A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Qua… (NCT04195958) | Clinical Trial Compass
TerminatedPhase 4
A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma
Stopped: Due to low enrollment, this study was terminated early.
United States3 participantsStarted 2020-11-30
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mon…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline at Week 24 in Endurance Time (Minutes) During Cardiopulmonary Exercise Testing (CPET) at a Constant Work Rate (CWR)