Health Condition 1: null- Asthma Health Condition 2: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Symbicort pMDI: 2 actuations bid (morning and evening), for oral inhalation, 26-week treatment 2 actuations bid (morning and evening), for oral inhalation, 26-week treatment
Control Int
Sponsors
AstraZeneca AB
AstraZeneca Pharma India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal • Male or Female,more or equal 12 years of age • Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2 • Patient must have history of at least 1 asthma exacerbation including one of the following: o requiring treatment with systemic corticosteroids o an asthma-related hospitalization between 4 weeks and 12 months prior to randomization • Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire
Exclusion criteria
Exclusion criteria: • Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support. • Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2 • Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable) • An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization • Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigators opinion, will interfere with the patients lung function • Patient must not meet unstable asthma severity criteria as listed in the protocol • Peak expiratory flow must not be below 50% o predicted normal • Pregnancy, breast-feeding or planned pregnancy during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to first event in composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization) 2. Time to first event included in the definition of asthma exacerbation (Asthma exacerbations, defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroidsTimepoint: 1. Up to 27 weeks 2. Up to 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percent of days with no asthma symptoms 2. Percent of days with no activity limitation due to asthma 3. Asthma Control Questionnaire (ACQ6)Timepoint: 1. daily up to 26 weeks 2. daily up to 26 weeks 3. baseline, day 28, day 84, day 182 | — |
Countries
Argentina, Brazil, Bulgaria, Chile, Colombia, Czech Republic, France, Germany, India, Italy, Mexico, Panama, Peru, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Slovakia, South Africa, Sweden, Thailand, Turkey, Ukraine, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactMs Ranju Sharma
AstraZeneca Pharma India Ltd.
Outcome results
None listed