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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: Clinical Trial Phase 4 study, sponsored by Genentech.
NCT04195958 is a Phase 4 study that was terminated before completion, run by Genentech. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, no data is reported.
Interventions
- DRUG Omalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2020-11-30 |
| Est. Completion | 2021-10-18 |
| Phase | Phase 4 |
Why NCT04195958 stopped before completion
NCT04195958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Omalizumab is the first listed.
NCT04195958 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04195958's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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