NCT04195958: EDURO

A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma

Terminated Phase 4 Results posted Last updated 15 March 2022

What this trial tests

Phase 4 trial testing Omalizumab in Moderate-to-severe Allergic Asthma in 3 participants. Terminated before completion.

Timeline

30 November 2020

Primary endpoint
18 October 2021

18 October 2021

Quick facts

Lead sponsor	Genentech, Inc.
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	30 November 2020
Primary completion	18 October 2021
Estimated completion	18 October 2021
Sites	12 locations across United States

Drugs / interventions tested

• Omalizumab (omalizumab) — full drug profile →

Conditions studied

• Moderate-to-severe Allergic Asthma — all drugs for Moderate-to-severe Allergic Asthma →

Sponsor

Genentech, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Moderate-to-severe Allergic Asthma. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline to Week 28. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Omalizumab

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (1 terms — click to expand)

Reaction	System	Omalizumab
General Disorders	General disorders	—

Data from ClinicalTrials.gov NCT04195958 adverse events section.

Sponsor's own description

This study will assess the effect of omalizumab on exercise capacity, physical activity, and sleep quality after 24 weeks of treatment in participants with moderate to severe allergic asthma. Exercise capacity will be assessed using cardiopulmonary exercise testing (CPET). Physical activity and sleep quality will be assessed with a wearable physical activity and sleep monitor. The study will consist of a 4-week screening period, a 24-week treatment period, and a 4-week safety follow-up. Approximately 60 participants will be enrolled, and omalizumab will be dosed according to the approved United States Package Insert (USPI) dosing table.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Physical activity end-points in trials of chronic respiratory diseases: summary of evidence.
   Rist C, Karlsson N, Necander S, Da Silva CA. · · 2022 · cited 9× · PMID 35295234 · DOI 10.1183/23120541.00541-2021