NCT00279136

Brief Summary

Asthma and COPD are characterized by airway narrowing. The most potent, physiological mechanism leading to bronchodilation is taking a deep inspiration. This protects healthy subjects against bronchoconstrictive stimuli, and reverses pre-existing bronchoconstriction. However, the deep breath-induced bronchoprotection and -bronchodilation is impaired in asthma. We questioned whether this is specific for asthma (in comparison to COPD), and whether this is associated with bronchial inflammation and -remodelling. The study is a two-groups comparison, of physiological and pathological disease markers, obtained by methacholine challenges, monitoring airways resistance, and by taking bronchial biopsies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2004

Completed
1.4 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
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

January 19, 2006

Status Verified

September 1, 2005

First QC Date

January 17, 2006

Last Update Submit

January 17, 2006

Conditions

AsthmaChronic Obstructive Pulmonary Disease

Keywords

Bronchial hyperresponsiveness,lung function,airway inflammation,deep inspiration,bronchial biopsiesairway smooth muscle

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asthma according to GINA criteria (www.ginasthma.org)
  • COPD according to GOLD criteria (www.goldcopd.org)

You may not qualify if:

  • nonsmoking
  • inhaled or oral steroid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, NL-2300 RC, Netherlands

RECRUITING

Related Publications (1)

  • Slats AM, Janssen K, van Schadewijk A, van der Plas DT, Schot R, van den Aardweg JG, de Jongste JC, Hiemstra PS, Mauad T, Rabe KF, Sterk PJ. Bronchial inflammation and airway responses to deep inspiration in asthma and chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2007 Jul 15;176(2):121-8. doi: 10.1164/rccm.200612-1814OC. Epub 2007 Mar 22.

    PMID: 17379851DERIVED

Related Links

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic ObstructiveBronchial Hyperreactivity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter J. Sterk, MD, PhD

    Leiden University Medical Center

    STUDY CHAIR

Central Study Contacts

Peter J. Sterk, MD, PhD

CONTACT

+31 71 526 3578p.j.sterk@lumc.nl

Annelies M. Slats, MD

CONTACT

+31 71 526 3734a.m.slatts@lumc.nl

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2006

First Posted

January 19, 2006

Study Start

September 1, 2004

Study Completion

March 1, 2006

Last Updated

January 19, 2006

Record last verified: 2005-09

Locations

NL(1)