Status:
COMPLETED
A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
12-130 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
12460 Patients enrolled
Trial Details
Trial ID
NCT01444430
Start Date
December 1 2011
End Date
October 1 2015
Last Update
December 15 2016
Active Locations (340)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Huntsville, Alabama, United States
3
Research Site
Anchorage, Alaska, United States
4
Research Site
Gilbert, Arizona, United States