| CTRI Number |
CTRI/2009/091/000082 [Registered on: 06/04/2009] |
| Last Modified On: |
23/09/2014 |
| 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
|
Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD) (INSIST)
|
|
Scientific Title of Study
|
A 12 Week Treatment, Multi-Center, Randomized, Parallel Group, Double Blind, Double Dummy Study to Assess the Superiority of Indacaterol (150 µg o.d.) Via a SDDPI in Patients With Moderate to Severe COPD, Using Salmeterol (50 µg b.i.d.) as an Active Comparator Delivered Via a DISKUS Inhaler |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CQAB149B2349 |
Protocol Number |
| NCT00821093 |
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, Sandoz House
Shivsagar Estate, Dr. Annie Besant Road, Worli
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022 24958533 |
| Fax |
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, Sandoz House
Shivsagar Estate, Dr. Annie Besant Road, Worli
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022 24958533 |
| Fax |
24954112 |
| Email |
kamala.rai@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Pharma AG CHBS, WSJ-158.3.37.3, Novartis Pharma AG CH - 4056, Basel, Switzerland |
|
Primary Sponsor
Modification(s)
|
| Name |
Novartis Healthcare Pvt Ltd |
| Address |
5th floor
Shivsagar Estate
Dr. Annie Besant Road
Worli, Mumbai 400 018
INDIA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Manish Jain |
Asthama Bhawan |
Sawai Maan Singh Medical College, R-3,Sec-6,Near Cinestar, Vidhyanagar-302023
Jaipur
RAJASTHAN |
0141-2281010
drvirendrasingh@yahoo.com |
| K Jagannath |
Chennai Thoracic Research Institute |
Director- Chennai Thoracic Research Institute,53, Sterling Road, Nungambakkam- 600034
Chennai
TAMIL NADU |
044 - 28279111
044-28250957
jagannath@sify.com |
| Dr. S Balamurugan |
Chest Clinic |
# 2, Janaki Nagar Extension,Valasaravakkam-600 087
Chennai
TAMIL NADU |
044-24862202
dr.s.bala@gmail.com |
| Dr. D. J. Christopher |
Christian Medical College |
Professor and Head, Department of Pulmonary Medicine,Christian Medical College-632004
Vellore
TAMIL NADU |
0416-2283373
resmed@cmcvellore.ac.in |
| Dr. Mathew Thomas |
Health & Research Centre |
TC-1/ 907, 1st floor,Devi scan building, Kumarapuram, Medical College P.O.-695011
|
+91 9447058561
healthtrials@gmail.com |
| R C Sahoo |
Kasturba Medical College |
Dept. of Chest Medicine,N.G. Road, Attavar-575001
Bangalore
KARNATAKA |
0824-2445858
0824-2425092
meera.lobo@acunovalife.com |
| Dr. Suhas Kalashetti |
KEM Hospital |
Administrative Block, KEM Hospita,Banoo Coyaji Bldg., Sardar Moodliar Road, Rasta Peth-411 011
Pune
MAHARASHTRA |
skalashetti@yahoo.com |
| Dr. Srinivas Rao |
Osmania Hospital |
Professor of Medicine, Department of General Medicine,,Osmania Medical College, Afzalgunj-500012
Hyderabad
ANDHRA PRADESH |
040-24744424
drnanyam@yahoo.com |
| Dr. Anthony Mesquita |
TB and Chest Hospital |
TB & Chest Disease, ,St. Inez, -403002
|
0832-2225088
0832 2425007
drlalita@sancharnet.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, KMC |
Approved |
| Chennai Thoracic Research Institute Ethics Committtee |
Approved |
| Ethics Committee |
Approved |
| Ethics Committee, K.E.M Hospital Research Centre |
Approved |
| Ethics committee, Osmania Hospital |
Approved |
| Goa Medical College and Hospitals Local Ethics Committee |
Approved |
| Independent Human Ethics Committee |
Approved |
| Institutional Ethics Committee, Kasturba Medical College |
Approved |
| Swasthya Kalyan Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Chronic Obstructive Pulmonary Disease (COPD), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indacaterol |
150 µg
|
| Comparator Agent |
Salmeterol |
50 µg |
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Adults aged ≥40 years
2) Diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2007) and:
Smoking history of at least 10 pack years
Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value at screening (Visit 2).
Post-bronchodilator FEV1/FVC < 70% at screening
|
|
| ExclusionCriteria |
| Details |
1) Patients who have received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
2) Patients requiring long-term oxygen therapy (>15 h a day) for chronic hypoxemia
3) Patients who have had a respiratory tract infection within 6 weeks prior to screening
4) Patients with concomitant pulmonary disease
5) Patients with a history of asthma
6) Patients with diabetes Type I or uncontrolled diabetes Type II
7) Any patient with lung cancer or a history of lung cancer
8) Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time
9) Patients with a history of long QT syndrome or whose QTc interval (Fridericia's) measured at screening is prolonged
10) Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period
11) Patients unable to successfully use a dry powder inhaler device, or perform spirometry measurements
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 12 hr Area Under the Curve (AUC) forced expiratory volume in 1 second (FEV1) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] |
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to 24 hr post-dose of (trough) forced expiratory volume in 1 second (FEV1) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] |
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="1084"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/01/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
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)
|
Number of patients to be recruited from India is 140. |