Status:
COMPLETED
A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adult patients with persistent asthma.
Detailed Description
A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.
Eligibility Criteria
Inclusion
- Signed informed consent form. If the patient cannot read and write, verbal consent from the patient is required.
- Ability to read and write in Turkish
- Female or male outpatients aged 18 years
- Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition
- Prescribed inhaled glucocorticosteroid (GCS) at a dose of 320mg/day 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 long-acting b2-agonist (LABA) or daily treatment with inhaled GCS alone (i.e. without LABA); and a history of suboptimal asthma control the month prior to enrollment as judged by the investigator; and use of 3 Peak Expiratory Flow inhalations ofas needed medication for symptom relief during the last 7 days before enrollment
Exclusion
- Previous treatment with Symbicort Single inhaler Therapy
- Use of any b-blocking agent, including eye drops
- Use of oral GCS as maintenance treatment
- Known or suspected hypersensitivity to study therapy or excipients
- A history of smoking 10 pack years
- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
- Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT00628758
Start Date
December 1 2005
End Date
September 1 2008
Last Update
August 14 2012
Active Locations (15)
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1
Research Site
Ankara, Turkey (Türkiye)
2
Research Site
Antalya, Turkey (Türkiye)
3
Research Site
Bursa, Turkey (Türkiye)
4
Research Site
Denizli, Turkey (Türkiye)