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

• Sponsor: Genentech, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04195958
• Collaborator: (none)
• Enrollment: 3
• Locations: 12
• Arm: 1
• Actual Duration (Months): 10.6
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Moderate-to-severe Allergic Asthma	Drug: Omalizumab	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Nov 30, 2020
• Actual Primary Completion Date: Oct 18, 2021
• Actual Study Completion Date: Oct 18, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline at Week 24 in Endurance Time (Minutes) During Cardiopulmonary Exercise Testing (CPET) at a Constant Work Rate (CWR) [From Baseline to Week 24]

   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.

Secondary Outcome Measures

1. Change From Baseline at Week 24 in Physical Activity (Minutes/Day) as Assessed by a Wearable Physical Activity and Sleep Monitor [From Baseline to Week 24]

   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.

2. Change From Baseline at Week 24 in Dynamic Hyperinflation at Isotime, as Measured by Inspiratory Capacity During CPET at a CWR [From Baseline to Week 24]

   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.

3. Change From Baseline at Week 24 in Sleep Efficiency as Assessed by a Wearable Physical Activity and Sleep Monitor [From Baseline to Week 24]

   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.

4. Percentage of Participants With Adverse Events [From Baseline to Week 28]

   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.

5. Percentage of Participants With Serious Adverse Events [From Baseline to Week 28]

   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.

6. Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab [From Baseline to Week 24]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Genentech, Inc.

Investigators

• Study Director: Clinical Trials, Genentech, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 11, 2020

More Information

Publications

None provided.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT04195958
• Other Study ID Numbers: ML41615
• First Posted: Dec 12, 2019
• Last Update Posted: Mar 15, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Asthma; Omalizumab

Study Results

Participant Flow

Pre-assignment Detail	This study was terminated by the Sponsor. Only 3 participants were enrolled in this study.

Arm/Group Title	Omalizumab
Arm/Group Description	Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
Period Title: Overall Study
STARTED	3
COMPLETED	1
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Omalizumab
Arm/Group Description	Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
Overall Participants	0
Age (Years) []
Sex: Female, Male () []
Female
Male
Race/Ethnicity, Customized () []

Outcome Measures

1. Primary Outcome

Title	Change From Baseline at Week 24 in Endurance Time (Minutes) During Cardiopulmonary Exercise Testing (CPET) at a Constant Work Rate (CWR)
Description	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.
Time Frame	From Baseline to Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Omalizumab
Arm/Group Description	Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
Measure Participants	0

2. Secondary Outcome

Title	Change From Baseline at Week 24 in Physical Activity (Minutes/Day) as Assessed by a Wearable Physical Activity and Sleep Monitor
Description	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.
Time Frame	From Baseline to Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Omalizumab
Arm/Group Description	Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
Measure Participants	0

3. Secondary Outcome

Title	Change From Baseline at Week 24 in Dynamic Hyperinflation at Isotime, as Measured by Inspiratory Capacity During CPET at a CWR
Description	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.
Time Frame	From Baseline to Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Omalizumab
Arm/Group Description	Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
Measure Participants	0

4. Secondary Outcome

Title	Change From Baseline at Week 24 in Sleep Efficiency as Assessed by a Wearable Physical Activity and Sleep Monitor
Description	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.
Time Frame	From Baseline to Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Omalizumab
Arm/Group Description	Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
Measure Participants	0

5. Secondary Outcome

Title	Percentage of Participants With Adverse Events
Description	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.
Time Frame	From Baseline to Week 28

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Omalizumab
Arm/Group Description	Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
Measure Participants	0

6. Secondary Outcome

Title	Percentage of Participants With Serious Adverse Events
Description	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.
Time Frame	From Baseline to Week 28

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Omalizumab
Arm/Group Description	Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
Measure Participants	0

7. Secondary Outcome

Title	Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab
Description	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.
Time Frame	From Baseline to Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Omalizumab
Arm/Group Description	Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
Measure Participants	0

Adverse Events

Time Frame	From Baseline to Week 28
Adverse Event Reporting Description	AEs were collected at each participant contact. Severity of AEs was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Arm/Group Title	Omalizumab
Arm/Group Description	Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
All Cause Mortality
	Omalizumab
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Serious Adverse Events
	Omalizumab
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	Omalizumab
	Affected / at Risk (%)	# Events
Total	2/3 (66.7%)
General disorders
General Disorders	2/3 (66.7%)	2

Limitations/Caveats

This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on this, there were not enough participants enrolled to perform a meaningful analysis.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.