Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: budesonide/formoterol Turbuhaler (Drug); formoterol Turbuhaler (Drug); salbutamol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Netherlands Medical Director, MD, Study Director, Affiliation: AstraZeneca
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
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: The decrease in lung function (FEV1) after the third AMP provocation test.
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Research Site, Groningen, Netherlands
Research Site, Amsterdam, Netherlands
Additional Information
AstraZeneca Clinical Trial Information - Outside US
Starting date: April 2004
Last updated: March 17, 2008
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