NCT01463644

Mepolizumab in Chronic Obstructive Pulmonary Diseases (COPD) With Eosinophilic Bronchitis

Mepolizumab in COPD With Eosinophilic Bronchitis: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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?

Detailed description

It is thus likely that a specific treatment such as anti-IL5 directed against eosinophils would be superior to the current standard treatment in decreasing sputum eosinophil counts and exacerbations and decrease structural changes (remodelling) in patients with COPD who continue to have eosinophils in their airway and whose airway disease has an eosinophil-driven component as evidenced by persistent airway eosinophilia.

Conditions

• Chronic Obstructive Pulmonary Diseases
• Chronic Airways Limitation
• Bronchitis

Interventions

Type	Name	Description
DRUG	Mepolizumab	This is an anti IL-5 which is given once a month intravenously at the dose of 750 mg.
DRUG	placebo	The placebo will consist of 100 mL normal saline solution (0.9%, 154 mmol/L sodium chloride).

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2011-11-02
• Last updated: 2025-09-24
• Results posted: 2025-09-24

Locations

1 site across 1 country: Canada