No registrations found.
ID
Source
Brief title
Health condition
Allergic Asthma
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of patients with a ratio omalizumab trough-level to baseline IgE larger than 15:1
Secondary outcome
Association of the ratio omalizumab trough-level to baseline IgE and patients yearn for the next gift
Association of the ratio omalizumab trough-level to baseline IgE and asthma-related outcomes (ACQ, AQLQ, FEV1, NO)
Background summary
Omalizumab has been used in the treatment of severe allergic asthma for several years. Early trials found that adequate suppression of IgE was achieved when omalizumab was in excess over IgE 15:1. It remains unknown what this ratio is in patients treated for more than a year. Furthermore, some patients are able to extend their dose-interval, while some patients indicate that they yearn for their next omalizumab gift. In this trial the ratio between trough omalizumab-level and baseline IgE will be examined. The patients yearn for the next gift and the correlation with the ratio between trough omalizumab-level and baseline IgE will be examined.
Study objective
Our hypothesis is that the ratio omalizumab trough-level to baseline IgE differs from the 15:1 ratio, which was found to induce adequate asthma-suppression in early trials.
The patients yearn for the next gift may be associated with an inadequate ratio.
Study design
Data will be collected during the 6-month evaluation
Intervention
N/A
Inclusion criteria
Severe asthma patients, receiving more than 12 months of omalizumab therapy, >18 months old, able to sign informed consent.
Exclusion criteria
None
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7794 |
| Other | RTPO Leeuwarden : nWMO 375 |