| CTRI Number |
CTRI/2010/091/000665 [Registered on: 29/07/2010] |
| Last Modified On: |
07/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Effect of QVA149 Versus NVA237 on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations |
Scientific Title of Study
Modification(s)
|
A 52-week treatment, multi-center, randomized, double-blind, parallel-group,active controlled study to evaluate the effect of QVA149 (110/50 microgram o.d.) vs NVA237 (50 microgram o.d.) and open-label tiotropium (18 microgram o.d.) on COPD
exacerbations in patients with severe to very severe chronic obstructive pulmonary disease (COPD) |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CQVA149A2304; Version:3; dated:09-Sep-2010 |
Protocol Number |
| NCT01120691 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Murugananthan K |
| Designation |
Head-Clinical Development |
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Murugananthan K |
| Designation |
|
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Murugananthan K |
| Designation |
Head-Clinical Department |
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Novartis Pharma AG, Basel, Switzerland |
|
Primary Sponsor
Modification(s)
|
| Name |
Novartis Healthcare Pvt Ltd |
| Address |
Medical Dept,Sandoz House, Shiv Sagar Estate,Dr.Annie Besant Rd, Worli Mumbai-400018 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
Austria
Brazil
Canada
Colombia
Czech Republic
Denmark
Estonia
Finland
Germany
Greece
Guatemala
Hungary
India
Israel
Italy
Netherlands
Norway
Philippines
Poland
Russian Federation
Slovakia
Spain
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Vallandramam Ranganathan Pattabhiraman |
Kovai Medical Centre & Hospital (KMCH) |
Respiratory Dept,,P.O.Box 3209, Avinashi Road- 641 014
Coimbatore
TAMIL NADU |
0422-2625080
0422-2625080
vr.pattabhiraman@gmail.com |
| Dr. Mahesh Padukudru Anand |
Allergy, Asthma & Chest Centre |
1397, 4th Cross, Krishnamurthypuram,,-570004
Mysore
KARNATAKA |
0821-2432543
00-821-2331290
dr_maheshpa@yahoo.com |
| Dr. Sundeep Salvi |
Chest Research Foundation |
Marigold, Kalyani Nagar,-411 014
Pune
MAHARASHTRA |
020-27035361
020-27035371
ssalvi@crfindia.com |
| Dr. Srinivasan Nagarajan |
Coimbatore Chest Clinic |
M.S.S Memorial Building, Opp. Savita Hall, ,No.8, D.B. Road, R.S. Puram,-641002
Coimbatore
TAMIL NADU |
00-91-422-2557415
00-91-422-2557415
nagrajsri@gmail.com |
| Dr. Rajesh Swarnakar |
Get Well Hospital & Research Institute |
plot no. 20/1, Dr. Khare Marg,Dhantoli,-440012
Nagpur
MAHARASHTRA |
00-91-9822225130
00-91-712-2461249
rajeshswarnakar@yahoo.co.in |
| Dr. Salil Bhargava |
Gyanpushp Research Centre for Chest & Allergy Diseases, |
"Surabhi", 76, Dhar Kothi, ,Residency Area-452 001
Indore
MADHYA PRADESH |
0731-2711271
0731-2711623
bhargavasalil@hotmail.com |
| Dr. Rajendran Nair |
Health and Research Centre |
1/907, Devi Scans Building, Kumarapuram,Medical College P.O.-695011
|
00-91-471-2447575
00-91-471-2446460
rajendranammu@yahoo.com |
| Dr. Parthasarthy Bhattacharya |
Institute of Pulmocare and Research |
CB-16 Salt Lake,-700064
Kolkata
WEST BENGAL |
00-91-33-23580424
00-91-33-23580424
parthachest@yahoo.com |
| Dr. Pradyut Waghray |
Kunal Institute of Medical Specialities Pvt Ltd |
5-9-41/1/A, New MLA Quarters Lane,Basheer Bagh-500029
Hyderabad
ANDHRA PRADESH |
040-23236243
040-23236243
kimschest@rediffmail.com |
| Dr. Srikanth Krishnamurthy |
PSG Hospital, Professor & Head of TB & Respiratory Diseases |
PSG Hospital, Avinashi Road,,Peelamedu, -641004
Coimbatore
TAMIL NADU |
00-91-40-2575262
00-91-422-2573556
drsrikanthcbe@gmail.com |
| Dr. Sandeep Saboo |
Saboo Hospital |
14-7-25, Begum Bazzar ,-500 001
Hyderabad
ANDHRA PRADESH |
040-24600896
040-24651296
deep5870@gmail.com |
| Dr. Sameer Chandratre |
Shatabdi Hospital, |
Suyojit City Centre,,Opp. Mahamarg Bus Stand, Mumbai Naka-422005
Nashik
MAHARASHTRA |
(0253) 2501999
00-91-253-2502105
sameer.chandratre@gmail.com |
| Dr. Virendra Singh |
SMS Hospital, |
Allergy Pulmonary Medicine,,Dhanvantari OPD Block,-302 004
Jaipur
RAJASTHAN |
00-91-141-2560800
00-91-141-2560800
drvirendrasingh@yahoo.com |
| Dr Anthony Mesquita |
TB & Chest Hospital |
St. Inez,PO Caranzalem, Panjim-403 002
South Goa
GOA |
00918322225007
mesquita@sancharnet.in |
| Dr. J.C. Suri |
Vardhman Mahavir Medical College & Safdarjung Hospital |
Critical Care & Sleep Medicine, Ring Road,,Near AIIMS, Safdarjung Enclave,-110029
New Delhi
DELHI |
00-91-11-26190958
00-91-11-26190958
jcsuri@rediffmail.com |
| Dr. Ratnavelu Vijai Kumar |
Yashoda Hospital, |
Alexander Road,,- 500 003
|
00-040-27610645
91-40-27610645
marluganagadhar@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 17 |
| Name of Committee |
Approval Status |
| CEREBRAL INDEPEDENT REVIEW BOARD, Hyderabad,Dr. Pradyut Wahgrey |
Approved |
| Cerebral Independent Review Board, Hyderabad, Dr. Sandeep Saboo |
Approved |
| Ethical Committee, VMMC & Safdarjang Hospital, New Delhi |
Approved |
| Ethics committee of Diabetes Thyroid Hormone Research Institute Pvt.Ltd, Indore |
Approved |
| Ethics Committee of SMS medical College and Hospital, Jaipur |
Approved |
| Ethics Committee, Allergy Asthma Associates, Mysore |
Approved |
| Independent Ethics Committee, Hyderabad |
Submittted/Under Review |
| Independent Ethics Committee, Nagpur, Dr. Sundeep Salvi |
Approved |
| Independent Ethics Committee, Nagpur, Dr. Swarnakar |
Approved |
| Independent Human Ethics Committee, Health & research Centre,Trivandrum |
Approved |
| Instituitional Ethics Committee, Coimbatore Chest Clinic, Coimbatore |
Approved |
| Institute of Pulmocare & Research, Kolkata |
Submittted/Under Review |
| Institutional Ethics Committee, Yashoda Group Of Hospitals, Secunderabad |
Approved |
| Institutional Ethics Committte, Goa Medical College, Goa |
Approved |
| Institutional Human Ethics Committee, PSG Institute of Medical Sciences and Research, Coimbatore |
Approved |
| KMCH Ethics Committee, Coimbatore |
Approved |
| Shatabdi Hospital Ethics Committee, Nashik |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Chronic Obstructive Pulmonary Disease, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
NVA237: Active Comparator |
50 ìg once daily delivered via a single-dose dry powder inhaler (SDDPI) once-daily NVA237 throughout the study. |
| Intervention |
QVA149: Experimental |
110/50 ìg delivered via a single-dose dry powder inhaler (SDDPI),
consisting of a fixed dose combination of QAB149 110 ìg and NVA237 50 ìg once daily throughout the study. |
| Comparator Agent |
tiotropium |
18 ìg once daily, delivered via the manufacturer’s proprietary inhalation device (Handihaler®) throughout the study. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male or female adults aged greater than or equal to 40 yrs
Severe or very COPD [Stage III or IV as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008]
Smoking history of at least 10 pack years
Post-bronchodilator FEV1 less than 50 percent of the predicted normal value and post- bronchodilator FEV1 or FVC less than 70percent
Documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and or antibiotics
|
|
| ExclusionCriteria |
| Details |
Patients requiring long term oxygen therapy (greater than 15 h a day) on a daily basis for chronic hypoxemia
Patients who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1
Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular co-morbid conditions
Other protocol-defined inclusion or exclusion criteria may apply
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1.Superiority of QVA149 over NVA237 in terms of rate of COPD exacerbations |
52 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Superiority of QVA149 over NVA237 in terms of time to first COPD exacerbation |
52 weeks |
| Safety and tolerability of QVA149 versus NVA237 assessed by adverse events, electrocardiogram (ECG), laboratory tests, and vital signs |
52 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="2200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
19/08/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/05/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
No publication provided
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Target number of patients is 200.
Planned FPFV in India is 2nd August 2010. |