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Asthma Management Project University Leiden

Asthma Management Project University Leiden

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00279188
Enrollment
75
Registered
2006-01-19
Start date
1992-05-31
Completion date
2008-09-30
Last updated
2006-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Bronchial hyperresponsiveness, Atopy, Inhaled steroids, Exacerbations, Lung function decline, Prognosis

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

Interventions

PROCEDUREGuiding therapy by bronchial hyperrsponsiveness

Sponsors

The Netherlands Asthma Foundation
CollaboratorOTHER
Leiden University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* oral steroids

Design outcomes

Primary

MeasureTime frame
Exacerbations
Post-bronchodilator FEV1

Secondary

MeasureTime frame
Bronchial hyperrsponsiveness
Airway inflammationn in bronchial biopsies

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026