A 12 Week study to assess Safety & efficacy of QAW039 when added to standard of care in patients with uncontrolled asthma

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/06/014543
• Date of registration: 15-06-2018
• Prospective Registration: No
• Primary sponsor: Novartis Healthcare Pvt Ltd
• Public title: A 12 Week study to assess Safety & efficacy of QAW039 when added to standard of care in patients with uncontrolled asthma
• Scientific title: A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma - ZEAL
• Date of first enrolment: 04-06-2018
• Target sample size: 650
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=23591
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 3

Countries of recruitment

Argentina, Canada, Czech Republic, Greece, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Russian Federation, Serbia , Slovakia, South Africa, Spain, Taiwan, United States of America

Contacts

• Name: Murugananthan K
• Affiliation: Novartis Healthcare Private Limited

• Name: Murugananthan K
• Affiliation: Novartis Healthcare Private Limited

Key inclusion & exclusion criteria

Inclusion criteria: 1 Written informed consent and assent (if applicable) must be obtained within 14 days prior

to or at Visit 1 before any assessment is performed including any adjustment to asthma

medication.

2 Male and female patients at a minimum age of 12 years (or higher minimum age limit as

allowed by health authority and/or independent ethics committee/institutional review

board (IEC/IRB) approvals

3Patients must have a diagnosis of asthma (according to GINA 2016) for a period of at least

6 months prior to Visit 1

4 Patients who have been treated with:

ï?· Medium dose ICS, or

ï?· High dose ICS, or

ï?· Low dose ICS plus long-acting beta agonist (LABA), or

ï?· Low dose ICS plus leukotriene receptor antagonist (LTRA), or

ï?· Medium dose ICS plus LABA

for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks

prior to Visit 1

5 for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks

prior to Visit 1

6 Patients must have a daytime asthma symptom score (0 to 6 scale) of >=1 per day during 4

of the last 7 days of the placebo run-in period

7 Patients must have a total daily SABA use >=1 puff per day during 4 of the last 7 days of

the placebo run-in period

8 Demonstrated reversible airway obstruction as determined by the central reader from the

spirometry vendor at Visit 1 or Visit 101. Reversibility is defined as an increase of >=12%

and >=200 ml in FEV1 approximately 10 to 15 minutes after administration of 400 mcg of

salbutamol/albuterol (or equivalent). Spacer devices are permitted for administration of

salbutamol/albuterol (or equivalent) during reversibility testing only. The Investigator or

delegate may decide whether or not to use a spacer for the reversibility testing

If reversibility is not demonstrated at Visit 1, reversibility will be attempted at Visit

101. If not achieved at Visit 101, then one additional attempt to demonstrate

reversibility is permitted within 4 days following Visit 101 in an ad -hoc visit to meet

this eligibility criterion

If reversibility is not demonstrated at Visit 1, reversibility will be attempted at Visit

101. If not achieved at Visit 101, then one additional attempt to demonstrate

reversibility is permitted within 4 days following Visit 101 in an ad -hoc visit to meet

this eligibility criterion

9 An ACQ score >= 1.5 at Visit 199
Exclusion criteria: Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days,

whichever is longer.

2. History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar

3. History of lactose or milk sensitivity.

4. Patients with a history or current diagnosis of ECG abnormalities indicating significant

risk of safety for patients participating in the study such as:

ï?· Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular

tachycardia, and clinically significant second or third degree atrioventricular (AV)

block without a pacemaker.

ï?· History of familial long QT syndrome or known family history of Torsades de Pointes.

5. Patients with a resting QTcF (Fridericia) >=450 msec (male) or >=460 msec (female) at Visit

6. Use of agents known to prolong the QT interval unless it can be permanently discontinued

for the duration of the study.

7. Patients with a history of malignancy of any organ system (other than localized basal cell

carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5

years, regardless of whether there is evidence of local recurrence or metastases.

8. 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 human

chorionic gonadotropin (hCG) laboratory test.

9. Women of child-bearing potential, defined as all women physiologically capable of

becoming pregnant, unless they are using basic methods of contraception during dosing of

study drug. Basic contraception methods include:

ï?· Total abstinence (when this is in line with the preferred and usual lifestyle of the

subject) if allowed as an effective method of contraception by local regulations.

Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods)

and withdrawal are not acceptable methods of contraception

ï?· Female sterilization (have had surgical bilateral oophorectomy with or without

hysterectomy) or tubal ligation at least six weeks before taking study treatment. In

case of oophorectomy alone, only when the reproductive status of the woman has

been confirmed by follow up hormone level assessment

ï?· Male sterilization (at least 6 months prior to screening). For female patients on the

study, the vasectomized male partner must be the sole partner for that subject

chemical classes to QAW039.





Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Asthma Health Condition 2: J454- Moderate persistent asthma

Intervention(s)

Intervention1: QAW039 150mg tablet: QAW039 Once daily
Route of administration -Oral for 24 weeks
Control Intervention1: Matching placebo to QAW039A 150 mg tablet: Once daily
Route of administration-Oral for 24 weeks

Primary Outcome(s)

1Pre-dose Forced Expiratory Volume in 1 second (FEV1)Timepoint: 1Pre-dose Forced Expiratory Volume in 1 second (FEV1)

Secondary Outcome(s)

Daytime asthma symptom scoreTimepoint: 12 weeks

Short-acting beta agonist (SABA) taken per day

Timepoint: 12 weeks

Secondary ID(s)

CQAW039A2317, Version 00 dated 10/May/2017

NCT03226392

Source(s) of Monetary Support

Novartis Pharma AG, Basel, Switzerland

Ethics review

Status: Approved
Approval date: 09/04/2018
Contact:

Ethics Committee of Care Institute of Medical Sciences

Status: Approved
Approval date: 26/04/2018
Contact:

Institutional Ethics Committee - Sri Bala Medical Centre & Hospital

Status: Approved
Approval date: 07/05/2018
Contact:

Rhythm Heart Institute Ethics Committee

Status: Approved
Approval date: 08/06/2018
Contact:

Institutional Ethics Committee, Shri Mahant Indiresh Hospital

Status: Approved
Approval date: 22/08/2018
Contact:

Institutional Ethics Committee, Midland Healthcare and Research Centre

Status: Approved
Approval date: 03/10/2018
Contact:

Siddhi Hospital Institutional Ethics Committee, Siddhi Hospital

Status: Approved
Approval date: 27/10/2018
Contact:

Ethics Committee, S. P. Medical & A.G.Hospital, Dr Surendra Kumar

Status: Approved
Approval date: 14/02/2019
Contact:

Yenepoya University Ethics Committee, Yenepoya Medical College Hospital