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Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

NCT02555683 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 894

Last updated 2020-05-18

Study results available
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Summary

This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations:

* patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population)
* patients with inadequately controlled severe asthma (overall study population)

Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).

Conditions

Interventions

DRUG

QAW039

QAW039 150 mg once daily

DRUG

QAW039

QAW039 450 mg once daily

DRUG

Placebo

Placebo once daily

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-11
Primary Completion
2019-10-21
Completion
2019-11-04
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • China
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Guatemala
  • Hungary
  • Iceland
  • Ireland
  • Latvia
  • Lithuania
  • Philippines
  • Poland
  • Romania
  • Singapore
  • Spain
  • Switzerland
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02555683 on ClinicalTrials.gov