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NCT04195958 · ClinicalTrials.gov registry record · Phase 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
A Phase 4 study, sponsored by Genentech.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT04195958 is a Phase 4 study that was terminated before completion, run by Genentech. The registered enrollment target is 3 participants.
The verdict
NCT04195958, a Phase 4 study, was terminated before completion, sponsored by Genentech.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study 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.
Interventions
- DRUG Omalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2020-11-30 |
| Est. Completion | 2021-10-18 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04195958
The ClinicalTrials.gov registry entry for NCT04195958 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Omalizumab is the first listed.
NCT04195958 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04195958 about?
NCT04195958 is a clinical study titled "A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma". 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 slee...
What is the current status of trial NCT04195958?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2020-11-30. Estimated completion is 2021-10-18.
What interventions are being tested in trial NCT04195958?
The interventions under investigation include: Omalizumab (DRUG).
Who is sponsoring clinical trial NCT04195958?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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