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Trial record 97 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00272753
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : June 1, 2011
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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

Condition or disease Intervention/treatment Phase
Asthma Drug: budesonide/formoterol Turbuhaler Drug: formoterol Turbuhaler Drug: salbutamol Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : April 2004
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Intervention Details:
  • Drug: budesonide/formoterol Turbuhaler
    Other Name: Symbicort
  • Drug: formoterol Turbuhaler
  • Drug: salbutamol

Primary Outcome Measures :
  1. The decrease in lung function (FEV1) after the third AMP provocation test.

Secondary Outcome Measures :
  1. Decrease in lung function (FEV1) after the second AMP provocation test,
  2. lung function and Borg Score over the test day,
  3. increase in FEV1 at three minutes after study drug inhalation,
  4. time course of recovery from the AMP-induced decrease in lung function

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00272753

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Research Site
Amsterdam, Netherlands
Research Site
Groningen, Netherlands
Sponsors and Collaborators
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Study Director: AstraZeneca Netherlands Medical Director, MD AstraZeneca

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00272753     History of Changes
Other Study ID Numbers: BN-00S-0022
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
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Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents