Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults

Study Overview
=================
Brief Summary
-----------------
This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).

Official Title
-----------------
A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 Micrograms, 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. Study SPAIN

Conditions
-----------------
Asthma, Bronchial

Intervention / Treatment
-----------------
* Drug: Symbicort (budesonide/formoterol) Turbuhaler
* Drug: Conventional treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9). Prescribed inhaled GCS at a dose of 400μg/day of budesonide (or equivalents)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 LABA or daily treatment with inhaled GCS alone (i.e. without LABA) A history of suboptimal asthma control the month prior to enrolment as judged by the investigator Use of ≥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 b-blocking agent, including eye-drops and oral GCS as maintenance treatment. Known or suspected hypersensitivity to study therapy or excipients. A history of smoking ≥ 10 pack years. Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Symbicort (budesonide/formoterol) Turbuhaler|nan|
|Drug: Conventional treatment|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Severe Asthma Exacerbation | Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days. | Baseline up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Severe Exacerbations | Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral (GCS) treatment for at least 3 days. | Baseline up to 6 months | 
| Mean Use of as Needed Medication | Mean use of as needed medication during the treatment period | Baseline up to 6 months | 
| Use of Inhaled Steroids | Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents) | Baseline up to 6 months | 
| Change in the Asthma Control Questionnaire(ACQ) Score | The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled) | Daily 14 days prior to each of visit 2-4 | 
| Peak Expiratory Flow (PEF) | Peak expiratory flow (PEF) | 6 months (end of the study) |