Asthma Management Project University Leiden | NCT00279188

Studies
Asthma Management Project University Leiden

NCT00279188

Sponsor

Leiden University Medical Center

Status

Completed

Last Update Posted

Jan 19, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Asthma

Interventions

Guiding therapy by bronchial hyperrsponsiveness

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
AF 3.2.92.45

Status Module

Record Verification Date

Sep 2004

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1992

Primary Completion Date

Not provided

Completion Date

Sep 2008

First Submitted Date

Jan 17, 2006

First Submission Date that Met QC Criteria

Jan 17, 2006

First Posted Date

Jan 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2006

Last Update Posted Date

Jan 19, 2006Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Leiden University Medical CenterOTHER

Collaborators

Name	Class
The Netherlands Asthma Foundation	OTHER

Description Module

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:

to investigate whether asthma management additionally guided by the degree of bronchial hyperresponsiveness leads to a better outcome
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:

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Guiding therapy by bronchial hyperrsponsiveness	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exacerbations
Post-bronchodilator FEV1

Secondary Outcomes

Measure	Description	Time Frame
Bronchial hyperrsponsiveness
Airway inflammationn in bronchial biopsies

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

oral steroids

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter J. Sterk, MD, PhD	Leiden University Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leiden University Medical Center		Leiden		NL-2300 RC	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16085937	Background	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.
10194144	Background	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.

ID	Term
D001249	Asthma
D016535	Bronchial Hyperreactivity

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases