NCT01257191

Brief Summary

The goal of this study is to see how the type and size of particles found in air pollution affects inflammation in the nose in people who are skin test positive to at least one allergen. It has been observed that pollution makes allergies worse. It has also been suggested that very small particles may affect allergies more than larger particles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2010

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

April 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

December 7, 2010

Last Update Submit

January 9, 2017

Conditions

Hypersensitivity, ImmediateAtopic Hypersensitivity

Keywords

Vehicle EmissionsDiesel Exhaust

Outcome Measures

Primary Outcomes (1)

  • The number of inflammatory cells in nasal lavage samples after exposure to 4 different types of particles

    6 and 24 hours after nasal challenge

Secondary Outcomes (10)

  • Differential cell count in nasal lavages

    6 and 24 hours post challenge

  • IL-8 in nasal lavages

    6 and 24 hours post challenge

  • TNFα in nasal lavages

    6 and 24 hours post challenge

  • RANTES in nasal lavages

    6 and 24 hours post challenge

  • MCP-1 in nasal lavages

    6 and 24 hours post challenge

  • +5 more secondary outcomes

Study Arms (5)

Carbon Black

EXPERIMENTAL
Drug: Carbon Black

Diesel Exhaust Particles

EXPERIMENTAL
Drug: Diesel Exhaust Particles

Fine Concentrated Ambient Particles

EXPERIMENTAL
Drug: Fine Concentrated Ambient Particles

Ultrafine Concentrated Ambient Particles

EXPERIMENTAL
Drug: Ultrafine Concentrated Ambient Particles

Placebo

PLACEBO COMPARATOR
Drug: Saline

Interventions

Carbon BlackDRUG

source: commercial

Carbon Black
Diesel Exhaust ParticlesDRUG

source: diesel engine

Diesel Exhaust Particles
Fine Concentrated Ambient ParticlesDRUG

source: concentrated ambient air

Fine Concentrated Ambient Particles
Ultrafine Concentrated Ambient ParticlesDRUG

source: concentrated ambient air

Ultrafine Concentrated Ambient Particles
SalineDRUG

Saline solution

Placebo

Eligibility Criteria

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

You may qualify if:

  • Previously determined high inflammatory responders to Diesel Exhaust Particles
  • Previously determined atopy as demonstrated by allergy skin testing
  • Asymptomatic on day of challenge.

You may not qualify if:

  • History of lung problems (including asthma), bleeding, neuromuscular, liver, kidney or heart disorders.
  • History of anaphylaxis.
  • Recent upper respiratory infection (less than 4 weeks prior to study) or other active infection.
  • Active smoker or smoker in the past 2 years.
  • Treatment with topical nasal steroids (\< 1 month), systemic steroids (\<1 month), oral antihistamines (\< 1 week) prior to any nasal challenge.
  • Use of leukotriene receptor antagonist (\< 1 month ) prior to any nasal challenge
  • Intranasal antihistamine or cromolyn use \< 1 week prior to any nasal challenge .
  • History of treatment with allergy immunotherapy.
  • Inability to perform nasal lavage.
  • Inability to give written informed consent
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Links

MeSH Terms

Conditions

Hypersensitivity, Immediate

Interventions

SootSodium Chloride

Condition Hierarchy (Ancestors)

HypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

SmokeParticulate MatterComplex MixturesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Maria G Lloret, MD

    University of California, Los Angeles

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2010

First Posted

December 9, 2010

Study Start

April 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

US(1)