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Systemic Corticosteroids Avoidance Study in Severe Asthma Patients

NCT03629249 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 604

Last updated 2021-10-11

Study results available
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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.

Conditions

Interventions

DRUG

Placebo once daily

Placebo to QAW039 once daily (one tablet blinded placebo to QAW039 150 mg and one tablet blinded placebo to QAW039 450 mg).

DRUG

QAW039 150 mg once daily

QAW039 150 mg once daily (one tablet of blinded QAW039 150 mg to be given together with one tablet blinded placebo to QAW039 450 mg)

DRUG

QAW039 450 mg once daily

QAW039 450 mg once daily (one tablet of blinded QAW039 450 mg to be given together with one tablet blinded placebo to QAW039 150 mg)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-13
Primary Completion
2020-02-06
Completion
2020-02-06
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Bulgaria
  • Chile
  • Colombia
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Peru
  • Philippines
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03629249 on ClinicalTrials.gov