Last updated on March 2020

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

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:

  • 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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.