Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim is to study whether the budesonide component within the budesonide/ formoterol combination inhaler has additive value in a model of "slow onset acute asthma" , namely three AMP provocation tests performed on one day

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• asthma diagnosis according to ATS criteria,

• lung function (FEV1) above 60% of predicted,

• AMP-PC20 below 160 mg/ml with a documented fall in FEV1 of 30% in this provocation test

Exclusion Criteria:

• having smoked > 10 Pack-years,

• hypersensitivity to one of the study drugs,

• significant co-morbidity, pregnancy or lactating