Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: salbutamol; Drug: budesonide/formoterol Turbuhaler; Drug: formoterol Turbuhaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT00272753

BN-00S-0022

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind