Overview

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