Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

NCT ID: NCT00272753

Last Updated: 2011-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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budesonide/formoterol Turbuhaler

Intervention Type DRUG

formoterol Turbuhaler

Intervention Type DRUG

salbutamol

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Netherlands Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Amsterdam, , Netherlands

Site Status

Research Site

Groningen, , Netherlands

Site Status

Countries

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Netherlands

References

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Aalbers R, Boorsma M, van der Woude HJ, Jonkers RE. Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study. Respir Res. 2010 May 28;11(1):66. doi: 10.1186/1465-9921-11-66.

Reference Type DERIVED
PMID: 20509942 (View on PubMed)

Other Identifiers

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BN-00S-0022

Identifier Type: -

Identifier Source: org_study_id

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