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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Moderate-to-severe Allergic Asthma

Intervention / Treatment
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* Drug: Omalizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omalizumab<br> | Drug: Omalizumab<br>* 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.<br>|

What is the study measuring?
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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 |