| CTRI Number |
CTRI/2009/091/000910 [Registered on: 23/12/2009] |
| Last Modified On: |
02/10/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo |
|
Scientific Title of Study
|
A 26-week Treatment, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CNVA237A2304 |
Protocol Number |
| NCT01005901 |
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
Modification(s)
|
| Name |
Muruganananthan K |
| Designation |
Head Clinical Department |
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited, Medical Department, Sandoz House,
Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
02224958545 |
| Fax |
02224954112 |
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Muruganananthan K |
| Designation |
Head Clinical Department |
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited, Medical Department, Sandoz House,
Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
02224958545 |
| Fax |
02224954112 |
| 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 Road, Worli, Mumbai 400018 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. K. Jagannath |
Chennai Thoracic Research Institute |
47, Sterling road,,Nungambakkam-600034
Chennai
TAMIL NADU |
9144-28250957
+91-44-28250957
jagannath@sify.com |
| Dr. S. Balamurugan |
Chest Research Centre |
# 2, Janaki Nagar Extension,,Valasaravakkam, -600 087
Chennai
TAMIL NADU |
91-44-24862202
91-44-24862202
dr.s.bala@gmail.com |
| Dr. Rajendra Mehta |
Dr. Mehta's Allergy & Asthma Care and Research Centre |
107, Asawa Chambers,,Asawa Chambers,-452001
Indore
MADHYA PRADESH |
00-91-731-2468737
+91 0731 2468737
drrajendramehta@hotmail.com |
| Dr. Pattabhi Raman |
Kovai Medical Centre & Hospital |
Respiratory Dept, P.O.Box 3209,,Avanashi road, - 641014
Coimbatore
TAMIL NADU |
91-422-2627782
+91 422 2625080
vr.pattabhiraman@gmail.com |
| Dr. Ravindra Sarnaik |
Leela More's Chest Clinic & Critical Care Unit |
57, North Avenue,,Dhantoli, -440012
Nagpur
MAHARASHTRA |
91-712-2436384
dr.rsarnaik@yahoo.com |
| Dr. Deepak Talwar |
Metro Multispecialty Hospital |
L-94, Sector 11,-201301
|
00-91-0120- 2533491
+91-120-2533347
dtlung@hotmail.com |
| Dr. N. Srinivas Rao |
Osmania General Medical Hospital |
Department of General Medicine,Afzalgunj-500012
Hyderabad
ANDHRA PRADESH |
91-40-24744424
91-40-24744424
drnanyam@yahoo.com |
| Dr. K. Srikanth |
PSG Hospital |
Professor & Head of TB & Respiratory Diseases,,Avinashi Road, Peelamedu,-641004
Coimbatore
TAMIL NADU |
91-40-2575262
+91 422 2573556
drsrikanthcbe@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Apex Independent ethics Committee |
Approved |
| Breathe Trust Ethics Committee, Leela Mores Chest Clinic and Critical Care Unit |
Approved |
| Ethics Committee Metro Hospital and Heart Institute |
Approved |
| Ethics committee of PSG hospital |
Approved |
| Ethics Committee, Chennai Thoracic Research Institute |
Approved |
| Ethics Committee,Osmania General Hospital, |
Approved |
| Independent Ethics Committee, Chest Research Centre |
Approved |
| KMCH Ethics Committee |
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
|
| Type |
Name |
Details |
| Intervention |
NVA237A |
Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI) |
| Comparator Agent |
Placebo Comparator |
Placebo delivered once daily via SDDPI |
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
0.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to
initiation of any study-related procedure.
2. Patients with moderate to severe stable COPD (Stage II or Stage III) according to the (GOLD
Guidelines 2008).
3. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years
are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
4. Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and postbronchodilator
FEV1/FVC < 0.7 at Visit 2 (day -14)
5. Patients, according to daily electronic diary data between Visit 2 (-14) and Visit 3 (day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3. |
|
| ExclusionCriteria |
| Details |
1.Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
2.Patients with concomitant pulmonary disease
3.Patients with a history of asthma
4.Any patient with lung cancer or a history of lung cancer
5.Patients with a history of certain cardiovascular comorbid conditions
6.Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
7.Patients in the active phase of a supervised pulmonary rehabilitation program
8.Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents 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 |
| Trough Forced Expiratory Volume in 1 Second (FEV1) |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| * George's Respiratory Questionnaire (SGRQ) |
26 weeks |
| * Transition Dyspnea Index (TDI) |
26 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="800"
Sample Size from India="147"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
18/02/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
29/10/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
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
|
Target number of patients from India is 180.
Planned FPFV for India is 30th Jan 2010. |