A 12 Week study to assess Safety & efficacy of QAW039 when added to standard of care in patients with uncontrolled asthma
- Conditions
- Health Condition 1: null- AsthmaHealth Condition 2: J454- Moderate persistent asthma
- Registration Number
- CTRI/2018/06/014543
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1Pre-dose Forced Expiratory Volume in 1 second (FEV1)Timepoint: 1Pre-dose Forced Expiratory Volume in 1 second (FEV1)
- Secondary Outcome Measures
Name Time Method Daytime asthma symptom scoreTimepoint: 12 weeks;Short-acting beta agonist (SABA) taken per day <br/ ><br>Timepoint: 12 weeks