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

A Multicenter, Open-Label, Single-Arm Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Patients With Moderate to Severe Allergic Asthma

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.

Study Overview

• Status: Terminated
• Conditions: Moderate-to-severe Allergic Asthma
• Intervention / Treatment: Drug: Omalizumab

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Florida
    • Pembroke Pines, Florida, United States, 33024
      • Broward Research Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals & Clinics; Internal Medicine
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0934
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • New York
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • American Health Research Inc.
  • Ohio
    • Cleveland, Ohio, United States, 44016
      • University Hospitals Cleveland Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple Uni Medical Center; Pulmonary & Critical Care Medicine
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Physician-diagnosed asthma for at least 12 months prior to screening
• Documented history of positive skin test or in vitro reactivity to a perennial aeroallergen
• Able to comply with asthma control medication adherence, digital monitoring data collection, and eDiary requirements during screening period
• Able to safely complete incremental exercise tolerance at screening
• Pre-bronchodilator FEV1 of 40%-80% of predicted at screening
• Documented history of variable airflow obstruction or hyper-responsiveness within 12 months of study entry
• On inhaled corticosteroids (ICS) therapy at a total daily dose greater than or equal to (≥)500 micrograms (ug) of fluticasone propionate or equivalent and at least one second controller (LABA, LAMA, LTRA) for ≥3 months prior to screening
• Uncontrolled asthma during the screening period, defined as an ACQ-5 ≥0.75 score
• Sleep disturbance due to asthma (e.g. cough, wheezing etc.) in the opinion of the investigator
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to use adequate contraception during the treatment period and for 60 days after the final dose of study drug.

Exclusion Criteria:

• Known history of anaphylaxis/hypersensitivity to omalizumab
• Treatment with investigational drugs within 12 weeks or 5 half-lives (whichever is longer) prior to screening
• Treatment with monoclonal antibodies (e.g., omalizumab, mepolizumab, dupilumab) for 6 months prior to screening
• Maintenance oral corticosteroid therapy, defined as daily or alternate-day oral corticosteroid within 3 months prior to screening or during the screening period
• Treatment with systemic (oral, IV, or IM) corticosteroids within 4 weeks prior to screening or during the screening period
• Isolated diagnosis of exercise induced asthma without chronic symptoms
• History of interstitial lung disease, COPD, or other clinically significant lung disease other than asthma
• Current malignancy or history of malignancy within 5 years prior to screening
• Unable to complete cardiopulmonary exercise testing and/or perform physical activity due to underlying cardiac, neurologic or orthopedic conditions
• Ongoing physician-treated sleep disorder that is unrelated to asthma within 6 months prior to screening
• Current smoker or past smoker with >10 pack years
• Known HIV infection at screening
• Known acute or chronic infections with hepatitis C virus (HCV) and hepatitis B virus (HBV) at screening
• Infection that resulted in hospital admission, required treatment with intravenous or intramuscular antibiotics within 4 weeks prior to screening, or any active infection that required treatment with oral antibiotics within 2 weeks prior to screening
• Active tuberculosis requiring treatment within 12 months prior to screening
• History of alcohol, drug, or chemical abuse within 6 months of screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omalizumab	Drug: Omalizumab; Omalizumab will be administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency will be determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline at Week 24 in Endurance Time (Minutes) During Cardiopulmonary Exercise Testing (CPET) at a Constant Work Rate (CWR)	This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.	From Baseline to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline at Week 24 in Physical Activity (Minutes/Day) as Assessed by a Wearable Physical Activity and Sleep Monitor	This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.	From Baseline to Week 24
Change From Baseline at Week 24 in Dynamic Hyperinflation at Isotime, as Measured by Inspiratory Capacity During CPET at a CWR	This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.	From Baseline to Week 24
Change From Baseline at Week 24 in Sleep Efficiency as Assessed by a Wearable Physical Activity and Sleep Monitor	This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.	From Baseline to Week 24
Percentage of Participants With Adverse Events	This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.	From Baseline to Week 28
Percentage of Participants With Serious Adverse Events	This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.	From Baseline to Week 28
Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab	This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.	From Baseline to Week 24

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Actual): October 18, 2021
• Study Completion (Actual): October 18, 2021

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: ML41615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No