Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults

• Status: Terminated
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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 study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).

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

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.