| CTRI Number |
CTRI/2014/07/004743 [Registered on: 16/07/2014] Trial Registered Retrospectively |
| Last Modified On: |
14/11/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose of inhaled corticosteroids (ICS) as background therapy. |
|
Scientific Title of Study
|
A Double-blind, Placebo-controlled, Study Examining the Effect of Orally Administered QAW039 (450 mg QD) on FEV1 and ACQ in Non-atopic, Asthmatic Patients With a Baseline, Pre-bronchodilator FEV1 of 40-80% Predicted, Inadequately Controlled With Low Dose ICS Therapy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2012-003995-38 |
EudraCT |
| CQAW039A2214 (original protocol,Dated 22-Jan-2013) |
Protocol Number |
| NCT01836471 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Murugananthan K |
| Designation |
Head-Clinical Development |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited, Medical Department, Sandoz
House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai.
Mumbai.
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-24958545 |
| Fax |
022-24954112 |
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Murugananthan K |
| Designation |
Head-Clinical Development |
| Affiliation |
Head Clinical Development in Novartis |
| Address |
Novartis Healthcare Private Limited, Medical Department, Sandoz
House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai.
Mumbai.
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Murugananthan K |
| Designation |
Head-Clinical Development |
| Affiliation |
Head Clinical Development in Novartis |
| Address |
Novartis Healthcare Private Limited, Medical Department, Sandoz
House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai.
Mumbai.
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Pharma AG, Basel, Switzerland |
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Private Limited |
| Address |
Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie
Besant Road, Worli, Mumbai – 400 018. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Germany
Belgium
Colombia
India
Poland
South Africa
United States of America
Czech Republic
Romania
Republic of Korea |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Swarnakar |
Getwell Hospital and Research Institute |
Getwell Hospital and Research Institute,20/1,
Dr.Khare Marg,Dhantoli, Nagpur-12
Nagpur
MAHARASHTRA |
91-9822225130
91-712-2461249
rajeshswarnakar@yahoo.co.in |
| DrP AMahesh |
J.S.S.Medical College |
J.S.S. Medical College, Department of Pulmonology,
Shivarathree Rajendra Circle, Mysore - 570 004, Karnataka, India.
Mysore
KARNATAKA |
91-9483702412
mahesh1971in@yahoo.com |
| Dr E Ravindra Reddy |
Kamineni Hospital Pvt Limited |
Kamineni Hospital Pvt Limited,
L B nagar,
Hyderabad.500068
Hyderabad
ANDHRA PRADESH |
91-9394823703
91-04024022244
cr.kamineni@gmail.com |
| Dr Sukhant Bagadia |
KRIMS hospital |
KRIMS hospital, 275, Central Bazaar Road, Ramdaspeth, Nagpur - 440010, Maharashtra, India
Nagpur
MAHARASHTRA |
0712-2451188
0712-2451188
drbagdia@gmail.com |
| Dr Uma Maheshwari K |
M S Ramaiah Medical College and Hospital |
M S Ramaiah Medical College and Hospital,
MSRIT Post, New BEL Rd,
Bangalore 560 054
Bangalore
KARNATAKA |
9483702412
umamohan99@gmail.com |
| DrDeepak Talwar |
Metro Multi Speciality Hospital |
Department of Respiratory Diseases, Metro Multi Speciality Hospital,
L-94, Sector-11, Noida- 201 301
Gautam Buddha Nagar
UTTAR PRADESH |
9810122486
dtlung@hotmail.com |
| Dr Srikanth Krishnamurthy |
Sri Bala Medical Centre & Hospital |
Sri Bala Medical Centre & Hospital, 901,Trichy Road, Ramanathapuram,Coimbatore-641045
Coimbatore
TAMIL NADU |
91-9894257706
91-4224366618
drsrikanthcbe@gmail.com |
| Dr Anthony Mesquita |
TB & Chest Hospital |
TB & Chest Hospital,
Dept. of Pulmonary Medicine, 2nd Floor,St. Inez,
PO Caranzalem,
Panjim – 403 002
North Goa
GOA |
91-9822183365
0832-2425007
mesquita@bsnl.in |
| DrChikkavenkatappa Nagaraja |
Victoria Hospital |
Pulmonary Medicine Depatment,Victoria Hospital,Fort,K R Road,Banglore,Karnataka-560002
Bangalore
KARNATAKA |
9448557093
080-26700182
nagaraj.bmc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Getwell Institutional Ethics Committee_Dr.Rajesh Swarnakar_Nagpur |
Approved |
| Institutional Ecthics Committe,Goa Medical college_Dr.Anthony Mesquita_Panjim |
Approved |
| Institutional Ethics Committee,Banglore Medical college & research Institute (BMCRI) |
Submittted/Under Review |
| Institutional Human Ethics Committee_Dr Srikanth Krishnamurthy_Coimbtore |
Approved |
| J.S.S. Medical College Institutional Ethics Committee |
Submittted/Under Review |
| Kamineni Institutional Ethics Committee_Dr.Ravindra Reddy_Hyderabad |
Approved |
| KRIMS ETHICS COMMITTEE |
Approved |
| M S Ramaiah Medical College and Hospital |
Submittted/Under Review |
| Metro Ethics Review Board |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inhaled corticosteroid (ICS):Fluticasone |
Patients in the ICS cohort will be given the 250 μg dose strength inhaler and will take fluticasone 250 μg twice daily.
Also 3 capsules of Placebo to QAW039 would be given once daily.[Total Duration of therapy is 12 weeks] |
| Comparator Agent |
Placebo to QAW039 |
Patients in the placebo cohort will take 3 capsules placebo to QAW039 once a day. Fluticasone 100 μg twice daily would be given as background therapy.[Total Duration of therapy is 12 weeks] |
| Intervention |
QAW039 |
Patients in the active cohort will take 3 capsules of 150mg QAW039 once a day. Fluticasone 100 μg twice daily would be given as background therapy.[Total Duration of therapy is 12 weeks] |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
•Written informed consent must be obtained before any assessment is performed
•Patients with a diagnosis of persistent asthma (according to Global Initiative for Asthma 2011) for a period of at least 6 months prior to screening
•Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value of 40% to 80% of individual predicted value at screening and prior to treatment
•An Asthma Control Questionnaire score ≥ 1.5 prior to treatment
•Demonstration of reversible airway obstruction
|
|
| ExclusionCriteria |
| Details |
•Pregnant or nursing (lactating) women
•Acute illness other than asthma at the start of the study
•Patients with clinically significant laboratory abnormalities at screening
•Patients with clinically significant condition which may compromise subject safety or interfere with study evaluation
•Use of other investigational drugs at the time of enrollment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in trough FEV1 from baseline to 12 weeks of post-baseline treatment in non-atopic asthmatic patients.
To assess the efficacy of QAW039 by Lung Function Assessed by trough Forced Expiratory Volume for 1 Second (FEV1) in non-atopic asthmatics |
Baseline and Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the change in asthma control as measured by the asthma control questionnaire (ACQ) from baseline to week 12. |
Baseline to Week 12 |
|
|
Target Sample Size
|
Total Sample Size="336"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
30/08/2014 |
| Date of Study Completion (India) |
05/01/2016 |
| Date of First Enrollment (Global) |
28/05/2013 |
| Date of Study Completion (Global) |
04/02/2016 |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Clinical Study Report (CSR)is planned to be generated tenetatively by Apr-2015. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, double-blind, placebo-controlled study to determine whether, in patients with persistent, moderate-to-severe, non-atopic (skin prick test- and specific IgE-negative) asthma inadequately controlled by inhaled corticosteroid (ICS) therapy (100 μg fluticasone BID), 12-weeks treatment with QAW039 at a dose of 450 mg QD (compared to placebo) improves FEV1 and symptom control as measured by the ACQ. |