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CTRI Number  CTRI/2010/091/000285 [Registered on: 26/07/2010]
Last Modified On: 23/09/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD) 
Scientific Title of Study   A randomized, double-blind, placebo-controlled, 2-period, cross-over study to assess the efficacy and safety of differing doses of NVA237 administered either once daily or twice daily, in patients with moderate to severe chronic obstructive pulmonary disease (COPD) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CNVA237A2208  Protocol Number 
NCT01119950  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 

Not Applicable
N/A

India 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr. Kamala Rai 
Designation   
Affiliation   
Address  Novartis Healthcare Private Limited, Medical Department,
Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India 
Phone  022 -24958533  
Fax  022 -24954112  
Email  kamala.rai@novartis.com  
 
Details of Contact Person
Public Query  
Name  Dr. Kamala Rai 
Designation   
Affiliation   
Address  Novartis Healthcare Private Limited, Medical Department,
Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India 
Phone  022 -24958533  
Fax  022 -24954112  
Email  kamala.rai@novartis.com  
 
Source of Monetary or Material Support  
Novartis Pharma AG, BAsel, Switzerland 
 
Primary Sponsor
Modification(s)  
Name  Novartis Healthcare Private Limited 
Address  Sandoz House, 5th floor Shivsagar Estate Dr. Annie Besant Road Worli, Mumbai 400 018 INDIA  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Pramod Niphadkar  Asthma Allergy center  Gurukripa, 1st Flr, 66,,Hindu Colony Lane 1,-400014
Mumbai
MAHARASHTRA 		 022-24105656
022-24183232
dr_niphadkar@vsnl.net  
Dr. Rajesh Swarnakar  Get Well Hospital & Research Institute  plot no. 20/1, Dr. Khare Marg,Dhantoli,-440012
Nagpur
MAHARASHTRA 		 +91-9822225130
+91-712-2461249
rajeshswarnakar@yahoo.co.in 
Dr. Sayed Jafrey  Indore Chest Center  Morya Arcade 1/2 Old Plasia,-452018
Indore
MADHYA PRADESH 		 +91-7314064786
+91-7314064786
drszjafrey@gmail.com 
Dr. Ravindra Sarnaik  Leela More's Chest Clinic & Critical Care Unit  57, North Avenue,,Dhantoli,-440 012
Nagpur
MAHARASHTRA 		 00-91-712-2436384
00-91-712-2420373
dr.rsarnaik@yahoo.com 
Dr. Deepak Talwar  Metro Center for Respiratory Disease  L 94, Sector 11, ,Noida -201301
New Delhi
DELHI 		 00-91-0120- 2533491
00-91-0120-2533347
dtlung@hotmail.com 
Dr. Srikanth Krishnamurthy  PSG Hospital  TB & Respiratory Diseases,Avinashi Road, Peelamedu, -641004
Coimbatore
TAMIL NADU 		 0422-2570170
0422-4398412
drsrikanthcbe@gmail.com  
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Apex Independent Ethics Committee  Approved 
Ethics Committee (Breathe Trust)  Approved 
Ethics Committee for Asthma, Allergy and COPD (ECAAC)  Not Applicable 
Independent Ethics Committee  Approved 
Institutional Human Ethics Committee  Approved 
Metro Ethics Review Board  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Chronic Obstructive Pulmonary Disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo   Placebo: Experimental  
Intervention  NVA237  NVA237 group 1: Experimental-12.5 microgram q.d. 
Intervention  NVA237   NVA237 group 2: Experimental-12.5 microgram b.i.d  
Intervention  NVA237  NVA237 group 3: Experimental-25 microgram q.d. 
Intervention  NVA237  NVA237 group 4: Experimental-25 microgram b.i.d  
Intervention  NVA237   NVA237 group 5: Experimental- 50 microgram q.d. 
Intervention  NVA237   NVA237 group 6: Experimental-50 microgram b.i.d  
Intervention  NVA237   NVA237 group 7: Experimental-100 microgram q.d. 
 
Inclusion Criteria
Modification(s)  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male and Female patients age 40 years or more
Diagnosis of COPD (moderate-to-severe 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 <80% and ≥30% of the predicted normal value
Post-bronchodilator FEV1/FVC (forced vital capacity) <0.7
 
 
ExclusionCriteria 
Details  *Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for in the 6 weeks prior to the first visit * Patients who have had a respiratory tract infection within 4 weeks prior to the first visit * Patients with concomitant pulmonary disease or a history of asthma * Patients with diabetes Type I or uncontrolled diabetes Type II * Any patient with lung cancer or a history of lung cancer * Patients with a history of certain cardiovascular comorbid conditions * Patients with eczema, known high IgE levels or a known positive skin prick test * Patients participating in the active phase of a pulmonary rehabilitation programme * Other protocol-defined inclusion/exclusion criteria may apply  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the relationship of NVA237 on trough forced expiratory volume in one second (FEV1)   Time Frame: 28 days  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the relationship of NVA237 on FEV1 AUC0-24 hours   Time Frame: 28 days  
To evaluate the safety and tolerability of NVA237 over the course of treatment   Time Frame: 28 days  
 
Target Sample Size
Modification(s)  		 Total Sample Size="360"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  15/04/2010 
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    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Target number of patients from India is 72. Planned FPFV in India is 30 July 2010. 
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