Asthma Management Project University Leiden
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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:
- to investigate whether asthma management additionally guided by the degree of bronchial hyperresponsiveness leads to a better outcome
- 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 |
- Exacerbations
- Post-bronchodilator FEV1
- Bronchial hyperrsponsiveness
- Airway inflammationn in bronchial biopsies
| Estimated Enrollment: | 75 |
| Study Start Date: | May 1992 |
| Estimated Study Completion Date: | September 2008 |
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:
- 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.
- 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 |
Inclusion Criteria:
- Asthma based on GINA guidelines (www.ginasthma.org)
Exclusion Criteria:
- oral steroids
Contacts and Locations| Netherlands | |
| Leiden University Medical Center | |
| Leiden, Netherlands, NL-2300 RC | |
| 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 May 16, 2013