A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Symbicort TBH - Turbuhaler; beta-II-agonist, inhale steroid
Intervention description: Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed); Salbulin inh. 200-400 dosage 100 microgram (mcg)/dosage Salbutamol Sustained Release(SR)capsule 4 mg/8 mg Salbutol tablet (tb) 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb, syrup, intravenous(IV),5mgx10 ampule(amp) Ventolin inhaler (inh) 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage
Intervention MeSH terms: Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate; Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 430.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Symbicort; Turbuhaler; Persistent Asthma

Summary:

      The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with
      treatment according to conventional best practice in adult patients with persistent asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent form. If the patient cannot read and write, verbal consent
             from the patient is required.

          -  Ability to read and write in Turkish

          -  Female or male outpatients aged 18 years

          -  Minimum of 3 months history of asthma, diagnosed according to the American Thoracic
             Society (ATS) definition

          -  Prescribed inhaled glucocorticosteroid (GCS) at a dose of 320mg/day and within the
             approved label for the relevant drug during the last 3 months prior to Visit 1

          -  Either: daily maintenance treatment with both inhaled GCS and long-acting b2-agonist
             (LABA) or daily treatment with inhaled GCS alone (i.e. without LABA); and a history of
             suboptimal asthma control the month prior to enrollment as judged by the investigator;
             and use of 3 Peak Expiratory Flow inhalations ofas needed medication for symptom
             relief during the last 7 days before enrollment

        Exclusion Criteria:

          -  Previous treatment with Symbicort Single inhaler Therapy

          -  Use of any b-blocking agent, including eye drops

          -  Use of oral GCS as maintenance treatment

          -  Known or suspected hypersensitivity to study therapy or excipients

          -  A history of smoking 10 pack years

          -  Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not
             using acceptable contraceptive measures, as judged by the investigator

          -  Any significant disease or disorder, which, in the opinion of the investigator, may
             put the patient at risk because of participating in the study