkar Hospital
Approved 03/08/2011 Yes
Shatabdi HospitalEthics Committee,Nashik
Submittted/UnderReview
No Date Specified No
Swasthya Kalyan EthicsCommittee, Jaipur_Dr.Mukesh Jain’s Clinic
Approved 12/10/2011 Yes
Regulatory ClearanceStatus from DCGI
Status Date
Approved/Obtained 15/09/2011
Health Condition /Problems Studied
Health Type Condition
Patients Persistent Asthma
Intervention /Comparator Agent
Type Name Details
Intervention Salmeterol/Fluticasone 2 puffs twice daily for 12 weeks
Comparator Agent Seretide® 2 puffs twice daily for 12 weeks
Inclusion Criteria Inclusion Criteria
Age From 12.00 Year(s)
Age To 65.00 Year(s)
Gender Both
Details 1. The patient provides written informed consent to participate in thestudy2. Male or female patient aged ?12 years3. Documented diagnosis of asthma4. FEV1 between 50% and 80% of the predicted value5. Patient willing to perform all study related procedures including theuse of study inhalers, spirometer and peak flow meter.6. Female participants must have a negative pregnancy test atscreening visit and willing to use acceptable contraceptive measuresduring the study. Males must agree to use barrier contraceptionwhile on study medication and for 90 days after taking the last doseof study medication.
Exclusion Criteria Exclusion Criteria
Details 1. Patient with Chronic Obstructive Pulmonary Disease (COPD)2. Pregnant or lactating women3. Patients with a history of hypersensitivity toSalmeterol/Fluticasone and/or any other ingredients4. History of Asthma exacerbation and hospitalization needed due toasthma within the last 3 months prior to the study5. Patients diagnosed with Intermittent, seasonal or exercise InducedAsthma6. Patients with active smoking7. Subjects who are using any medication or has any disease whichin the judgment of the investigator will interfere with the conduct or
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REF/2011/11/002944CTRI Website URL - http://ctri.nic.in
interpretation of the study8. Clinically significant cardiovascular, haematological, endocrine,neurological, gastrointestinal, psychiatric, metabolic, immunologic,infectious, hepatic, renal, gynaecological disease or other conditionthat the investigator considers detrimental to the patient’sparticipation in the study or that may prevent the successfulcompletion of the study9. Clinically significant ECG Abnormality at baseline10. Patients with documented or suspected or current history ofalcohol and drug abuse11. Patients who have undergone major surgery in the previous 4weeks12. Participation in an investigational drug trial within 3 months ofscreening
Method of GeneratingRandom Sequence
Stratified block randomization
Method ofConcealment
Centralized
Blinding/Masking Open Label
Primary Outcome Outcome Timepoints
The mean difference between groups in ForcedExpiratory Volume in 1 second (FEV1) value atthe End of Treatment Visit
12 weeks
Secondary Outcome Outcome Timepoints
Change over the weeks in morning PEF 12 weeks
Change over the weeks in evening PEF 12 weeks
Change in asthma symptom score 12 weeks
Change in nocturnal asthma symptom score 12 weeks
Investigator global impression 12 weeks
Patient global impression 12 weeks
Target Sample Size Total Sample Size=372Sample Size from India=372
Phase of Trial Phase 3
Date of FirstEnrollment (India)
01/12/2011
Date of FirstEnrollment (Global)
No Date Specified
Estimated Duration ofTrial
Years=0Months=9Days=0
Recruitment Status ofTrial (Global)
Not Applicable
Recruitment Status ofTrial (India)
Completed
Publication Details
Brief Summary This is a randomized, open–label, comparative, non-Inferiority,
multicenteric study. The study will be conducted in patients with a diagnosis of
persistent asthma with an FEV1 of 50% to 80% of the predicted value. Study will
enroll 372 patients across different centers from India.
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REF/2011/11/002944CTRI Website URL - http://ctri.nic.in
Patients will be recruited after providing written informed consent. After screening
and run in period, patient will be randomized (patient meeting randomization
criteria) in 1:1 ratio to receive either HFA-Propelled Salmeterol/Fluticasone pMDI
or HFA Propelled Seretide® pMDI.
The primary objective of the study is to evaluate the effect of study drug on lungfunction as assessed by FEV1 after the therapy (12 weeks). Secondary objectiveincludes Change in PEF, asthma symptoms, patient / investigator’s globalassessments and safety. Patients will be followed for safety and efficacyassessment at week 4, 8 and 12 after start of therapy.
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