Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05426538
Other study ID # CROCUS
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device