New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.

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

Details

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

Criteria

Inclusion Criteria:

• Male or female 12 years and above

• Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months

• Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal

• Patients with reversible airway obstruction

• Documented daily use of inhaled corticosteroids for ≥ 3 months

Exclusion Criteria:

• History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures during the 2 years prior to Visit 2

• Hospitalized during previous 6 months for asthma

• Required emergency treatment more than once during previous 6 months for an asthma-related condition

• Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment

• Respiratory infection affecting the asthma within 30 days