Asthma Clinical Trial
Official title:
A Comparison of the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus As-needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26 Weeks, Randomised, Open-label, Parallel-group, Multicentre Study
| Verified date | January 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Portugal: National Pharmacy and Medicines Institute |
| Study type | Interventional |
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | December 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: - - Diagnosis of asthma ³ 3 months - Prescribed daily use of glucocorticosteroids at a dose > 320 mcg/ day for at least 3 months prior to Visit 1 Exclusion Criteria: - Smoking history > 10 pack-years - Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion - Any significant disease or disorder that my jeopardize the safety of the patient. Additional inclusion and exclusion criteria will be evaluated by the investigator. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Chile | Research Site | Quillota | |
| Chile | Research Site | Valparaiso | |
| Croatia | Researh Site | Dubrovnik | |
| Croatia | Research Site | Split | |
| Croatia | Research Site | Zagreb | |
| Czech Republic | Research Site | Brno | |
| Czech Republic | Research Site | Hradec Králové | |
| Czech Republic | Research Site | Jihlava | |
| Czech Republic | Research Site | Litomice | |
| Czech Republic | Research Site | Ostrava | |
| Czech Republic | Research Site | Praha | |
| Czech Republic | Research Site | Prostijov | |
| Czech Republic | Research Site | Strakonice | |
| Greece | Research Site | Ahens | |
| Greece | Research Site | Alexandroup | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Kavala | |
| Iceland | Research Site | Akureyri | |
| Iceland | Research Site | Reykjavik | |
| Latvia | Research Site | Daugavpils | |
| Latvia | Research Site | Riga | |
| Latvia | Research Site | Rigas raj | |
| Lithuania | Research Site | Kaunas | |
| Lithuania | Research Site | Klaipeda | |
| Lithuania | Research Site | Vilnius | |
| Portugal | Research Site | Aveiro | |
| Portugal | Research Site | Coimbra | |
| Portugal | Research Site | Coviha | |
| Portugal | Research Site | Lisboa | |
| Portugal | Research Site | Porto | |
| Portugal | Research Site | Setubal | |
| Portugal | Research Site | Vila Nova de Gaia | |
| Slovakia | Research Site | Banská Bystrica | |
| Slovakia | Research Site | Bardejov | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Hlohovec | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Liptovský Hrádok | |
| Slovakia | Research Site | Malacky | |
| Slovakia | Research Site | Nitra Zobor | |
| Slovakia | Research Site | Partizánske | |
| Slovakia | Research Site | Revúca | |
| Slovakia | Research Site | Senec | |
| Slovakia | Research Site | Topostany | |
| Slovakia | Research Site | Zilina | |
| Slovenia | Research Site | Celje | |
| Slovenia | Research Site | Golnik | |
| Slovenia | Research Site | Kamnik | |
| Slovenia | Research Site | Koper | |
| Slovenia | Research Site | Litija | |
| Slovenia | Research Site | Ljubljana | |
| Slovenia | Research Site | Murska Sobota | |
| Slovenia | Research Site | Nova Gorica |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Chile, Croatia, Czech Republic, Greece, Iceland, Latvia, Lithuania, Portugal, Slovakia, Slovenia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to first severe asthma exacerbation | |||
| Secondary | Number of asthma exacerbations | |||
| Secondary | Mean use of as-needed medication | |||
| Secondary | Prescribed asthma medication | |||
| Secondary | Asthma Control Questionnaire | |||
| Secondary | Asthma related costs (direct asthma medication, direct non-medication costs and indirect costs) | |||
| Secondary | Safety: Serious Adverse Events and discontinuations due to adverse events | |||
| Secondary | All variables assessed over the 6 months treatment period |
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