FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2016/11/007460 [Registered on: 10/11/2016] Trial Registered Prospectively
Last Modified On: 22/10/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Open label study 
Study Design  Other 
Public Title of Study   A prospective, observational study to evaluate effectiveness and safety of fixed dose combination of Indacaterol maleate 110 mcg and Glycopyrronium bromide 50 mcg in stable Chronic Obstructive Pulmonary Disease (COPD) patients  
Scientific Title of Study   A prospective, observational study to evaluate effectiveness and safety of fixed dose combination of Indacaterol maleate 110 mcg and Glycopyrronium bromide 50 mcg in stable Chronic Obstructive Pulmonary Disease (COPD) patients  
Trial Acronym  Ultibro Study 
Secondary IDs if Any  
Secondary ID  Identifier 
CQVA149AIN01, Version 00 dated 07 May 2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Pallavi Kawatra 
Designation  Medical Advisor 
Affiliation  Novartis Healthcare Pvt Ltd 
Address  Novartis Healthcare Pvt. Ltd., 6th & 7th Floor, Inspire BKC G Block BKC Mumbai 400051 INDIA

Mumbai
MAHARASHTRA
400051
India 
Phone  50243596  
Fax    
Email  pallavi.kawatra@novartis.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Pallavi Kawatra 
Designation  Medical Advisor 
Affiliation  Novartis Healthcare Pvt Ltd 
Address  Novartis Healthcare Pvt. Ltd., 6th & 7th Floor, Inspire BKC G Block BKC Mumbai 400051 INDIA

Mumbai
MAHARASHTRA
400051
India 
Phone  50243354  
Fax    
Email  pallavi.kawatra@novartis.com  
 
Source of Monetary or Material Support  
Novartis Healthcare private limited 
 
Primary Sponsor  
Name  Novartis Healthcare private limited 
Address  Sandoz House, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai 400 018. INDIA. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 33  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sudhir Prasad  Aware Global Hospitals  Aware Global Hospitals, 08-16-01, Sagar X Roads, L.B Nagar, Hyderabad 500035, India.
Hyderabad
ANDHRA PRADESH 		 914024111111

drsudhirprasad@gmail.com 
Dr Randeep Guleria  All India Institute of Medical Science  Department of Pulmonary Medicine & Sleep Disorders, All India Institute of Medical Sciences, Ansari Nagar, New Delhi- 110029, India
New Delhi
DELHI 		 919810184738

randeepguleria2002@yahoo.com 
Dr Sushmita RoyChowdhury  Apollo Gleneagles Hospital  Apollo Gleneagles Hospital, 58 Canal Circular Road, Kolkata 700054, West Bengal, India
Kolkata
WEST BENGAL 		 919836967500

sushmita.rc@gmail.com 
DrRVijai Kumar  Apollo Hospitals  Jubilee Hills, Hyderabad, Telangana, India- 500096
Hyderabad
ANDHRA PRADESH 		 9949809444

drvijaipulmo@yahoo.co.in 
Dr Kashmira Jhala  Apollo Hospitals Enterprise Limited  Apollo Hospitals International Limited, Plot no1 A, Bhat GIDC Estate, Gandhinagar-382428, Gujarat India
Gandhinagar
GUJARAT 		 917966701876

drkashmirajhala@yahoo.co.in 
Dr Himanshu Garg  Artemis Hospital  Artemis Hospital,Sector -51, Gurgaon, Haryana 122001, India.
Gurgaon
HARYANA 		 919717156157

himanshug@artemishospitals.com 
Dr P C Kathuria  B.L.K Super Speciality Hospital  Pusa Road, Karol Bagh, New Delhi, Delhi -110005, India
New Delhi
DELHI 		 919312285947

pc_kathuria@yahoo.com 
Dr Vishwanath Bellad  BGS Global Hospitals  BGS Global Hospitals, #67, Uttarahalli Main Road, Kengeri, Bangalore 560060, Karnataka, India.
Bangalore
KARNATAKA 		 918030444192

vishwanath_b@yahoo.com 
DrHirenappa Udnur  Columbia Asia Hospital-Hebbal  Columbia Asia Hospital - Hebbal, Kirloskar Business Park, Bellary Road, Hebbal, Bengaluru, Karnataka 560024, India
Bangalore
KARNATAKA 		 918041791000

hudnur@yahoo.com 
Dr Pradyut Wagharey  Eesha Hopsital  Plot no. 6-3-1106/1/A. adjacent to HSBC bank, Rajbhawan road, Somajiguda, Hyderabad, Telangana 500082
Hyderabad
ANDHRA PRADESH 		 919246531036

pradyut_waghray@rediffmail.com 
Dr Ravi Shekhar Jha  Fortis Escorts Hospital  Fortis Escorts Hospital , Neelam Bata Road, Faridabad 121001, Haryana, India.
Faridabad
HARYANA 		 919810963703

shekharravi15@gmail.com 
Dr Vivek Nangia  Fortis Flt. Lt. Rajan Dhall Hospital  Fortis Flt. Lt. Rajan Dhall Hospital, Sector B, Pocket 1, Aruna Asaf Ali Marg, Vasant Kunj, New Delhi 110070,India.
New Delhi
DELHI 		 919810048885

vivek.nangia@fortishalthcare.com 
Dr Ashok Rajput  Fortis Hopital  A-146 Lok Vihar, Pitampura, Delhi-110034
North West
DELHI 		 919717785723

rajput.chest@gmail.com 
Dr Amit Kumar Mandal  Fortis Hospital  Fortis healthcare sector 62 phaseVIII Mohali Punjab-160062
Rupnagar
PUNJAB 		 919779901068

dramitkrmandal@yahoo.co.in 
Dr Raja Dhar  Fortis Hospital  Fortis Hospital, 730 Anandapur, Kolkata, West Bengal 700107, India
Kolkata
WEST BENGAL 		 919831855512

docaardee@yahoo.com 
DrVijil Rahulan  Global Health City  Global Health City 439,Cheran Nagar,Perumbakkam,Chennai-600100, Tamilnadu
Chennai
TAMIL NADU 		 919445060066

vkrahulan@gmail.com 
Dr Tapaswi Krishna  Global Hospital  Global Hospitals, #6-1-1070/1 to 4, Lakdikapool, Hyderabad 500004, India.
Hyderabad
ANDHRA PRADESH 		 919490935455

drtapaswikrishna@gmail.com 
Dr Ashok Anant Mahashur  Hinduja Hospital  P.D. Hinduja Hospital, Veer Savarkar Marg, Mahim, Mumbai-400 016 India
Mumbai
MAHARASHTRA 		 919821231238

mahashuraa@hotmail.com 
Dr Satya Prakash Rai  Kokilaben Dhirubhai Ambani Hospital &   Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute, Rao Saheb Achutrao, Patwardhan Marg, Four Bunglows, Andheri (W), Mumbai, Maharashtra 400053, India
Mumbai
MAHARASHTRA 		 917498226856

Sp.Rai@relianceada.com 
DrRamana Prasad V Velamuru  Krishna Institute of Medical Sciences   Krishna Institute of Medical Sciences, 1-8-31/1, Minister Road, Secunderabad-500003, Andhra Pradesh
Hyderabad
ANDHRA PRADESH 		 919849991393

ramanaprasadpulmo@gmail.com 
Dr Minesh Patel  Krishna Shalby Hospital  Krishna Shalby Hospital 319-Green city Ghuma Via Bopal Ahmedabad 380058 Gujarat India
Ahmadabad
GUJARAT 		 919879119764
917940203115
mineshmanshu@yahoo.com 
Dr Ranganatha R  Mazumdarshaw Medical Centre (Unit of Narayan Health)  258/A, Bommasandra Industrial Area, Anekal, Bangalore, India
Bangalore
KARNATAKA 		 919740200774

drrr_74@yahoo.com 
Dr Ashish Goyal  Medipont Hospital  Medipoint Hospital,New DP road,Aundh,Pune411007
Pune
MAHARASHTRA 		 917743871226

drashishgoyal1111@gmail.com 
Dr Bhanu Pratap Singh  Midland Health Care & Research Center  Midland Health Care and Research Center, B-55 and C-42, Mandir Marg, Mahanagar Extn., Lucknow-2260006, U.P. India
Lucknow
UTTAR PRADESH 		 919415011669

bps2159@yahoo.com 
Dr Arunesh Kumar  Paras Hospital  Paras Hospital, C-1, Sushant Lok, Phase 1, Sector -43, Gurgaon, Haryana 122002, India.
Gurgaon
HARYANA 		 918340389940

drarunesh.kumar@parashospitals.com 
Dr RMPL Ramanathan   PSG Hospitals  PSG Hospitals, Avinashi Road, Peelamedu, Coimbatore – 641004, Tamil Nadu, INDIA
Coimbatore
TAMIL NADU 		 919894759917

ramanathanstudy@gmail.com 
Dr Tejas Kakkad  Rhythm Heart Institute  Rhythm Heart Institute Near Siddharth Bunglows Sama Savli Road Vadodara22 Gujarat
Vadodara
GUJARAT 		 919925207953

drtejascr@gmail.com 
Dr Mahavir Modi  Ruby Hall Clinic  40, 16th Sassoon Road, Agarkar Nagar, Pune, Maharashtra 411001, India
Pune
MAHARASHTRA 		 919822253596

drm_modi@yahoo.co.in 
Dr Harendra Thakker  Shalby Hospital  Shalby Hospital, Opp. Karnavati Club, S G Road, Ahmedabad - 380015, Gujarat, India
Ahmadabad
GUJARAT 		 917940203148

research1@shalby.org 
Dr Animesh Arya  Sri Balaji Action hospital  A-4 Paschim Vihar New Delhi-110063, India
New Delhi
DELHI 		 919810350355

dranimesharya@gmail.com 
Dr T Dhanasekar  Sri Ramachandran Medical Centre  No.1, Ramachandra Nagar, Porur,Chennai-600116,Tamil Nadu, India
Chennai
TAMIL NADU 		 919443037627

drdhansekar@yahoo.com 
Dr Pawan Agarwal  The Calcutta Medical Research Institute  The Calcutta Medical Research Institute, 7/2 Diamond Harbour Road, Kolkata 700023, West Bengal, India
Kolkata
WEST BENGAL 		 919830080002

dr.pawanagarwal@gmail.com 
Dr K Satish  Vikram Hospital  Vikram Hospital(bengaluru) pvt ltd. #71/1 millers road, opp st.annes college Bengaluru- 560052
Bangalore
KARNATAKA 		 08071003601

mamthasatish@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 33  
Name of Committee  Approval Status 
All India Institute of Medical Sciences  Submittted/Under Review 
Artemis Health Sciences Institutional Ethics Committee  Approved 
Dr. B.L.Kapur Memorial Hospital Ethics Committee  Submittted/Under Review 
Eesha Ethics Committee  Approved 
Ethics Committee Apollo Hospitals International LTD  Approved 
Ethics Committee For Research Fortis Flt. Lt. Rajan Dhall Hospital   Submittted/Under Review 
Ethics Committee Fortis Hospital Delhi  Submittted/Under Review 
Ethics Committee SHALBY LIMITED  Approved 
ETHICS Committee Shalby limited  Approved 
INSTITUTIONAL ETHICS COMMITTEE Aware Global Hospital  Approved 
INSTITUTIONAL ETHICS COMMITTEE BGS Hospitals  Approved 
INSTITUTIONAL ETHICS COMMITTEE COLUMBIA ASIA HOSPITALS  Approved 
Institutional Ethics Committee Fortis Escorts Hospital   Approved 
Institutional Ethics Committee Fortis Hospital , Kolkata  Approved 
Institutional Ethics Committee Fortis Hospital, Punjab  Submittted/Under Review 
Institutional Ethics Committee Global Health City  Approved 
Institutional Ethics Committee Global Hospitals, Hyderabad  Approved 
Institutional Ethics Committee, Sri Ramachandra University  Submittted/Under Review 
Institutional Ethics Committee, P.D. Hinduja National Hospital & Medical Research Centre  Submittted/Under Review 
Institutional Ethics Committee, Apollo Gleneagles Hospital  Approved 
Institutional Ethics Committee, Poona Medical Research Foundation Pune  Approved 
Institutional Ethics Committee, The Calcutta Medical Research Institute  Approved 
Institutional Ethics committee- Clinical Studies(IEC-CS)  Approved 
Institutional Etics Committee, Midland health Care and Research Center  Approved 
Institutional Human Ethics Committee, PSG Hospital  Approved 
Institutional Scientific and Ethics Board  Approved 
KFRC AND ETHICS COMMITTEE  Approved 
Narayan Health Medical Ethics Committee  Submittted/Under Review 
Paras Hospital Ethics Committe  Approved 
Pentamed Ethics Committee  Approved 
Rhythm Heart Institute Ethics Committee  Approved 
Sri Balaji Action Medical Institute Ethics Committee  Submittted/Under Review 
Vikram Hospital Ethics Committee Bengaluru PVT LTD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Obstructive Pulmonary Disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. COPD patients prescribed with FDC of Indacaterol maleate 110 mcg + Glycopyrronium bromide 50 mcg as per discretion of treating physician and as per product prescribing information.
2. Patients willing to participate in the study by providing written informed consent. 
 
ExclusionCriteria 
Details  1. Contraindication as per PI
2. Patients simultaneously participating in other studies or use of other investigational drug at the time of enrollment or 5 times the half life of the investigational product prior to visit 1.
Pregnant women should not be included except if, in the opinion of the investigator, the expected benefit outweighs the potential risk to the fetus (please see Section 11 for further information). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To obtain effectiveness data in patients treated with FDC of Indacaterol maleate 110 mcg + Glycopyrronium bromide 50 mcg in terms of trough FEV1 following 26 weeks of treatment in patients with COPD.  26 weeks of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in trough pre-dose FEV1 from baseline to week 8, 16 and 26  26 weeks of treatment 
Assessing Safety   26 weeks of treatment 
Rate of exacerbation to gain real world experience  26 weeks of treatment 
 
Target Sample Size
Modification(s)  		 Total Sample Size="428"
Sample Size from India="428" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)
Modification(s)  		 14/12/2016 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Study design

This is an open-label, multicenter, prospective, observational study to evaluate, effectiveness and safety of FDC of Indacaterol maleate 110 mcg + Glycopyrronium bromide 50 mcg prescribed in patients of COPD as per discretion of treating physician. The prescription decision shall be independent of decision for inclusion in the study. Patients treated according to local routine clinical practice will be enrolled in the study upon signing an Informed Consent. Eligibility for study entry will be determined by the study investigator, in accordance with the selection criteria below. Signing of the Informed Consent defines the study entry visit. 
Close