COPD
Conditions
Interventions
Mepolizumab 100 mg compared with placebo is given subcutaneously every 4 weeks as a liquid formulation in a pre-filled safety syringe injection. The study treatment period will be a minimum of 52 week
Sponsors
Okamasa Arisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -A peripheral blood eosinophil count of >=300 cells/uL from the hematology sample collected at Screening Visit 0; AND A documented historical blood eosinophil count of >=150/uL in the 12 months prior to Screening Visit 0. Participants with no documented historical blood eosinophil count of >=150 cells/uL must meet this threshold based on the Screening Visit 1 assessment in order to return for Randomization Visit 2. -Participants with a clinically documented history of COPD for at least 1 year -A measured pre- and post-salbutamol FEV1/FVC ratio of 20% and =10 pack-years at Screening
Exclusion criteria
Exclusion criteria: -Participants with a past history or concurrent diagnosis of asthma are excluded regardless of whether they have active or inactive disease. -Participants with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. -Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening -Participants with lung volume reduction surgery within the 12 months prior to Screening Visit 1. -Participation in the acute phase of a pulmonary rehabilitation program -Participants receiving treatment with oxygen more than 2 L/min at rest over 24 hrs. -Participants with a QT interval, from the ECG conducted at Screening Visit 1, corrected with Fridericia's formula (QTcF) >450 msec (or QTcF >480 msec in participants with bundle branch block). -Participants with other conditions that could lead to elevated eosinophils
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of mepolizumab 100 mg subcutaneous (SC) compared to placebo, given every 4 weeks in liquid formulation by safety syringe (SS) to COPD participants at high risk of exacerbations despite the use of optimized COPD maintenance therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate mepolizumab 100 mg SC compared to placebo given every 4 weeks in liquid formulation by SS on additional efficacy assessments, health related quality of life (HRQoL), health care utilization, and symptoms | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Republic of Korea, Spain, Sweden, Taiwan, UK, USA
Contacts
Public ContactArisa Okamasa
GlaxoSmithKline K.K.
Outcome results
None listed