A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma
Public ClinicalTrials.gov record NCT04195958. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open-Label, Single-Arm Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Patients With Moderate to Severe Allergic Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04195958
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 3 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2020 (Actual)
- Primary completion
- Oct 18, 2021 (Actual)
- Completion
- Oct 18, 2021 (Actual)
- Last update posted
- Mar 15, 2022
2020 – 2021
United States locations
- U.S. sites
- 12
- U.S. states
- 12
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| Broward Research Center | Pembroke Pines | Florida | 33024 | — |
| University of Iowa Hospitals & Clinics; Internal Medicine | Iowa City | Iowa | 52242 | — |
| University of Michigan | Ann Arbor | Michigan | 48109-0934 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| Lenox Hill Hospital | New York | New York | 10075 | — |
| American Health Research Inc. | Charlotte | North Carolina | 28277 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44016 | — |
| Temple Uni Medical Center; Pulmonary & Critical Care Medicine | Philadelphia | Pennsylvania | 19140 | — |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | — |
| Swedish Health Services | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04195958, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 15, 2022 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04195958 live on ClinicalTrials.gov.