CTRI

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CTRI Number

CTRI/2009/091/000260 [Registered on: 09/06/2009]

Last Modified On:

03/10/2014

Post Graduate Thesis

Type of Trial

Interventional

Type of Study
Modification(s)

Drug

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study
Modification(s)

Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

Scientific Title of Study

A 26-Week Treatment, Multi-Center, Randomized, Double-Blind, Double- Dummy, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control

Trial Acronym

Secondary IDs if Any
Modification(s)

Secondary ID	Identifier
CQAB149B2336	Protocol Number
NCT00567996	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 Development
Affiliation
Address	Novartis Healthcare Pvt. Ltd., 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 Development
Affiliation
Address	Novartis Healthcare Pvt. Ltd., Medical Department, Sandoz House Shiv Sagar estate, Dr. Annie Besant Road, Worli Mumbai MAHARASHTRA 400 018 India
Phone	02224958533
Fax	02224954112
Email	murugananthan.k@novartis.com

Source of Monetary or Material Support

Novartis Pharma AG, Basel, Switzerland

Primary Sponsor
Modification(s)

Name	Novartis Health care Private Limited
Address	Novartis India Limited 5th Floor, Sandoz House, Dr Annie Beseant Road, Worli,Mumbai 400018
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
Nil

Countries of Recruitment
Modification(s)

Brazil
Canada
Colombia
Czech Republic
Denmark
Finland
France
Germany
Hungary
India
Italy
Norway
Peru
Russian Federation
Slovakia
Taiwan

Sites of Study

No of Sites = 11
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr. Pradyut Waghray	Apollo Hospital	Consultant Pulmonologist, Apollo Hospitals,Jubilee Hills- 500033 Hyderabad ANDHRA PRADESH	09246531036 040-23543270 pradyut_waghray@rediffmail.com
Dr. Manish Jain	Asthama Bhawan Sawai Maan Singh Medical College	College R-3, Sec-6, Near cinestar, Vidhyanagar-302023 Jaipur RAJASTHAN	91-9414051212 drmanish_2003@yahoo.co.in
Dr. Pramod Niphadkar	Asthma Allergy Centre	Gurukripa, 1st Flr, 66,Hindu Colony Lane 1, Dadar (E)-400014 Mumbai MAHARASHTRA	09892438695 022-24183232 dr_niphadkar@vsnl.net
Dr. Jagannath	Chennai Thoracic Research Institute	53, Sterling Road,Nungambakkam-600034 Chennai TAMIL NADU	09840031548 044-28250957 jagannath@sify.com
Dr. Christopher	Christian Medical College	Prof and Head, Department of Pulmonary Medicine,Christian Medical College-632004 Vellore TAMIL NADU	09443306573 resmed@cmcvellore.ac.in
Dr. Mathew Thomas	Kerala Institute Of Medical Sciences	Dept Of Internal Medicine,P.B. No.1, Anayara. P.O.-695029	91-471-2447575 91-471-2446460 healthtrials@gmail.com
Dr. R C Sahoo	KMC Hospital	Dept. of Chest Medicine,N.g. Road, Attavar-575001 Bangalore KARNATAKA	09844145770 0824-2425092 meera.lobo@acunovalife.com
Dr. Srinivas Rao	Osmania Hospital	Professor of Medicine, Department of General Medicine,Osmania Medical College, Afzalgunj-500012 Hyderabad ANDHRA PRADESH	09440235092 040-24744424 drnanyam@yahoo.com
Dr. K Srikanth	PSG Hospital	Professor & Head of TB & Respiratory Diseases,,PSG Hospital, Avinashi Road, Peelamedu,-641004 Coimbatore TAMIL NADU	9894257706 040-23543270 drsrikanthcbe@gmail.com
Dr. T Mohan Kumar	Sri Ramkrishna Hospital	Institute of Pulmonary Medicine,Sri Ramkrishna Hospital-641044 Coimbatore TAMIL NADU	9894622018 0422-2210521 ipmr_asthma@hotmail.com.com
Dr. Anthony Mesquita	TB & Chest Hospital	Dept TB & Chest disease , TB & Chest Hospital,,St.Inez. Caranazalem-403002	91-832-2225088 91-832-2425007 drlalita@sancharnet.in

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 11
Name of Committee	Approval Status
Apollo Hospitals Ethics Committee	Approved
Asthma Allergy Centre Ethics Committee	Approved
Ethics Committee, Chennai Thoracic Research Institute	Approved
Ethics Committee, Osmania Medical College	Approved
Institutional Ethics Committee, Kasturba Medical College	Approved
Institutional Human Ethical Committee	Approved
Institutional Human Ethics Committee, PSG	Approved
Institutional Review Board (Research & Ethics Committees), CMC	Approved
Local Ethics Committee, Goa Medical College	Approved
Sri Ramakrishna Hospital Ethics Committee	Approved
Swasthya Kalyan Ethics Committee	Approved

Regulatory Clearance Status from DCGI
Modification(s)

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	Chronic Obstructive Pulmonary Disease (COPD),

Intervention / Comparator Agent

Type	Name	Details
Intervention	Indacaterol	Indacaterol 150 Mcg, delivered via SDDPI
Comparator Agent	Placebo	Placebo to indacaterol (150 Mcg) delivered via SDDPI
Comparator Agent	Placebo	Placebo to salmeterol (50 Mcg) delivered via the salmeterol proprietary dry powder inhalation device
Comparator Agent	Salmeterol	Salmeterol (50 Mcg) delivered via the salmeterol proprietary dry powder inhalation device

Inclusion Criteria
Modification(s)

Age From	40.00 Day(s)
Age To	0.00 Day(s)
Gender	Both
Details	1.Male and female adults aged greater than or equal to 40 years, who have signed an Informed Consent Form prior to initiation of any study related procedure 2. Co operative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2006) and including: a) Smoking history of at least 20 pack years b) Post-bronchodilator FEV1 less than 80 percent and greater than or equal to 30 percent of the predicted normal value c) Post-bronchodilator FEV1 FVC less than 70 percent

ExclusionCriteria

Details

1.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum fhuman chorionic gonadotrophin laboratory test (greater than 5 mIU per mL)
2. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, including women whose career, lifestyle, or sexual orientation
precludes intercourse with a male partner and women whose partners have been sterilized
by vasectomy or other means, UNLESS they meet the following definition of postmenopausal.
12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous
amenorrhea with serum FSH levels greater than40 mIU per mL or are using one or more of the
following acceptable methods of contraception.
a) surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)
b) hormonal contraception (implantable, patch, oral)
c) double-barrier methods (any double combination of. IUD, male or female condom
with spermicidal gel, diaphragm, sponge, cervical cap)
Acceptable methods of contraception may include total abstinence at the discretion of
the investigator in cases where the age, career, lifestyle, or sexual orientation of the
patient ensures compliance. Periodic abstinence (e.g., calendar, ovulation,
symptothermal, post-ovulation methods) and withdrawal are not acceptable methods
of contraception. Reliable contraception should be maintained throughout the study
and for 30 days after study drug discontinuation
3. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit
1 or during the run-in period
4. Patients requiring oxygen therapy for chronic hypoxemia (excluding acute COPD
exacerbation). This is typically patients requiring oxygen therapy greater than15 h per day delivered
by home oxygen cylinder or concentrator.
5. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients
who develop a respiratory tract infection between Visit 1 and Visit 3 must discontinue
from the trial, but may be permitted to re-enroll at a later date (at least 6 weeks after the
start of the respiratory tract infection)
6. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed
by chest x-ray to be no longer active) or clinically significant bronchiectasis
7. Patients with a history (up to and including Visit 1) of asthma indicated by (but not limited
to).
a) blood eosinophil count greater than 400 per mm3
b) onset of respiratory symptoms prior to age 40 years
8. Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a
history of blood glucose levels consistently outside the normal range or HbA1C greater than 8.0 %
of total Hb measured at Visit 1
9. Patients who, in the judgment of the investigator or the responsible Novartis personnel,
have a clinically relevant laboratory abnormality or a clinically significant condition such
as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable AF),
uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia,
hyperadrenergic state or any condition which in the investigatorâ€™s opinion might
compromise patient safety or compliance, interfere with evaluation, or preclude
completion of the study
10. Any patient with lung cancer or a history of lung cancer
11. Any patient with active cancer or a history of cancer with less than 5 years disease free
survival time (whether or not there is evidence of local recurrence or metastases).
Localized basal cell carcinoma (without metastases) of the skin is acceptable. Patients
with a history of cancer (excluding lung cancer) and 5 years or more disease free survival
time may only be included in the study by agreement with Novartis Headquarters
personnel on a case-by-case basis
12. Patients with a history (or family history) of long QT syndrome or whose QTc interval
(Bazettâ€™s) measured at Visit 1 or Visit 3 is prolonged. greater than 450 ms (males) or greater than 470 ms
(females) as assessed by the central ECG interpretation (Visit 1) or investigatorâ€™s
interpretation of the pre-dose ECGs (Visit 3). Patients who fail the screening ECG (with
the exception of machine failures) should not be re-screened.
13. Patients with a history of hypersensitivity to any of the study drugs or to drugs with
similar chemical structures including untoward reactions to sympathomimetic amines or
inhaled medication or any component thereof
14. Patients who do not maintain regular dayornight, wakingorsleeping cycles (e.g., night shift
workers)
15. Patients who have had treatment with investigational drugs at the time of enrollment, or
within 30 days or 5 half-lives prior to Visit 1, whichever is longer.
16. Patients who have had live attenuated vaccinations within 30 days prior to Visit 1 or
during the run-in period. Inactivated Influenza vaccination, pneumococcal vaccination or
any other inactivated vaccine is acceptable provided it is not administered within 48 h
prior to Visits 1, 2 or 3.
17. Treatments for COPD and allied conditions. the following medications must not be used
prior to Visit 1 for at least the minimum washout period specified below or at any time
during the study.
a) The long acting anti-cholinergic agent tiotropium. 7 days
b) Short acting anti-cholinergics. 8 h
c) Fixed combinations of Î²2-agonists and inhaled corticosteroids. 48 h
(Patients taking fixed dose combination therapy must be switched to an equivalent
inhaled corticosteroid monotherapy plus salbutamol or albuterol as rescue therapy)
d) Fixed combinations of short acting Î²2-agonists and short acting anticholinergics (e.g.
Combivent). 8 h
e) LABAs. 48 h
f) SABAs (other than those prescribed in the study). 6 h
g) Theophylline and other xanthines. 1 week
h) Parenteral or oral corticosteroids. 1 month
18. Treatments for COPD and allied conditions. The following medications should not be
used unless they have been stabilized.
a) Cromoglycate, nedocromil, ketotifen, inhaled or nasal corticosteroids and leukotriene
antagonists - at least one month prior to Visit 1
b) Antihistamines (excluding those in 20c below) - at least 5 days prior to Visit 1
19. Other excluded medications.
a) Non-potassium sparing diuretics (unless administered as a fixed dose combination
with a potassium conserving drug)
b) Beta-blocking agents
c) Cardiac anti-arrhythmics Class Ia (e.g., disopyramide, procainamide, quinidine),
Class III (e.g., amiodarone, dofetilide, ibutilide, sotalol), terfenadine, astemizole,
mizolastin and any other drug with potential to significantly prolong the QT interval.
d) Tricyclic antidepressants and monoamino-oxidase inhibitors. [Fluoxetine or any
other selective serotonin uptake receptor inhibitor may only be permitted if the
patientâ€™s treatment regimen has been stable for at least 1 month prior to Visit 1, their
Visit 1 ECG is normal and they have no clinical evidence of prior ECG
abnormalities]
20. Patients unable to successfully use a dry powder inhaler device or perform spirometry
measurements
21. Patients with a known history of non-compliance to medication or who are unable or
unwilling to complete a Patient Diary

Method of Generating Random Sequence

Stratified randomization

Method of Concealment

Centralized

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Forced expiratory volume in 1 second (FEV₁) after 12 weeks of treatment measured 24 hours after having taken medication	After 12 weeks of treatment

Secondary Outcome

Outcome	TimePoints
Total score of St.George's Respiratory Questionnaire	26 weeks
Health related quality of life assessments	26 weeks
Effect of indacaterol on percentage of "days of poor control" of COPD over 26 weeks	26 weeks
Time to first COPD exacerbation and COPD exacerbation rate	26 weeks
Lung function tests (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC])	26 weeks
Trough FEV1	26 weeks
Standardized area under the curve (AUC) for FEV1	26 weeks

Target Sample Size
Modification(s)

Total Sample Size="972"
Sample Size from India="131"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial

Phase 3

Date of First Enrollment (India)
Modification(s)

11/01/2008

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

27/11/2007

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial
Modification(s)

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
Modification(s)

26-week treatment, multi center, randomized, double blind, double dummy, placebo

controlled, parallel group study to assess the efficacy and safety of indacaterol (150 Î¼g o.d.) in

patients with chronic obstructive pulmonary disease, using salmeterol (50 Î¼g b.i.d.) as an active

control. The study population will consist of approximately 972 adult males and females from 16 different countries and age 40 years and over with a clinical diagnosis of moderate to severe COPD and a smoking history of at least 20 pack years. Patients will randomized into the study with the intention that at least 777 patients complete the study. Primary objective is to assess indacaterol (150 Î¼g) superiority in patients with COPD as compared to placebo with respect to 24 h post dose trough FEV1 after 12 weeks of treatment. Number of patients from India is 131.