Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics

Launched by ORION CORPORATION, ORION PHARMA · Aug 24, 2009

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males or females aged 18-60 years with documented diagnosis of asthma
• • Prebronchodilator forced expiratory volume in one second (FEV1) at least 80% of the predicted value
• • The asthma should be stable on the same regular treatment for at least 4 weeks before screening.
• Exclusion Criteria:
• • Use of oral, parenteral or rectal corticosteroids within 4 weeks preceding the screening
• • Respiratory infection within 4 weeks preceding the screening
• • Any condition requiring regular concomitant treatment or likely to need concomitant treatment during the study with medicinal products which have pharmacokinetic interactions with budesonide
• • Any disorder or clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study