NCT00217854

Brief Summary

The purpose of this study is to examine inflammatory processes in the airway of moderate to severe persistent asthmatics who have persistent bronchial hyperreactivity despite chronic administration of inhaled glucocorticoids.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Sep 2001

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

September 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

7.4 years

First QC Date

September 19, 2005

Last Update Submit

June 23, 2017

Conditions

Asthma

Keywords

asthma, corticosteroids

Outcome Measures

Primary Outcomes (1)

  • change in CD3 positive T cells in the airway submucosa

    Measured at Week 4

Secondary Outcomes (5)

  • inflammatory cell markers in the airway (CD4, CD8, CD68, CD45, EG2/MBP, tryptase, and neutrophil elastase)

    Measured at Week 4

  • RANTES expression in airway

    Measured at Week 4

  • FEV1, peak expiratory flows

    Measured at Week 4

  • methacholine PC20

    Measured at Week 4

  • asthma symptom score

    Measured at Week 4

Study Arms (1)

Open label inhaled fluticasone

OTHER

Patients are treated with open label high dose fluticasone for 30 days then discontinued. Comparisons are pre- and post- treatment single arm.

Procedure: Bronchoscopic

Interventions

BronchoscopicPROCEDURE

Bronchoscopic procedure

Open label inhaled fluticasone

Eligibility Criteria

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

You may qualify if:

  • Symptoms of asthma as defined by the American Thoracic Society (ATS) definition. This includes the following:
  • history of episodic shortness of breath (with or without associated wheezing) in association with reversible obstructive airways disease with at least a 20% decrement in FEV1 and FVC (from predicted values) that is documented at some time point by pulmonary function tests
  • an improvement in expiratory flow rates of at least 15% of predicted values after inhalation of a beta-2 selective bronchodilator medication or other previous treatment (e.g. corticosteroids)
  • The diagnosis may also be confirmed by an abnormal bronchospastic response to methacholine or exercise as described by Cherniak
  • FEV1 greater than or equal to 70% of predicted value at time of study entry
  • Regular use of inhaled corticosteroids at time of study entry (at least 400 mcg of Beclomethasone or equivalent)

You may not qualify if:

  • Used inhaled cromolyn (Intal) or nedocromil (Tilade) in the month prior to study entry
  • History of severe asthma requiring intubation
  • Any cardiopulmonary or neurologic abnormality with which the risk of performing the procedure would outweigh the potential benefits (other than asthma)
  • Upper respiratory tract infection or clinical evidence of a sinus infection during the month preceding the test
  • History of cigarette smoking within the 5 years prior to study entry or greater than 10 pack-years total
  • Pregnant or refuses to undergo urine pregnancy testing if female of child-bearing age (women of childbearing potential will not be challenged \[methacholine challenge\] unless they have had a menstrual period in the last 10 days or a negative pregnancy test within 2 weeks or are practicing adequate contraception)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Castro M, Bloch SR, Jenkerson MV, DeMartino S, Hamilos DL, Cochran RB, Zhang XE, Wang H, Bradley JP, Schechtman KB, Holtzman MJ. Asthma exacerbations after glucocorticoid withdrawal reflects T cell recruitment to the airway. Am J Respir Crit Care Med. 2004 Apr 1;169(7):842-9. doi: 10.1164/rccm.200208-960OC. Epub 2004 Jan 15.

    PMID: 14726420BACKGROUND

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mario Castro

    Washington University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Pediatrics

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

September 1, 2001

Primary Completion

February 1, 2009

Study Completion

February 1, 2011

Last Updated

June 26, 2017

Record last verified: 2017-06

Locations

US(1)