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

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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

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

Trial documents
2

Trial contacts and locations

142

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Data sourced from clinicaltrials.gov

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