None listed
Conditions
Interventions
The investigational product (IP) will be administered at the study centre every 4 weeks for the first 3 doses, and then every 4 or 8 weeks thereafter. After the first 3 doses, patients randomized to t
placebo (dummy) injections will be administered at the 4-week interim treatment visits in order to maintain the blind.
Sponsors
ASTRAZENECA PERU S.A.,
Eligibility
Age
12 Years to 75 Years
Inclusion criteria
Inclusion criteria: Male and female patients aged from 18 to 75 years with diagnosed asthma, willing to provide informed consent and requiring continuous treatment with high-dose inhaled corticosteroids (>500 mcg fluticasone dry powder formulation equivalents total daily dose) and long-acting β2 agonists with or without additional maintenance asthma controller medications. Inclusion criteria detailed in page 24 of protocol in english, not enough space to include them all in this section.
Exclusion criteria
Exclusion criteria: 1.Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome) 2.Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: - Affect the safety of the patient throughout the study - Influence the findings of the studies or their interpretations - Impede the patient’s ability to complete the entire duration of study 3.Known history of allergy or reaction to the investigational product formulation 4.History of anaphylaxis to any biologic therapy 5.A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy Rest of exclusion criteria detailed in page 26 of protocol in english, not enough space to include them all in this section.
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Czech Republic, France, Germany, Italy, Japan, Mexico, Netherlands, Romania, South Africa, Spain, Sweden, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactUrsula Rodriguez
ASTRAZENECA PERU S.A.
Outcome results
None listed