About the study

The overall purpose of this study is to determine the efficacy of fevipiprant (dose 1 and dose 2 once daily), compared with placebo, as add-on to standard-of-care asthma therapy, in terms of avoidance of coricosteroid use over 52 weeks.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. 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)
2. Currently on treatment with medium or high dose ICS/LABA +/
3. other controller (i.e.LAMA, LTRA etc. as per GINA) for a minimum of 6 weeks prior to Screening Visit
4. 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 .
5. 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 is accepted).
6. Demonstration of inadequate control of asthma based on an ACQ-5 score ≥1.5 at Screening Visit and Treatment Day 1 Visit
7. Documented history of at least 1 asthma exacerbation within 1 year prior to enrolment

Exclusion criteria

1. Asthma exacerbation, within 6 weeks prior to enrolment (screening) that required SCS, hospitalization, or emergency room visit.
2. Chronic/ maintenance use of OCS for asthma ( total OCS use days greater than 6 months; continuously or intermittently) within the last year
3. Prior use of biologics that has potential to interfere/ affect asthma disease progression, in the previous 6 months from run-in period.
4. Any contra-indications of SCS use e.g. diabetes, narrow angle glaucoma, or any other as defined by the treating physician
5. Pregnant or nursing (lactating) women
6. Use of other investigational drugs within 5 half-lives of enrollment, or [within 30 days], whichever is longer

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.