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OpenTrials
Completed

NCT Number: NCT04412044

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mepolizumab Injection [Nucala]

Drug

Patients receive monthly injection with 100 mg mepolizumab

Other names: Anti-IL5 treatment

Primary outcomes

  1. Airway inflammation

    Time frame: Day 1 and after 6 months

    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).

  2. Change in Forced Expiratory Volume in 1 seconds (FEV1)

    Time frame: Day 1 and after 6 months

    The forced expiratory Volume in 1 second will be measured using spirometry

Secondary outcomes

  1. Cytokine pattern in the airways

    Time frame: Day 1 and after 6 months

    Cytokines concentrations (pg/ml) will also be determined in sputum supernatant using a U-plex assay.

  2. Cytokine pattern in the bloodstream

    Time frame: Day 1 and after 6 months

    Cytokines concentrations (pg/ml) will also be determined in serum using a U-plex assay.

  3. Change in asthma control

    Time frame: Day 1 and after 6 months

    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.

  4. Biomarkers for airway inflammation

    Time frame: Day 1 and after 6 months

    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)

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jun 2, 2020
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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