Persistent asthma. MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: Symbicort Turbuhaler 160/4.5 micrograms
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: budesonide
CAS Number: CAS-51333-22
Current Sponsor code: D5890L00022
Concentration un
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Visit 1 Provision of informed consent. Adult outpatients with a minimum of 6 months history of persistent asthma. Use of IGCS for at leat one month with the same daily dose of at least 500ug beclamethasone, 400ug budesonide, 200ug fluticasone, 400ug mometasone, 250ug beclomethasone, 250ug beclomethasone ultrafine particles or 320ug 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
Exclusion criteria
Exclusion criteria: 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, including eye-drops. 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. Subjects with COPD or other significant respiratory disease as judged by investigator. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare efficacy of Symbicort Maintenace and Reliever Therapy (Symbicort SMART) administered over 6 months at two different maintenance doses in adult asthmatic subjects on IGCS: 1 inhalation Symbicort 160/4.5 ug BD or 2 inhalations Symbicort 160/4.5 ug BD. ;Secondary Objective: To compare the cost-effectiveness of Symbicort SMART at two different maintenance doses. To assess the safety of Symbicort SMART at two different maintenance doses. To investigate whether or not subject characteristics at study entry predict which subjects benefit from a higher maintenance dose.;Primary end point(s): Time to first severe asthma exacerbation defined as deterioration in asthma leading to need for oral/systemic glucocorticosteroids for at least 3 days and/or need for hospitalisation/ermergency room visit because of asthma requiring oral/systemics glucocorticosteroids, or equivalent. | — |
Countries
Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed