| CTRI Number |
CTRI/2009/091/000066 [Registered on: 09/03/2009] |
| Last Modified On: |
07/05/2024 |
| 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
|
Efficacy and Safety of Indacaterol in Adults (40 Years and Above) With Chronic Obstructive Pulmonary Disease (COPD) |
|
Scientific Title of Study
|
A Phase III, 26-Week Multi-Center Randomized Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety and Tolerability of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease (COPD) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CQAB149B2333 |
Protocol Number |
| NCT00792805 |
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 Pvt Ltd., Pharmaceuticals Division, Sandoz House
Shivsagar Estate, Dr. Annie Besant Road, Worli
Mumbai
MAHARASHTRA
400018
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 Pvt Ltd., Pharmaceuticals Division, Sandoz House
Shivsagar Estate, Dr. Annie Besant Road, Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-24958533 |
| Fax |
022-24954112 |
| 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 Phone: +41 |
|
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
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rajendran K |
HEALTH AND RESEARCH CENTRE |
T.C. 1/907, Ist floor- Devi Scans Building. ,Kumarapuram,Medical College P.O.-695 011
|
0471-2554911
healthtrials@gmail.com |
| Dr Nirmal Choraria |
Nirmal Hospital Pvt. Ltd. |
Ring Road, Surat, Gujarat 395002, India
Surat
GUJARAT |
9825142549
nirmal_choraria@yahoo.com |
| Dr. Nagraj C |
SDS Tuberculosis and Rajiv Gandhi Institute of Chest Disease |
Hosur Road,Dharmaram College Post- 560029
Bangalore
KARNATAKA |
080 26632634, 08026640599
080 25501144
rgicdtrials@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethical Committee Bangalore Medical College Research Institute |
Approved |
| Independent Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Obstructive Pulmonary Disease (COPD), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indacaterol |
150 µg once daily (od) via SDDPI |
| Comparator Agent |
Placebo Comparator |
Placebo od via SDDPI |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Inclusion Criteria:
Adults aged ≥ 40 years
Diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
1. Smoking history of at least 10 pack years
2. Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
3. Post-bronchodilator FEV1/FVC < 70%
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
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 (Bazett'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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Forced expiratory volume in 1 second (FEV1) at approximately 23.5 hours after inhalation of indacaterol [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
|
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Long term safety, including adverse events [ Time Frame: During 26 weeks of treatment ] [ Designated as safety issue: Yes ]
|
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="558"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "492"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
24/12/2009 |
| Date of First Enrollment (Global) |
12/01/2009 |
| Date of Study Completion (Global) |
26/02/2010 |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="3"
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
|
The number of patients proposed to be recruited from India is 30. |