Status:

COMPLETED

Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

Lead Sponsor:

AstraZeneca

Conditions:

Asthma

Eligibility:

All Genders

18-55 years

Phase:

PHASE4

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 tes...

Eligibility Criteria

Inclusion

  • 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

  • having smoked \> 10 Pack-years,
  • hypersensitivity to one of the study drugs,
  • significant co-morbidity, pregnancy or lactating

Key Trial Info

Start Date :

April 1 2004

Trial Type :

INTERVENTIONAL

End Date :

November 1 2005

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT00272753

Start Date

April 1 2004

End Date

November 1 2005

Last Update

June 1 2011

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Research Site

Amsterdam, Netherlands

2

Research Site

Groningen, Netherlands