NCT00279188

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. 1.to investigate whether asthma management additionally guided by the degree of bronchial hyperresponsiveness leads to a better outcome
  2. 2.to examine the predictors among clinical and inflammatory disease markers of the long-term decline in lung function

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started May 1992

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1992

Completed
13.7 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

January 19, 2006

Status Verified

September 1, 2004

First QC Date

January 17, 2006

Last Update Submit

January 17, 2006

Conditions

Asthma

Keywords

Bronchial hyperresponsivenessAtopyInhaled steroidsExacerbationsLung function declinePrognosis

Outcome Measures

Primary Outcomes (2)

  • Exacerbations

  • Post-bronchodilator FEV1

Secondary Outcomes (2)

  • Bronchial hyperrsponsiveness

  • Airway inflammationn in bronchial biopsies

Interventions

Guiding therapy by bronchial hyperrsponsivenessPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • oral steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, NL-2300 RC, Netherlands

Location

Related Publications (2)

  • 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. doi: 10.1164/rccm.200504-619OC. Epub 2005 Aug 4.

    PMID: 16085937BACKGROUND

  • 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. doi: 10.1164/ajrccm.159.4.9806052.

    PMID: 10194144BACKGROUND

Related Links

MeSH Terms

Conditions

AsthmaBronchial Hyperreactivity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Peter J. Sterk, MD, PhD

    Leiden University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2006

First Posted

January 19, 2006

Study Start

May 1, 1992

Study Completion

September 1, 2008

Last Updated

January 19, 2006

Record last verified: 2004-09

Locations

NL(1)