Craving to Biologics Used in Severe Asthma

Asthma Clinical Trial

— CROCUS  

Official title:

Craving to Biologics Used in Severe Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05426538
• Other study ID #: CROCUS
• Status: Completed
• Start date: December 10, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: December 2021
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Some patients treated with biologics for severe asthma experience a craving to the next biological administration. This phenomenon has never been described before. In this study, the researchers aim to further elucidate the feeling of needing the next administration of a biologic for severe asthma.

Description:

Recent research by Kroes and colleagues on omalizumab levels has shown that approximately half of patients on long-term omalizumab therapy (>4 months) experience a subjective craving for the next dose. These patients had a need (Borg scale 3-10) for the next dose of biologic before the usual periodic dose, while other patients indicated that they had no or a low need (Borg scale 0-2) for the next dose at the usual dosing moment. This so-called 'craving' has not been described in the literature before. Patients in the high-requirement group had significantly lower median omalizumab trough levels than patients in the low-requirement group. There may be a relationship between blood levels of biologics and the need for the next dose. However, data is currently only available on the variability in serum trough levels of omalizumab, but not yet on the other biologics for asthma, some of which are administered as a fixed dose and some are dosed by body weight. No assays are currently available for blood level determinations from the other biologics.

Before investigating the relationship between blood levels and the need for biologics, it is important to fully map the 'craving'. Some patients who are responders to biologic therapy based on improvements in clinical outcomes still do not have good enough control of their asthma and indicate that the dosing interval is not optimal. In addition to patients that indicate a need for the next dose, there are also patients that would like a longer dosing interval. To date, dosing interval adjustments have been made based on the patient's subjective experience and the physician's clinical judgment. This study investigates how big the problem of need for the next dose is, how patients experience this need, what this need exactly entails, whether this occurs more often in patients treated for a longer period and what possible problems patients experience in the treatment with biologics against serious problems.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Treated with a biologic for severe asthma in the Medical Centre Leeuwarden for more than 4 months

Exclusion Criteria:

• Not speaking Dutch

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Netherlands	Medical Centre Leeuwarden	Leeuwarden	Friesland

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of craving to the next biologic administration.	Craving will be assessed as a BORG-scale score >2. This scale ranges from 0 (No craving at all) to 10 (Extreme craving).	6 months
Primary	The character of craving to the next biologic administration.	This will be assessed by scoring the prevalence of asthma-related symptoms in patients reporting a craving. Craving will be assessed as a BORG-scale score >2. This scale ranges from 0 (No craving at all) to 10 (Extreme craving).	6 months
Secondary	Differences in craving (BORG-scale 0-10) between patients treated for more or less than 1 year.	Craving will be assessed with a BORG-scale score. This scale ranges from 0 (No craving at all) to 10 (Extreme craving).	6 months
Secondary	Differences in craving (BORG-scale 0-10) between patients with different biologics.	Craving will be assessed with a BORG-scale score. This scale ranges from 0 (No craving at all) to 10 (Extreme craving).	6 months
Secondary	Any other issues regarding the craving/administration of biologics for severe asthma, based on patient-level input from interviews.		6 months