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

NCT ID: NCT04195958

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2021-10-18

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.

Conditions

Moderate-to-severe Allergic Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Omalizumab

Group Type: EXPERIMENTAL

Omalizumab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Peninsula Research Associates

Rolling Hills Estates, California, United States

National Jewish Health

Denver, Colorado, United States

Broward Research Center

Pembroke Pines, Florida, United States

University of Iowa Hospitals & Clinics; Internal Medicine

Iowa City, Iowa, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Lenox Hill Hospital

New York, New York, United States

American Health Research Inc.

Charlotte, North Carolina, 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

Swedish Health Services

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ML41615

Identifier Type: -

Identifier Source: org_study_id