Asthma
Conditions
Sponsors
AstraZeneca KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, age 12 to 80 years - Documented physician-diagnosed asthma for at least 12 months - Evidence of asthma as documented by post BD (albuterol/salbutamol) reversibility of FEV1 12% or more AND 200 mL or more (15-60 min after administration of 4 puffs of albuterol/salbutamol), documented either: in the previous 12 months prior to V1, OR demonstrated at V1, V1A, or at V2. - Documented history of current treatment with medium- or high-dose ICS for at least 6 months and at least one additional asthma controller medication according to standard practice of care. ICS dose must be greater than or equal to 500 microgram/day fluticasone propionate dry powder formulation or equivalent daily - Morning pre-BD FEV1 of >50% predicted normal at Visit 1, Visit 1A, or Visit 2
Exclusion criteria
Exclusion criteria: - Clinically important pulmonary or systemic diseases other than asthma - History of cancer except basal cell carcinoma, squamous cell carcinoma, or in situ carcinoma of the cervix within 12 months prior to Visit 1 - Acute upper or lower respiratory infection requiring antibiotics or antiviral medications finalized 2 times upper limit of normal), ongoing liver disease or inexplicably elevated liver chemistry values - Pregnant, breastfeeding or lactating women - Non-leukocyte depleted whole blood transfusion in 120 days prior to visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy exploratory - | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy exploratory pharmacokinetics - | — |
Countries
Europe, Japan, North America
Outcome results
None listed