Moderate/Severe Asthma Clinical Trial
Official title:
SMART Way of Treating Asthma. Non-interventional Study to Evaluate Clinical Efficacy of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Patients With Moderate and Severe Asthma
| Verified date | November 2010 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Romania: National Medicines Agency |
| Study type | Observational |
The primary objective of this non-interventional study is to evaluate efficacy of Symbicort® SMART treatment in adult patients with moderate to severe asthma using ACQ scores during 6 months period
| Status | Completed |
| Enrollment | 1182 |
| Est. completion date | October 2009 |
| Est. primary completion date | October 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patients eligible for entry into study are the patients diagnosed with moderate to severe asthma, that the doctors have already decided to treat with Symbicort SMART within the last month, before inclusion in this program - All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme. Exclusion Criteria: - All the patients who have a known hypersensitivity to Symbicort or any of its excipients will not be included in this study. - As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Romania | Research Site | Alba Iulia | |
| Romania | Research Site | Alexandria | |
| Romania | Research Site | Arad | |
| Romania | Research Site | Bacau | |
| Romania | Research Site | Baia Mare | |
| Romania | Research Site | Botosani | |
| Romania | Research Site | Braila | |
| Romania | Research Site | Brasov | |
| Romania | Research Site | Breaza | |
| Romania | Research Site | Bucuresti | |
| Romania | Research Site | Buftea | |
| Romania | Research Site | Calarasi | |
| Romania | Research Site | Campina | |
| Romania | Research Site | Campulung | |
| Romania | Research Site | Cluj Napoca | |
| Romania | Research Site | Constanta | |
| Romania | Research Site | Craiova | |
| Romania | Research Site | Deva | |
| Romania | Research Site | Drobeta Turnu Severin | |
| Romania | Research Site | Giurgiu | |
| Romania | Research Site | Hunedoara | |
| Romania | Research Site | Iasi | |
| Romania | Research Site | Leordeni | |
| Romania | Research Site | Miercurea Ciuc | |
| Romania | Research Site | Mizil | |
| Romania | Research Site | Oradea | |
| Romania | Research Site | Palazu Mare | |
| Romania | Research Site | Piatra Neamt | |
| Romania | Research Site | Pitesti | |
| Romania | Research Site | Ploiesti | |
| Romania | Research Site | Resita | |
| Romania | Research Site | Rm. Valcea | |
| Romania | Research Site | Scornicesti | |
| Romania | Research Site | Sf. Gheorghe | |
| Romania | Research Site | Sibiu | |
| Romania | Research Site | Slobozia | |
| Romania | Research Site | Suceava | |
| Romania | Research Site | Targoviste | |
| Romania | Research Site | Targu Mures | |
| Romania | Research Site | Tg. Jiu | |
| Romania | Research Site | Timisoara | |
| Romania | Research Site | Tulcea | |
| Romania | Research Site | Vaslui | |
| Romania | Research Site | Zalau |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Romania,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Asthma Control Questionnaire ACQ | 5 visits (V1-week 0, V2-week 4, V3-week 8, V4-week 16, V5-week 24) | No |