A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents
Condition: Asthma
MeSH terms: Asthma
Intervention: Symbicort pMDI; budesonide pMDI
Intervention description: Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening), for oral inhalation.; Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening), for oral inhalation.
Intervention MeSH terms: Budesonide; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12460.0
Sex: All
Minimum age: 12 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Symbicort pMDI; Asthma; safety; budesonide

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
    

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