Study to Investigate the Efficacy of Symbicort® SMART.

Study Overview
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Brief Summary
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The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy

Official Title
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A Comparison of Symbicort® SMART (160/4.5μg) and Symbicort® Turbuhaler 160/4.5 μg, Plus Terbutaline Turbuhaler 0.4 mg as Needed, for Treatment of Asthma - a 12-month, Randomized, Double-blind, Parallel Group, Active-controlled, Multinational Phase III Study in Asthmatic Patients From 16 Years

Conditions
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Asthma

Intervention / Treatment
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* Drug: Symbicort Turbuhaler
* Drug: Terbutaline Turbuhaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA) 2007 with a documented history of at least 6 months duration. Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12 weeks. Exclusion Criteria: Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks. Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed | Drug: Symbicort Turbuhaler<br>* 160/4.5 µg<br>|
| Active Comparator: 2<br>Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed | Drug: Symbicort Turbuhaler<br>* 160/4.5 µg<br>Drug: Terbutaline Turbuhaler<br>* 0.4 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study | Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment. | week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Asthma Exacerbations | Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here. | up to 52 weeks | 
| Morning Peak Expiratory Flow (PEF) | The mean value from a 52-week treatment period. | 52-week treatment period | 
| Evening PEF | The mean value from a 52-week treatment period. | 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period | 
| Forced Expiratory Volume in One Second (FEV1) | The mean value for Weeks 4, 12, 24, 36 and 52 was analysed. | 4, 12, 24, 36 and 52 weeks after randomization | 
| Use of As-needed Medication | The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time). | 52-week treatment period | 
| Asthma Symptom Score | The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst). | 52-week treatment period | 
| Nights With Awakening(s) Due to Asthma Symptoms | The mean value from the treatment period was presented here. | 52-week treatment period | 
| The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations | Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here. | up to 52 weeks | 
| Symptom-free Days (no Symptoms and no Awakenings) | A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here. | 52-week treatment period | 
| Percentage of As-needed-free Days | An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here. | 52-week treatment period | 
| Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use) | An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here. | 52-week treatment period | 
| Asthma Control Questionnaire (ACQ) | The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here. | 4, 12, 24, 36 and 52 weeks after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Symbicort Turbuhaler