Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations - Tabular View

Tracking Information

First Received Date ^ICMJE

January 4, 2006

Last Updated Date

March 24, 2009

Start Date ^ICMJE

April 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The decrease in lung function (FEV1) after the third AMP provocation test.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00272753 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

Official Title ^ICMJE

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

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: budesonide/formoterol Turbuhaler
Drug: formoterol Turbuhaler
Drug: salbutamol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00272753

Responsible Party

Study ID Numbers ^ICMJE

BN-00S-0022

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca Netherlands Medical Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP