Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

Novartis

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo; Drug: QAW039

Study type: Interventional

Funder types: Industry

Identifiers

NCT03226392

2017-001272-40 (EudraCT Number)

CQAW039A2317

Details and patient eligibility

About

A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.

Enrollment: 704 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
• Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or 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.
• FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18 years.
• 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.
• Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in period.
• Demonstrated reversible airway obstruction.
• Asthma control questionnaire (ACQ) score ≥ 1.5.

Exclusion criteria

• Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.

• A resting QTcF (Fridericia) ≥450 msec (male) or

  ≥460 msec (female).

• Pregnant or nursing (lactating) women.

• Serious co-morbidities.

• Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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704 participants in 2 patient groups, including a placebo group

QAW039

Active Comparator group

Description:

QAW039 once daily

Treatment:

Drug: QAW039

Placebo

Placebo Comparator group

Description:

Placebo once daily

Treatment:

Drug: Placebo