Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

Phase 4

Completed

• Conditions: Asthma

• Registration Number: NCT00272753
• Lead Sponsor: AstraZeneca

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study Completion: 2005-11
• Study First Submitted: 2006-01-04
• Study First Submitted QC: 2006-01-05
• Study First Posted: 2006-01-09
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The decrease in lung function (FEV1) after the third AMP provocation test.

Secondary Outcome Measures

Name	Time	Method
lung function and Borg Score over the test day,
increase in FEV1 at three minutes after study drug inhalation,
time course of recovery from the AMP-induced decrease in lung function
Decrease in lung function (FEV1) after the second AMP provocation test,

Trial Locations

Locations (1)

Research Site; 🇳🇱 Groningen, Netherlands