Systemic Corticosteroids Avoidance Study in Severe Asthma Patients

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT03629249

Run by

Novartis Pharmaceuticals

People needed

604

Starts

2018-12-13

Expected to finish

2020-02-06

Last updated by the study team

2021-10-11

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Westminster, California, United States
• Novartis Investigative Site — Winter Park, Florida, United States
• Novartis Investigative Site — Bangor, Maine, United States
• Novartis Investigative Site — Waldorf, Maryland, United States
• Novartis Investigative Site — The Bronx, New York, United States
• Novartis Investigative Site — Boerne, Texas, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — McKinney, Texas, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Florida, Buenos Aires, Argentina
• Novartis Investigative Site — Mar del Plata, Buenos Aires, Argentina
• Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
• Novartis Investigative Site — San Miguel de Tucumán, Tucumán Province, Argentina
• Novartis Investigative Site — San Miguel de Tucumán, Tucumán Province, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Argentina
• Novartis Investigative Site — Córdoba, Argentina
• Novartis Investigative Site — Erpent, Belgium
• Novartis Investigative Site — Lebbeke, Belgium
• Novartis Investigative Site — Newport Beach, California, United States

Full record on ClinicalTrials.gov

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