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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
Information provided by:

Tracking Information
First Submitted Date  ICMJE January 4, 2006
First Posted Date  ICMJE January 9, 2006
Last Update Posted Date June 1, 2011
Study Start Date  ICMJE April 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2006)
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 Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: budesonide/formoterol Turbuhaler
    Other Name: Symbicort
  • Drug: formoterol Turbuhaler
  • Drug: salbutamol
Study Arms  ICMJE Not Provided
Publications * 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. doi: 10.1186/1465-9921-11-66.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 5, 2006)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Primary Completion Date Not Provided
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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00272753
Other Study ID Numbers  ICMJE BN-00S-0022
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca Netherlands Medical Director, MD AstraZeneca
PRS Account AstraZeneca
Verification Date May 2011

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