A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting β2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (≥12 Years of Age) Patients With Asthma
Overview
- Phase
- Phase 3
- Intervention
- Symbicort pMDI
- Conditions
- Asthma
- Sponsor
- AstraZeneca
- Enrollment
- 12460
- Locations
- 1
- Primary Endpoint
- Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma
Detailed Description
A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide) and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
- •Male or Female, ≥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:
- •requiring treatment with systemic corticosteroids
- •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
- •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 investigator's opinion, will interfere with the patient's 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
Arms & Interventions
1
Symbicort
Intervention: Symbicort pMDI
2
budesonide
Intervention: budesonide pMDI
Outcomes
Primary Outcomes
Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)
Time Frame: Up to 27 weeks
Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation
Time Frame: Up to 26 weeks
Number of participants experiencing an event included in the definition of asthma exacerbation. An asthma exacerbation was 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 corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
Secondary Outcomes
- Percent of Nights With Awakening(s) Due to Asthma(Daily up to 26 weeks)
- Percent of Days With no Asthma Symptoms(Daily up to 26 weeks)
- Mean Number of Puffs of Rescue Medication Per 24 Hours(Daily up to 26 weeks)
- Percent of Days With Activity Limitation Due to Asthma(Daily up to 26 weeks)
- Asthma Control Questionnaire (ACQ6)(baseline, day 28, day 84, day 182)
- Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation(Up to 26 weeks)