Systemic Corticosteroids Avoidance Study in Severe Asthma Patients
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo once daily; QAW039 150 mg once daily; QAW039 450 mg once daily
Intervention description: Placebo to QAW039 once daily (one tablet blinded placebo to QAW039 150 mg and one tablet blinded placebo to QAW039 450 mg).; QAW039 150 mg once daily (one tablet of blinded QAW039 150 mg to be given together with one tablet blinded placebo to QAW039 450 mg); QAW039 450 mg once daily (one tablet of blinded QAW039 450 mg to be given together with one tablet blinded placebo to QAW039 150 mg)
Intervention MeSH terms: Indoleacetic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 604.0
Sex: All
Minimum age: 18 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases; Obstructive Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity; Immune System Diseases; Fevipiprant; QAW039

Summary:

      The overall purpose of this study was to determine the efficacy of fevipiprant (150 mg and
      450 mg once daily), compared with placebo, as add-on to standard-of-care asthma therapy, in
      terms of avoidance of corticosteroid use over 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of asthma for a period of at least 3 months prior to
             Screening Visit with current asthma severity step 4 or 5 (GINA 2018)

          -  Currently on treatment with medium or high dose ICS/LABA +/- other controller
             (i.e.long-acting muscarinic antagonist (LAMA), leukotriene receptor antagonist (LTRA)
             etc. as per GINA) for a minimum of 6 weeks prior to Screening Visit

          -  At screening, patients with FEV1 of ≤80% of the predicted normal value for the
             patient, after withholding bronchodilators at Screening Visit and beginning of Run-In
             Visit

          -  An increase of ≥12% and ≥200 ml in FEV1 approximately 10 to 15 minutes after
             administration of 400 mcg of salbutamol/albuterol prior to randomization (documented
             historical reversibility was accepted).

          -  Demonstration of inadequate control of asthma based on an ACQ-5 score ≥1.5 at
             Screening Visit and Treatment Day 1 Visit

          -  Documented history of at least 1 asthma exacerbation within 1 year prior to enrollment

        Exclusion Criteria:

          -  Asthma exacerbation, within 6 weeks prior to enrollment (screening) that required SCS,
             hospitalization, or emergency room visit

          -  Chronic/maintenance use of oral corticosteroids (OCS) for asthma (total OCS use days
             greater than 6 months; continuously or intermittently) within the last year

          -  Prior use of biologics that has potential to interfere/ affect asthma disease
             progression, in the previous 6 months from run-in period.

          -  Any contraindications of SCS use e.g. diabetes, narrow angle glaucoma, or any other as
             defined by the treating physician

          -  Pregnant or nursing (lactating) women

          -  Use of other investigational drugs within 5 half-lives of enrollment, or [within 30
             days], whichever is longer