Asthma Management Project University Leiden

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Asthma Management Project University Leiden

Conditions
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Asthma

Intervention / Treatment
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* Procedure: Guiding therapy by bronchial hyperrsponsiveness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asthma based on GINA guidelines (www.ginasthma.org) Exclusion Criteria: oral steroids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Guiding therapy by bronchial hyperrsponsiveness|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbations |  |  | 
| Post-bronchodilator FEV1 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchial hyperrsponsiveness |  |  | 
| Airway inflammationn in bronchial biopsies |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchial hyperresponsiveness, Atopy, Inhaled steroids, Exacerbations, Lung function decline, Prognosis