Systemic Corticosteroids Avoidance Study in Severe Asthma Patients

• Status: Terminated
• Trial end date: 2020-02-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Indoleacetic Acids

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