Non-interventional Surveillance of Effectiveness of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Moderate and Severe Asthma
Overview[ - collapse ][ - ]
Purpose | This is a 3-month non-interventional, observational study on patients with moderate and severe asthma. |
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Condition | Asthma |
Intervention | Drug: Symbicort |
Phase | N/A |
Sponsor | AstraZeneca |
Responsible Party | AstraZeneca |
ClinicalTrials.gov Identifier | NCT00573222 |
First Received | December 13, 2007 |
Last Updated | November 30, 2010 |
Last verified | November 2010 |
Tracking Information[ + expand ][ + ]
First Received Date | December 13, 2007 |
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Last Updated Date | November 30, 2010 |
Start Date | November 2007 |
Estimated Primary Completion Date | May 2008 |
Current Primary Outcome Measures | To evaluate & describe asthma control in adult patients w/moderate to severe asthma treated w/Symbicort SMART following the frequency, type & severity of symptoms through the Asthma Control Questionnaire. |
Current Secondary Outcome Measures | to evaluate the safety of Symbicort SMART treatment through the number and type of reported adverse events 2. assessment of patient's satisfaction with the treatment 3.assessment of physician's satisfaction with the treatment |
Descriptive Information[ + expand ][ + ]
Brief Title | Non-interventional Surveillance of Effectiveness of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Moderate and Severe Asthma |
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Official Title | Non-interventional Surveillance of Effectiveness of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Moderate and Severe Asthma |
Brief Summary | This is a 3-month non-interventional, observational study on patients with moderate and severe asthma. |
Detailed Description | Not Provided |
Study Type | Observational |
Study Phase | N/A |
Study Design | Time Perspective: Prospective |
Condition | Asthma |
Intervention | Drug: Symbicort |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 330 |
Estimated Completion Date | May 2008 |
Estimated Primary Completion Date | May 2008 |
Eligibility Criteria | Inclusion Criteria: - Patients with moderate and severe asthma on Symbicort SMART treatment Exclusion Criteria: - Under 18 years old |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Croatia |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00573222 |
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Other Study ID Numbers | NIS-RHR-SYM-2007/1 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | AstraZeneca |
Study Sponsor | AstraZeneca |
Collaborators | Not Provided |
Investigators | Study Director: Anan Marija Gjurovic AstraZeneca |
Verification Date | November 2010 |
Locations[ + expand ][ + ]
Research Site | Cakovec, Croatia |
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Research Site | Dubrovnik, Croatia |
Research Site | Osijek, Croatia |
Research Site | Pozega, Croatia |
Research Site | Pula, Croatia |
Research Site | Rijeka, Croatia |
Research Site | Senj, Croatia |
Research Site | Sibenik, Croatia |
Research Site | Slavonskibrod, Croatia |
Research Site | Vinkovci, Croatia |
Research Site | Vukovar, Croatia |
Croatia | Zadar, Croatia |
Research Site | Zagreb, Croatia |