NCT00671593

Brief Summary

The purpose of this study is to identify the genes in important airway cells that are specifically expressed following inhalation of house dust mite allergen among study subjects with either allergic asthma or healthy normal phenotypes. This approach is designed to identify novel genes associated with both asthma pathogenesis (differentially expressed in the exposure-response study) and asthma susceptibility (genetically associated with asthma in a linkage/association study) for drug targets.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

July 16, 2013

Status Verified

July 1, 2013

Enrollment Period

1.5 years

First QC Date

May 2, 2008

Last Update Submit

July 15, 2013

Conditions

Atopic AsthmaHealthy

Keywords

AllergyAsthmahealthyNormal

Outcome Measures

Primary Outcomes (1)

  • Identify genes in airway epithelial and BAL cells that are differentially expressed following inhalation of house dust mite allergen among study subjects with allergic asthma and normal phenotypes.

    24 hours post challenge

Study Arms (1)

Experimental inhaled dust mite

EXPERIMENTAL

All subjects receive the same experimental inhaled challenge interventions

Biological: House Dust MiteBiological: Diluent

Interventions

House Dust MiteBIOLOGICAL

Dermatophagoides pteronyssinus: nebulized inhaled dosing is every 10 minutes per protocol limits at the following Allergen Concentration , (5 breaths of duration 0.8 seconds using a dosimeter) 0.0 AU, 0.3 AU/ml, 1 AU/ml, 3 AU/ml, 10 AU/ml, 30 AU/ml, 100 AU/ml, 300 AU/ml, 1000 AU/ml, 3000 AU/ml

Also known as: Allergen Extract Stand. Mite Dermatophagoides pteronyssinus
Experimental inhaled dust mite
DiluentBIOLOGICAL

Greer lab allergen extract diluent (0.5% sodium chloride, 0.25% sodium bicarbonate, 50% glycerin (v/v), and 0.4% phenol)nebulized inhaled dosing is every 10 minutes per protocol limits at the following Diluent Concentration, (5 breaths of duration 0.8 seconds using a dosimeter)

Also known as: diluent(0.5% Nacl,0.25% NaHCO3,50% glycerin,& 0.4% phenol)
Experimental inhaled dust mite

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Allergic asthmatic, or nonallergic nonasthmatic
  • Willing/able to give informed consent \& adhere to visit/protocol schedules.
  • Screening visit laboratory, C-Xray, EKG, results within normal limits
  • Women of childbearing potential must have a negative serum pregnancy test
  • Screening Pulmonary function testing above study criteria parameters

You may not qualify if:

  • Systemic corticosteroid administration for asthma within the previous 90days
  • Antibiotic administration within the previous 30 days.
  • Viral respiratory infection within the previous 14 days.
  • Allergen immunotherapy to House dust mite within the last 10 years
  • History of severe asthma requiring intubation.
  • Occupational exposure to hay or grain dust.
  • Significant exposure history to cigarette smoke
  • Past or present history of allergen immunotherapy to within the last 10 yrs
  • Underlying illnesses that may result in altered lung function
  • Students or employees under direct supervision by protocol investigators are ineligible
  • Subjects allergic to medications used (or potentially used) in the study will be excluded.
  • Subjects using aspirin will be excluded
  • Subjects who abuse alcohol or illicit substances will be excluded
  • Medication use other than for asthma, allergies or contraception
  • Other medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

HypersensitivityAsthma

Interventions

Antigens, DermatophagoidesPhenol

Condition Hierarchy (Ancestors)

Immune System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

AntigensBiological FactorsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • John S Sundy, M.D., PhD.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

May 2, 2008

First Posted

May 5, 2008

Study Start

October 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2009

Last Updated

July 16, 2013

Record last verified: 2013-07

Locations

US(1)