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
  Purpose

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 Intervention
Asthma
Procedure: Guiding therapy by bronchial hyperrsponsiveness

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Asthma Management Project University Leiden

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Exacerbations
  • Post-bronchodilator FEV1

Secondary Outcome Measures:
  • Bronchial hyperrsponsiveness
  • Airway inflammationn in bronchial biopsies

Estimated Enrollment: 75
Study Start Date: May 1992
Estimated Study Completion Date: September 2008
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
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • oral steroids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279188

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00279188     History of Changes
Other Study ID Numbers: AF 3.2.92.45, AMPUL, AF 3.2.92.45
Study First Received: January 17, 2006
Last Updated: January 17, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on April 14, 2014