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OpenTrials
Completed

NCT Number: NCT00279188

Asthma Management Project University Leiden

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

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center

Leiden, NL-2300 RC, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • oral steroids

Treatment and study plan

Guiding therapy by bronchial hyperrsponsiveness

Procedure

Primary outcomes

  1. Exacerbations

  2. Post-bronchodilator FEV1

Secondary outcomes

  1. Bronchial hyperrsponsiveness

  2. Airway inflammationn in bronchial biopsies

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • The Netherlands Asthma Foundation

Registry information

Important dates

Study start
1992
Study completion
2008
First posted
Jan 19, 2006
Registry last updated
Jan 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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