A new asthma drug candidate called fevipiprant

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Description

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.


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.LAMA, 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 is 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 enrolment

Exclusion Criteria:

  • Asthma exacerbation, within 6 weeks prior to enrolment (screening) that required SCS, hospitalization, or emergency room visit.
  • Chronic/ maintenance use of 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 contra-indications 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
  • Location

    New York

  • Sponsor

    Novartis

  • Trial ID

    NCT03629249

  • Condition Name

    Asthma

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ID-NCT03629249-v1-June 2019