Local Phase 4 Pan-European SMART Study

Phase 4

Completed

• Conditions: Asthma

• Registration Number: NCT00463866
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-19
• Study First Submitted QC: 2007-04-19
• Study First Posted: 2007-04-20
• Study Completion: 2008-12
• Results First Submitted: 2009-12-22
• Status Verified: 2010-03
• Results First Submitted QC: 2010-03-08
• Last Update Submitted: 2010-03-08
• Results First Posted: 2010-03-22
• Last Update Posted: 2010-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8424

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Severe Asthma Exacerbations Per Participant.	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Fraction of Participants With Severe Asthma Exacerbation	6 months.	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.
Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation	6 months.	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.
Mean Daily Number of Inhalations of As-needed Medication.	4 weeks	The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.
Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.	6 months.	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
Percent of Participants With a Well Controlled Asthma Week.	6 months.	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.
Mean Overall Asthma Control Questionnaire (ACQ) Score	6 months.	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.
The Mean Total Daily Dose of Steroids From Symbicort.	4 weeks	The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.
Mean Cost Per Participant Per Country	6 months	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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Yaxley, United Kingdom