A Pan-European, open label, randomised study comparing the efficacy and cost-effectiveness of Symbicort Maintenance and Reliever Therapy (Symbicort SMART) using a maintenance dose of Symbicort 160/4.5 micrograms of 1 or 2 inhalations twice daily in the treatment of persistent asthma. EUROSMART - EUROSMART
- Conditions
- Persistent asthma.MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2006-006512-30-DE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 8250
Visit 1
Provision of informed consent.
Adult outpatients with a minimum of 6 months history of persistent asthma.
Use of IGCS for at least one month with the same daily dose of at least 500µg beclomethasone, 400µg budesonide (metered dose), 200µg fluticasone, 400µg mometasone, 250µg beclomethasone ultrafine particles or 320µg ciclesonide.
Subjects with a history of use of SABAs for symptom relief during the previous 30 days.
Visit 2:
Use of at least one as needed inhalation for symptom relief on at least 4 of the last 7 days of the run-in period for subjects treated with IGCS without LABA and on at least 2 of the last 7 days of the run-in period for subjects treated with IGCS and LABA.
No severe asthma exacerbation during run-in period. No change in asthma maintenance treatment during run-in period
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects currently treated with Symbicort SMART
Known or suspected hypersensitivity to study therapy or excipients of the IMP including lactose
Asthma exacerbation within the last 14 days prior to visit 1
Subjects using oral, rectal or parenteral GCS during the last 14 days prior to visit 1.
Use of any beta-blocking agents.
Use of systemic treatment with potent CYP3A4 inhibitors.
Subjects treated with omazilumab, nebublised bronchodilators and/or nebulised glucocorticosteroids.
Subjects aged over >40 years with a smoking history of more than 10 pack-years. Additionally current smokers cannot be included in the NO subgroup due to the decrease of NO levels caused by smoking, but can be included in the main study.
Preganancy, breast-feeding or planned pregnancy during the study.
Suspected poor capability to follow instructions of the study.
Participation in a clinical study during last 30 days.
Planned hosptialisation during study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method