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.
ConditionAsthma
InterventionDrug: Symbicort
PhaseN/A
SponsorAstraZeneca
Responsible PartyAstraZeneca
ClinicalTrials.gov IdentifierNCT00573222
First ReceivedDecember 13, 2007
Last UpdatedNovember 30, 2010
Last verifiedNovember 2010

Tracking Information[ + expand ][ + ]

First Received DateDecember 13, 2007
Last Updated DateNovember 30, 2010
Start DateNovember 2007
Estimated Primary Completion DateMay 2008
Current Primary Outcome MeasuresTo 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 Measuresto 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 TitleNon-interventional Surveillance of Effectiveness of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Moderate and Severe Asthma
Official TitleNon-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 DescriptionNot Provided
Study TypeObservational
Study PhaseN/A
Study DesignTime Perspective: Prospective
ConditionAsthma
InterventionDrug: Symbicort
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment330
Estimated Completion DateMay 2008
Estimated Primary Completion DateMay 2008
Eligibility Criteria
Inclusion Criteria:

- Patients with moderate and severe asthma on Symbicort SMART treatment

Exclusion Criteria:

- Under 18 years old
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesCroatia

Administrative Information[ + expand ][ + ]

NCT Number NCT00573222
Other Study ID NumbersNIS-RHR-SYM-2007/1
Has Data Monitoring CommitteeNot Provided
Information Provided ByAstraZeneca
Study SponsorAstraZeneca
CollaboratorsNot Provided
Investigators Study Director: Anan Marija Gjurovic AstraZeneca
Verification DateNovember 2010

Locations[ + expand ][ + ]

Research Site
Cakovec, Croatia
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