Trial name or title	Study SPAIN A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 mcg, 1 Inhalation b.i. d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-Week, Randomised, Open-Label, Parallel-Group, Multicentre Study. Estimated enrolment: 1000
Methods	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Participants	Inclusion Criteria: Age 18 years or over Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9). Prescribed inhaled GCS at a dose of ?320 μg/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) A history of sub optimal asthma control the month prior to enrolment as judged by the investigator Use of at least 3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment Exclusion Criteria: Previous treatment with Symbicort Single Inhaler; Use of any beta-blocking agent, including eye-drops and oral GCS as maintenance treatment. Known or suspected hypersensitivity to study therapy or excipients. A history of smoking less than 10 pack years. Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
Interventions	A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 meg, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice
Outcomes	The primary outcome variable will be time to first severe asthma exacerbations. Exacerbations are considered an appropriate outcome variable by CPMP The definition of a severe asthma exacerbation is based on the same guideline A secondary objective is to collect safety data for treatment in the two treatment groups in adult patients with persistent asthma
Starting date	Sept 2006
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