Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

AstraZeneca20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

budesonide/formoterol TurbuhalerDRUG

formoterol TurbuhalerDRUG

salbutamolDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Amsterdam, Netherlands

Research Site

Groningen, Netherlands

Outcomes

Primary Outcomes

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

Secondary Outcomes

Decrease in lung function (FEV1) after the second AMP provocation test,

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

Data from ClinicalTrials.gov

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