Trial Outcomes & Findings for 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 NCT04195958)
NCT ID: NCT04195958
Last Updated: 2022-03-15
Results Overview
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.
TERMINATED
PHASE4
3 participants
From Baseline to Week 24
2022-03-15
Participant Flow
This study was terminated by the Sponsor. Only 3 participants were enrolled in this study.
Participant milestones
| Measure |
Omalizumab
Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
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|---|---|
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Overall Study
STARTED
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3
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: From Baseline to Week 24Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline to Week 28Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline to Week 28Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Omalizumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omalizumab
n=3 participants at risk
Omalizumab was administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency was determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
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General disorders
General Disorders
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66.7%
2/3 • Number of events 2 • From Baseline to Week 28
AEs were collected at each participant contact. Severity of AEs was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER