Symbicort Rapihaler Therapeutic Equivalence Study

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.

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

Details

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

Criteria

Inclusion Criteria:

• Asthma clinically diagnosed since at least 6 months.

• Lung function values measured ≥ 50% and ≤ 90% of predicted normal.

• Patients with reversible airway obstruction Daily use of inhaled steroids (any brand) for >3 months.

Exclusion Criteria:

• Use of oral, rectal or parenteral steroids within 30 days prior to start of study.

• Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to start of randomised treatment.

• Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.