Craving to Biologics Used in Severe Asthma (CROCUS)

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.

Study Overview

• Status: Completed
• Conditions: Asthma

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Netherlands
  • Friesland
    • Leeuwarden, Friesland, Netherlands, 8934AD
      • Medical Centre Leeuwarden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population concerns patients in the Medical Center Leeuwarden (MCL) with severe asthma who are treated with a biologic (omalizumab, mepolizumab, reslizumab, benralizumab or dupilumab) for more than 4 months.

A treatment duration longer than 4 months has been chosen, so that only responders to the biologics are included in the study and the therapy has its effect.

About 20 patients are interviewed. Subsequently, the questionnaire will be presented to approximately 30 patients per biologic, a total of approximately 150 patients.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Not speaking Dutch

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Interview group; A selection of patients will be interviewed, mapping the craving for the next biologic administration. These interviews will be used to develop a questionnaire to quantify the craving for the next administration in the total population.
Questionnaire group; The remaining patients will be asked to fill in a questionnaire, based on the interviews from Group 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Any other issues regarding the craving/administration of biologics for severe asthma, based on patient-level input from interviews.		6 months

Collaborators and Investigators

• Sponsor: Medical Centre Leeuwarden

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2021
• Primary Completion (ACTUAL): July 1, 2022
• Study Completion (ACTUAL): August 1, 2022

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (ACTUAL): June 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Biological treatment; Patient-reported outcome measures; Treatment evaluation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CROCUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual data will be shared, since data is collected in private interviews.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No