AsthmaCROCUSNCT05426538
Craving to Biologics Used in Severe Asthma
An observational study of Asthma, run by Frisius Medisch Centrum at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Dec 2021to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Treated with a biologic for severe asthma in the Medical Centre Leeuwarden for more than 4 months
Who cannot join
- Not speaking Dutch
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Medical Centre Leeuwarden
Leeuwarden, Provincie Friesland, 8934AD
About this study
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.
Read the 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.
- Conditions
- Asthma
- Keywords
- Biological treatment, Patient-reported outcome measures, Treatment evaluation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 6 months
Secondary outcomes (3)
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).
Measured: 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).
Measured: 6 months
Any other issues regarding the craving/administration of biologics for severe asthma, based on patient-level input from interviews.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start10 Dec 2021
- Primary completion1 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426538
- Sponsor's protocol ID
- CROCUS
- Acronym
- CROCUS
- Status last verified
- Dec 2021
- First submitted
- 5 Jan 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual data will be shared, since data is collected in private interviews.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Craving to Biologics Used in Severe Asthma
- ClinicalTrials.gov ID
- NCT05426538
- Acronym / sponsor ID
- CROCUS / CROCUS
- Conditions
- Asthma
- Keywords
- Biological treatment, Patient-reported outcome measures, Treatment evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Treated with a biologic for severe asthma in the Medical Centre Leeuwarden for more than 4 months
Key exclusion criteria (1 listed)
- Not speaking Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of craving to the next biologic administration.
Time frame: 6 months
Craving will be assessed as a BORG-scale score >2. This scale ranges from 0 (No craving at all) to 10 (Extreme craving).
The character of craving to the next biologic administration.
Time frame: 6 months
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).
3 secondary outcomes
Differences in craving (BORG-scale 0-10) between patients treated for more or less than 1 year.
Time frame: 6 months
Differences in craving (BORG-scale 0-10) between patients with different biologics.
Time frame: 6 months
Any other issues regarding the craving/administration of biologics for severe asthma, based on patient-level input from interviews.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No. No individual data will be shared, since data is collected in private interviews.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Frisius Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of craving to the next biologic administration. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.