A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate; Salmeterol Xinafoate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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