Last updated on June 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Asthma
  • Age: Between 12 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Written informed consent and assent (if applicable).
  • Male and female patients aged 12 years (or lower age limit allowed by health authority and/or ethics committee/institutional review board approvals).
  • A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
  • Evidence of airway reversibility or airway hyper- reactivity.
  • FEV1 of 80% of the predicted normal value for patients aged 18 years; FEV1 of 90% for patients aged 12 to <18 years
  • An ACQ score 1.5.
  • A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

Exclusion Criteria:

  • Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
  • Subjects who have participated in another trial of QAW039.
  • A QTcF (Fridericia) 450 msec (male) or 460 msec (female).
  • History of malignancy with the exception of local basal cell carcinoma of the skin.
  • Pregnant or nursing (lactating) women.
  • Serious co-morbidities.
  • Patients on greater than 20 mg of simvastatin, greater than 40 mg of atorvastatin, greater than 40 mg of pravastatin, or greater than 2 mg of pitavastatin

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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