Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations
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...
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”
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
AstraZeneca Netherlands Medical Director, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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)
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00272753
