Asthma Management Project University Leiden

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: NCT00279188
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : January 19, 2006
The Netherlands Asthma Foundation
Information provided by:
Leiden University Medical Center

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Asthma Procedure: Guiding therapy by bronchial hyperrsponsiveness Not Applicable

Detailed Description:

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Asthma Management Project University Leiden
Study Start Date : May 1992
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. Exacerbations
  2. Post-bronchodilator FEV1

Secondary Outcome Measures :
  1. Bronchial hyperrsponsiveness
  2. Airway inflammationn in bronchial biopsies

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Asthma based on GINA guidelines (

Exclusion Criteria:

  • oral steroids

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): NCT00279188

Leiden University Medical Center
Leiden, Netherlands, NL-2300 RC
Sponsors and Collaborators
Leiden University Medical Center
The Netherlands Asthma Foundation
Study Chair: Peter J. Sterk, MD, PhD Leiden University Medical Center

Additional Information:
Publications: Identifier: NCT00279188     History of Changes
Other Study ID Numbers: AF, AMPUL
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: January 19, 2006
Last Verified: September 2004

Keywords provided by Leiden University Medical Center:
Bronchial hyperresponsiveness
Inhaled steroids
Lung function decline

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases