Effect of Anti-interleukin 5 (IL5) Therapy on Sputum Cells and Cytokines

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412044
• Other study ID #: s58608
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2016
• Est. completion date: March 1, 2019

Study information

• Verified date: May 2020
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

22 asthmatics, in which mepolizumab was to be started, gave permission for inclusion and were followed up prospectively. Clinical and lung functional data, sputum analyses and cytokine measurements were analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 1, 2019
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• FEV1 < 80% in the last 12 months

• use of high dose inhaled corticosteroids (ICS) in combination with other additional medication or continuous use of oral corticosteroids (OCS)

• at least 2 exacerbations in the last 12 months

• at least 300 blood eosinophils/µl once in the last 12 months and at the time of inclusion

• Anti-IL5 treatment prescribed by the physician

Exclusion Criteria:

• Not completing all visits

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Mepolizumab Injection [Nucala]
Patients receive monthly injection with 100 mg mepolizumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway inflammation	Bronchial airway inflammation. Differential cell count will be performed on sputum samples, determining eosinophilic (>3% eosinophils, <61% neutrophils), neutrophilic (<3% eosinophils and >61% neutrophils), pauci-granulocytic (<3% eosinophils and <61% neutrophils) and mixed granulocytic airway inflammation (>3% eosinophils and >61% neutrophils).	Day 1 and after 6 months
Primary	Change in Forced Expiratory Volume in 1 seconds (FEV1)	The forced expiratory Volume in 1 second will be measured using spirometry	Day 1 and after 6 months
Secondary	Cytokine pattern in the airways	Cytokines concentrations (pg/ml) will also be determined in sputum supernatant using a U-plex assay.	Day 1 and after 6 months
Secondary	Cytokine pattern in the bloodstream	Cytokines concentrations (pg/ml) will also be determined in serum using a U-plex assay.	Day 1 and after 6 months
Secondary	Change in asthma control	Asthma control will be determined using the Asthma Control Questionnaire (ACQ-6), including 6 questions. Each question will be scored from 0-6 and added together. This final score will be divided by the number of questions. If ACQ-6 < 0.75 = controlled asthma, ACQ-6 from 0.75-1.5 = partly controlled asthma and ACQ-6 > 1.5 = uncontrolled asthma.	Day 1 and after 6 months
Secondary	Biomarkers for airway inflammation	Fraction exhaled Nitric Oxid (FeNO) will be used as biomarker for eosinophilic airway inflammation. FeNO < 25 ppb = eosinophilic inflammation less likely, FeNO between 25 and 50 ppm = need further interpretation with additional clinical information, FeNO > 50 ppm = indication of eosinophilic airway inflammation (according to the American Thoracic Society guidelines)	Day 1 and after 6 months