NCT00272753
Completed
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- AstraZeneca
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The decrease in lung function (FEV1) after the third AMP provocation test.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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
Investigators
Eligibility 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
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
Study Sites (1)
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