At a glance
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Mepolizumab in COPD With Eosinophilic Bronchitis: A Randomized Clinical Trial
In Brief
A Phase 3 clinical trial evaluating Mepolizumab and placebo for Chronic Obstructive Pulmonary Diseases and 2 related conditions. Completed, enrolled 18 participants across 1 site.
Detailed Summary
Some patients with chronic obstructive pulmonary diseases (COPD) have large number of specific white blood cells called eosinophils in their airways. These cells are also responsible for causing episodes of worsened respiratory symptoms (exacerbations) and often cause irreversible damage to the airways . This subset of COPD patients often require oral steroids to bring down the number of eosinophils in their airways. Steroids have harmful effects on several of our body systems like bones, blood pressure, blood glucose control and can cause recurrent infections. Mepolizumab is a drug that specifically targets eosinophils reducing the number in the airway. This drug has been shown to be effective in decreasing exacerbation rates and time to exacerbation in asthma patients with eosinophils in their airways. Targeting eosinophils in COPD patients has been shown to reduce severe exacerbations. Hence it is likely that COPD patients with eosinophils in their airways will benefit similarly and have reduced rates and time to exacerbation. Study Hypothesis:Does mepolizumab decrease sputum eosinophils in patients with fixed airflow obstruction (COPD) and eosinophilic bronchitis?
Study Details
Timeline
Interventions
This is an anti IL-5 which is given once a month intravenously at the dose of 750 mg.
The placebo will consist of 100 mL normal saline solution (0.9%, 154 mmol/L sodium chloride).