Status:
TERMINATED
Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults
Lead Sponsor:
AstraZeneca
Conditions:
Asthma, Bronchial
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The st...
Eligibility Criteria
Inclusion
- Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9).
- Prescribed inhaled GCS at a dose of 400μg/day of budesonide (or equivalents)and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
- Either daily maintenance treatment with both inhaled GCS and LABA or daily treatment with inhaled GCS alone (i.e. without LABA)
- A history of suboptimal asthma control the month prior to enrolment as judged by the investigator
- Use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment
Exclusion
- Previous treatment with Symbicort Single Inhaler;
- Use of any b-blocking agent, including eye-drops and oral GCS as maintenance treatment.
- Known or suspected hypersensitivity to study therapy or excipients.
- A history of smoking ≥ 10 pack years.
- Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
654 Patients enrolled
Trial Details
Trial ID
NCT00385593
Start Date
September 1 2006
End Date
October 1 2008
Last Update
December 16 2010
Active Locations (52)
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1
Research Site
A Coruña, Spain
2
Research Site
Alagón, Spain
3
Research Site
Alicante, Spain
4
Research Site
Almoradí, Spain