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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00272753

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: budesonide/formoterol Turbuhaler Drug: formoterol Turbuhaler Drug: salbutamol	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Formoterol fumarate Levalbuterol hydrochloride Albuterol sulfate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome 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

Estimated Enrollment:	20
Study Start Date:	April 2004
Study Completion Date:	November 2005

Intervention Details:

Other Name: Symbicort

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272753

Locations

Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Groningen, Netherlands

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Netherlands Medical Director, MD

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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;11:66.

ClinicalTrials.gov Identifier:	NCT00272753 History of Changes
Other Study ID Numbers:	BN-00S-0022
Study First Received:	January 4, 2006
Last Updated:	May 31, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Formoterol
Budesonide
Symbicort
Tocolytic Agents
Reproductive Control Agents

Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids

ClinicalTrials.gov processed this record on February 12, 2012