A Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With Eosinophilia

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title: A Multi-center, Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With Eosinophilia

Status Terminated

Clinical Trial Summary

This was an exploratory, randomized, subject- and investigator-blind, placebo-controlled, parallel group, proof-of-mechanism study of multiple oral doses of fevipiprant (QAW039) in chronic obstructive pulmonary disease (COPD) patients with eosinophilia.

Clinical Trial Description

This was an exploratory, randomized, subject- and investigator-blind, placebo-controlled, parallel group, proof-of-mechanism study in COPD subjects with eosinophilia, on standard of care therapy. Standard of care (SoC) treatment in subjects with COPD typically includes a regimen of inhaled corticosteroid (ICS) plus one or more long acting bronchodilator (long-acting beta2-agonist (LABA) or long-acting antimuscarinic antagonist (LAMA)).

The study consisted of a screening period (including an optional pre-screen visit) during which the subject's phenotype and eligibility for the study were assessed. All subjects who met the eligibility criteria after the screening visit were to undergo induction of their sputum to examine the baseline sputum cell counts. Subjects were required to demonstrate both blood and sputum eosinophilia to be eligible for participation in the study.

Eligible subjects were randomized 3:2 to active (fevipiprant 450 mg oral daily) vs. placebo arms. Randomization was stratified by current smoking status (current vs. ex-smoker). Subjects were to continue their COPD standard of care and other medications during the entire course of the study. Subjects were to receive multiple doses of fevipiprant or placebo for six weeks.

Sputum induction was to be repeated at the end of the treatment period and at the end of the study (approximately 4 weeks after the last dose).

The primary purpose of the proof-of-mechanism study was to determine whether fevipiprant (QAW039), when administered to COPD patients with eosinophilic airway inflammation on standard of care therapy, reduced the burden of sputum eosinophilia. Data from other trials did not confirm efficacy of fevipiprant and did not warrant the continuation of treatment in this study. As a result, this study was terminated early. ;

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Eosinophilia
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT03810183
• Study type: Interventional
• Source: Novartis
• Status: Terminated
• Phase: Phase 2
• Start date: May 21, 2019
• Completion date: January 16, 2020