Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

A Randomized Double Blind Comparison Between Single Doses of Symbicort Turbuhaler (Budesonide/Formoterol Combination), Formoterol, Salbutamol and Placebo in Repeated AMP-challenges in Patients With Mild - to Moderate Asthma. Investigating the Supplementary Value of the Budesonide Component Within Symbicort When Tested in a Model of Slow Onset Acute Asthma

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00272753

Enrollment

Registered

2006-01-09

Start date

2004-04-30

Completion date

2005-11-30

Last updated

2011-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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

Interventions

DRUGbudesonide/formoterol Turbuhaler

DRUGformoterol Turbuhaler

DRUGsalbutamol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
The decrease in lung function (FEV1) after the third AMP provocation test.	—

Secondary

Measure	Time frame
time course of recovery from the AMP-induced decrease in lung function	—
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,	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026