A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma
Condition: Moderate-to-severe Allergic Asthma
MeSH terms: Asthma
Intervention: Omalizumab
Intervention description: 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.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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