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

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
Groningen, Netherlands
Research Site
Amsterdam, Netherlands

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Netherlands Medical Director, MD

AstraZeneca

More Information

Additional Information:

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	BN-00S-0022
Study First Received:	January 4, 2006
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00272753 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Symbicort
Bronchial Diseases
Albuterol
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive

Respiratory Tract Diseases
Tocolytic Agents
Therapeutic Uses
Formoterol
Immune System Diseases
Adrenergic beta-Agonists
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009