Clinical trial NCT04195958: A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Moderate-to-severe Allergic Asthma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-12
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline at Week 24 in Endurance Time (Minutes) During Cardiopulmonary Exercise Testing (CPET) at a Constant Work Rate (CWR)
timeFrame: From Baseline to Week 24
Secondary outcomes:
measure: Change From Baseline at Week 24 in Physical Activity (Minutes/Day) as Assessed by a Wearable Physical Activity and Sleep Monitor
timeFrame: From Baseline to Week 24
measure: Change From Baseline at Week 24 in Dynamic Hyperinflation at Isotime, as Measured by Inspiratory Capacity During CPET at a CWR
timeFrame: From Baseline to Week 24
measure: Change From Baseline at Week 24 in Sleep Efficiency as Assessed by a Wearable Physical Activity and Sleep Monitor
timeFrame: From Baseline to Week 24
measure: Percentage of Participants With Adverse Events
timeFrame: From Baseline to Week 28
measure: Percentage of Participants With Serious Adverse Events
timeFrame: From Baseline to Week 28
measure: Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab
timeFrame: From Baseline to Week 24
Other outcomes:
Locations:
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Pembroke Pines
country: United States
facility: Broward Research Center
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics; Internal Medicine
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Charlotte
country: United States
facility: American Health Research Inc.
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Temple Uni Medical Center; Pulmonary & Critical Care Medicine
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Seattle
country: United States
facility: Swedish Health Services
state: Washington
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: