A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: budesonide/formoterol 'as needed' + budesonide placebo bid; budesonode bid + terbutaline 'as needed'
Intervention description: Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment; Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment
Intervention MeSH terms: Budesonide; Terbutaline; Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4215.0
Sex: All
Minimum age: 12 Years
Maximum age: 130 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is
      effective in treating asthma when used 'as needed' in patients with milder asthma. The
      efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler
      twice daily plus terbutaline Turbuhaler 'as needed'
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of informed consent prior to any study specific procedures. For patients
             under-age, signed informed consent from both the patient and the patient's
             parent/legal guardian is required

          2. Male or Female, ≥12 years of age

          3. Documented diagnosis of asthma for at least 6 months prior to Visit 1

          4. Patients who are in need of GINA step 2 treatment

          5. Patients treated with a short acting inhaled bronchodilator(s) only should have
             pre-bronchodilator FEV1 ≥ 60 % of predicted normal (PN) and post-bronchodilator FEV1 ≥
             80 % PN

          6. Patients treated with low stable dose of ICS or leukotriene antagonists in addition to
             short acting inhaled bronchodilator(s) should have pre-bronchodilator FEV1 ≥80 % PN

          7. Patients should have reversible airway obstruction

          8. To be randomized patients must have used Bricanyl Turbuhaler as needed on at least 3
             separate days during the last week of the run in period

        Exclusion Criteria:

          1. Patient has a history of life-threatening asthma including intubation and intensive
             care unit admission

          2. Patient has had an asthma worsening requiring change in treatment other than short
             acting inhaled bronchodilator(s) within 30 days prior to Visit 1 and from Visit 1
             until randomization

          3. Patient has required treatment with oral, rectal or parenteral GCS within 30 days
             and/or depot parenteral GCS within 12 weeks prior to Visit 1

          4. Current or previous smoker with a smoking history of ≥ 10 pack years

          5. Pregnancy, breast-feeding or planned pregnancy during the study