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

Phase 4

Terminated

Conditions: Moderate-to-severe Allergic Asthma

Interventions: Drug: Omalizumab

Registration Number: NCT04195958

Lead Sponsor: Genentech, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omalizumab	Omalizumab	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (12): Swedish Health Services
🇺🇸
Seattle, Washington, United States
Broward Research Center
🇺🇸
Pembroke Pines, Florida, United States
University Hospitals Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
Temple Uni Medical Center; Pulmonary & Critical Care Medicine
🇺🇸
Philadelphia, Pennsylvania, United States
Spartanburg Medical Research
🇺🇸
Spartanburg, South Carolina, United States
National Jewish Health
🇺🇸
Denver, Colorado, United States
Peninsula Research Associates
🇺🇸
Rolling Hills Estates, California, United States
University of Iowa Hospitals & Clinics; Internal Medicine
🇺🇸
Iowa City, Iowa, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Lenox Hill Hospital
🇺🇸
New York, New York, United States
American Health Research Inc.
🇺🇸
Charlotte, North Carolina, United States
Mayo Clinic - Rochester
🇺🇸
Rochester, Minnesota, United States