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; terbutaline 'as needed' + placebo budesonide bid; budesonide 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; Terbutaline 0.4 mg powder for inhalation 'as needed' plus placebo Pulmicort (budesonide) 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: 3850.0
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: 1) terbutaline Turbuhaler® 'as
      needed' and with 2) 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
        Step 2 treatment according to Global Initiative for Asthma guidelines 5. Patients treated
        with 'as needed' inhaled short-acting bronchodilator(s) only should have pre-bronchodilator
        Forced Expiratory Volume in one second (FEV1) ≥ 60 % of Predicted Normal (PN) and
        post-bronchodilator FEV1 ≥ 80 % PN 6. Patients treated with low stable dose of inhaled
        corticosteroid or leukotriene antagonist in addition to 'as needed' use of inhaled
        short-acting 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 inhaled short-acting bronchodilator(s) within 30
        days prior to Visit 1 or between Visits 1 and 2; or a treatment other than Bricanyl
        Turbuhaler from Visit 2 until randomization 3. Patient has required treatment with oral,
        rectal or parenteral glucocorticosteroids (GCS) within 30 days and/or depot parenteral GCS
        within 12 weeks prior to Visit 1 4. Smoker (current or previous) with a smoking history of
        ≥ 10 pack years 5. Pregnancy, breast-feeding or planned pregnancy during the study.