Local Phase 4 Pan-European SMART Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide/formoterol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at out-patient clinics >18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief Exclusion Criteria: Asthma exacerbation within the last 14 days prior to study start subject aged >40 years with a smoking history of >10pack-years subjects with chronic obstructive lung disease or other significant respiratory disease

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Budesonide/formoterol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Severe Asthma Exacerbations Per Participant. | Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of Participants With Severe Asthma Exacerbation | The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. | 6 months. | 
| Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment. | A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant | 6 months. | 
| Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation | Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. | 6 months. | 
| Mean Daily Number of Inhalations of As-needed Medication. | The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment. | 4 weeks | 
| Percent of Participants With a Well Controlled Asthma Week. | The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use. | 6 months. | 
| Mean Overall Asthma Control Questionnaire (ACQ) Score | The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze. | 6 months. | 
| The Mean Total Daily Dose of Steroids From Symbicort. | The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose. | 4 weeks | 
| Mean Cost Per Participant Per Country | Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated. | 6 months | 

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