Craving to Biologics Used in Severe Asthma

NCT05426538 | Completed

• 1 other identifier: CROCUS
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

Biological treatment; Patient-reported outcome measures; Treatment evaluation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Differences in craving (BORG-scale 0-10) between patients treated for more or less than 1 year.

  6 months

• Differences in craving (BORG-scale 0-10) between patients with different biologics.

  6 months

• Any other issues regarding the craving/administration of biologics for severe asthma, based on patient-level input from interviews.

  6 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Not speaking Dutch

Sponsors & Collaborators

• Frisius Medisch Centrum: lead

Study Sites (1)

Medical Centre Leeuwarden

Leeuwarden, Provincie Friesland, 8934AD, Netherlands

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: June 22, 2022
• Study Start: December 10, 2021
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 24, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)