Mepolizumab for the Treatment of Chronic Cough With Eosinophilic Airways Diseases (NCT04765722) | Clinical Trial Compass
CompletedPhase 4
Mepolizumab for the Treatment of Chronic Cough With Eosinophilic Airways Diseases
Canada46 participantsStarted 2021-12-14
Plain-language summary
Cough is the most common presenting symptom to family physician. Chronic Cough affects approximately 10-12% of the general population and is one of the commonest reasons for referral to secondary care. Unfortunately, there are no licensed treatments for this debilitating condition, which is associated with a poor quality of life, affecting the social, physical and psychological well-being of patients.
The aim of this single-centre proof-of-concept study is to investigate whether mepolizumab reduces objective cough frequency in patients with eosinophilic asthma and non-asthmatic eosinophilic bronchitis presenting with chronic cough. Secondary outcomes including the effects on quality of life, the intensity of irritant sensations, airway hyper-reactivity and inflammatory cells and their progenitors will also be evaluated.
The investigators hypothesize that in patients with asthma and non-asthmatic eosinophilic bronchitis, eosinophils are involved in sensitizing airway nerves and thereby increasing spontaneous objective coughs. The investigators predict that treatment with mepolizumab will reduce airway eosinophilia in patients with chronic cough due to eosinophilic asthma and non-asthmatic eosinophilic bronchitis, thereby causing a reduction in objective cough frequency.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Aged ≥18
✓. Subjects with a history of chronic cough (cough lasting for \>8 weeks)
✓. Evidence of airway eosinophilia (sputum eosinophilia\>2%)
✓. Forced expiratory volume-1 ≥ 70% of predicted
✓. Normal chest x-ray (within the last 6 months)
✓. At least one dose of a COVID-19 vaccine a minimum of 2 weeks prior to enrollment
Exclusion criteria
✕. Symptoms of upper respiratory tract infection in the last 1 month which have not resolved.
✕. Lower respiratory tract infection or pneumonia in the last 1 month.
✕. Subjects with a positive covid-19 test within 2 weeks of screening
✕. Subjects with seasonal allergic rhinitis that affects their asthma control
What they're measuring
1
Change From Baseline in 24-hour Cough Frequency at 14 Weeks
. Current smoker or ex-smoker with ≥10 pack year smoking history and abstinence of ≤6 months
✕. Symptoms of uncontrolled asthma at screening defined as: Asthma Control Questionnaire-5 \>1.5, or use of 3 or more puffs of a short acting beta-2 agonist per week, or an exacerbation in the previous month requiring oral prednisone or antibiotics.
✕. Use of regular maintenance oral corticosteroids or long-acting muscarinic antagonist within 4 weeks prior to enrolment into the study.
✕. A previous asthma exacerbation requiring Intensive Care Unit admission.