Asthma Management Project University Leiden

Asthma Clinical Trial

Official title:

Asthma Management Project University Leiden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279188
• Other study ID #: AF 3.2.92.45, AMPUL
• Secondary ID: AF 3.2.92.45
• Status: Completed
• Phase: N/A
• First received: January 17, 2006
• Last updated: January 17, 2006
• Start date: May 1992
• Est. completion date: September 2008

Study information

• Verified date: September 2004
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• oral steroids

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Procedure:
• Guiding therapy by bronchial hyperrsponsiveness

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	The Netherlands Asthma Foundation

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Sont JK, Willems LN, Bel EH, van Krieken JH, Vandenbroucke JP, Sterk PJ. Clinical control and histopathologic outcome of asthma when using airway hyperresponsiveness as an additional guide to long-term treatment. The AMPUL Study Group. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1043-51. — View Citation

van Rensen EL, Sont JK, Evertse CE, Willems LN, Mauad T, Hiemstra PS, Sterk PJ; AMPUL Study Group. Bronchial CD8 cell infiltrate and lung function decline in asthma. Am J Respir Crit Care Med. 2005 Oct 1;172(7):837-41. Epub 2005 Aug 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exacerbations
Primary	Post-bronchodilator FEV1
Secondary	Bronchial hyperrsponsiveness
Secondary	Airway inflammationn in bronchial biopsies

External Links

•   Leiden University Medical Center