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...
Date First Received: January 4, 2006
Last Updated: March 17, 2008
Verified by: AstraZeneca, March 2008
Clinical Trial Phase: Phase 4 | Start Date: April 2004
Overall Status: Completed
Estimated Enrollment: 20
Brief Summary
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”
Condition Keyword(s):
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
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: budesonide/formoterol Turbuhaler
- Drug: formoterol Turbuhaler
- Drug: salbutamol
Outcome Measures for this Clinical Trial
Primary Measures
- The decrease in lung function (FEV1) after the third AMP provocation test.
Secondary Measures
- 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
AstraZeneca Netherlands Medical Director, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00272753
Study ID Number: BN-00S-0022
ClinicalTrials.gov Identifier: NCT00272753
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Clinical Trials Authorship and Review
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