Asthma Management Project University Leiden

Not Applicable

Completed

• Conditions: Asthma

• Registration Number: NCT00279188
• Lead Sponsor: 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

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 Timeline

• Study Start: 1992-05
• Status Verified: 2004-09
• Study First Submitted: 2006-01-17
• Study First Submitted QC: 2006-01-17
• Last Update Submitted: 2006-01-17
• Study First Posted: 2006-01-19
• Last Update Posted: 2006-01-19
• Study Completion: 2008-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

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

Exclusion Criteria

• oral steroids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Exacerbations
Post-bronchodilator FEV1

Secondary Outcome Measures

Name	Time	Method
Bronchial hyperrsponsiveness
Airway inflammationn in bronchial biopsies

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands