None listed
Conditions
Interventions
At Visit 2 (Week 0) those subjects who successfully complete the run-in period as well as meet the other pre-defined eligibility criteria will be randomised to receive either add-on mepolizumab (100 m
study medication will be administered subcutaneously (SC) every 4 weeks for a total of 6 doses (Visit 2 to Visit 7, inclusive). The treatment period will conclude with subjects completing an assessmen
Sponsors
GlaxoSmithKline,
Eligibility
Age
12 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age: At least 12 years of age at the time of signing the informed consent/assent. [For those countries where local regulations permit enrolment of adults only, subject recruitment will be restricted to those who are 18 years of age] 2. Inhaled Corticosteroid: A well-documented requirement for regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS). 3. Controller Medication: Current treatment with an additional controller medication, besides ICS, for at least 3 months or a documented failure in the past 12 months of an additional controller medication for at least 3 successive months. [e.g., long-acting beta-2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline.] 4. Eosinophilic asthma: Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma as per Randomisation Criteria 1 and 2 5. FEV1: Persistent airflow obstruction as indicated by : • For subjects 18 years of age at visit 1, a pre-bronchodilator FEV1 <80% predicted (NHANES III) recorded at Visit 1 • For subjects 12-17 years of age at Visit 1: • A pre-bronchodilator FEV1 <90% predicted (NHANES III) recorded at Visit 1 OR • FEV1:FVC ratio < 0.8 recorded at Visit 1
Exclusion criteria
Exclusion criteria: 1. Smoking history: Current smokers or former smokers with a smoking history of 10 pack years (number of pack years = (number of cigarettes per day / 20) x number of years smoked). A former smoker is defined as a subject who quit smoking at least 6 months prior to Visit 1. 2. Concurrent Respiratory Disease: Presence of a known pre-existing, clinically important lung condition other than asthma. This includes current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer. 3. Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Subjects that had localized carcinoma of the skin which was resected for cure will not be excluded). 4. Liver Disease: Known, pre-existing, unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, and known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones). 5. Cardiovascular: Subjects who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment.
Countries
Argentina, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, France, Germany, Greece, Italy, Netherlands, Norway, Peru, Russian Federation, Slovakia, Spain, Ukraine, United Kindgdom, United States
Contacts
Public ContactNoelia Nathaly Contreras
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed