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Asthma Management Project University Leiden

This study has been completed.
Sponsor:
Collaborator:
The Netherlands Asthma Foundation
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00279188
First received: January 17, 2006
Last updated: NA
Last verified: September 2004
History: No changes posted

January 17, 2006
January 17, 2006
May 1992
Not Provided
  • Exacerbations
  • Post-bronchodilator FEV1
Same as current
No Changes Posted
  • Bronchial hyperrsponsiveness
  • Airway inflammationn in bronchial biopsies
Same as current
Not Provided
Not Provided
 
Asthma Management Project University Leiden
Asthma Management Project University Leiden

The long-term course of asthma shows variable outcome with regard to the incidence of exacerbations and the decline of lung function over time. The present study aimed:

  1. to investigate whether asthma management additionally guided by the degree of bronchial hyperresponsiveness leads to a better outcome
  2. to examine the predictors among clinical and inflammatory disease markers of the long-term decline in lung function

Asthma is associated with a specific inflamma¬tory state of the airways. Assuming that the degree of airway inflammation is a determinant for the long-term disease outcome, it follows that, asthma therapy should be aimed at maximal reduction of airway inflammation, in addition to reducing symptoms. However, according to current guidelines, therapy should only be directed to the clinical severity of the disease. There is increasing evidence that bronchial hyper¬respon¬siveness can be used as a non-invasive reflection of airway inflamma¬tion [29]. However, it is still unknown whether bronchial responsiveness provides relevant additional information for adjusting therapy during follow-up of patients with asthma. Therefore, in this study we will:

  1. compare the disease outcome in two parallel groups of patients with asthma, receiving therapy aimed at either clinical severity only, or therapy aimed at both clinical severity, and bronchial hyper¬responsiveness to methacho¬li¬ne. The outcome will be assessed at three levels. First, the severity, second, lung function and bronchial responsive¬ness, and third, humoral, cellular, and histological indices of airway inflamma¬tion. To that end we will assess symptoms, lung function, bronchial respon¬siveness, and immunological parameters in blood, every three months. Furthermore, a bronchos¬copy with a bronchoalveolar lavage and bronchial biopsy will be carried out to provide for material for immunologic and pathologic anatomical examination, at the beginning and at the end of the study.
  2. analyse the predictors among clinical- and inflammatory parameters of exacerbations and long-term decline in lung function during long-term follow-up
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Asthma
Procedure: Guiding therapy by bronchial hyperrsponsiveness
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
September 2008
Not Provided

Inclusion Criteria:

  • Asthma based on GINA guidelines (www.ginasthma.org)

Exclusion Criteria:

  • oral steroids
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00279188
AF 3.2.92.45, AMPUL, AF 3.2.92.45
Not Provided
Not Provided
Leiden University Medical Center
The Netherlands Asthma Foundation
Study Chair: Peter J. Sterk, MD, PhD Leiden University Medical Center
Leiden University Medical Center
September 2004

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