A Study to Compare the Effects of Different Sized Particles on Cells in the Nose

Cellular Inflammation Characterization of Nasal Challenges With Fine and Ultrafine Particles

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.

Study Overview

• Status: Completed
• Conditions: Hypersensitivity, Immediate; Atopic Hypersensitivity
• Intervention / Treatment: Drug: Carbon Black; Drug: Diesel Exhaust Particles; Drug: Fine Concentrated Ambient Particles; Drug: Ultrafine Concentrated Ambient Particles; Drug: Saline

Detailed Description

Cough, bronchitis, asthma, and chronic obstructive pulmonary disease are all associated with elevated pollution particle levels. Researchers believe that particulate pollutants can exacerbate allergy and inflammation and affect asthma and allergy prevalence. In an urban setting such as the Los Angeles Basin, particles generated by vehicular traffic are thought to be important risk factors. Recently, the Environmental Health Centre of Southern California confirmed that there is a strong association between traffic near homes and schools and development of asthma. This study will help researchers describe the effects of various size pollution particles in causing inflammation in the nose.

There will be a total of 20 study visits. The study procedures include physical exams, symptom score for nose, nose washes and nose challenges with particulate matter. The particulates will be given in a random order and include the following: saline (sterile salt water), inert carbon particles (Carbon Black), diesel exhaust particles (DEP), small (fine) particles or very small (ultrafine) particles. These last two (fine and ultrafine) particles are obtained from concentrated normal Los Angeles air. The particulate will be sprayed into the nose with a standard nasal spray.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Saline; Saline solution
Experimental: Carbon Black	Drug: Carbon Black; source: commercial
Experimental: Diesel Exhaust Particles	Drug: Diesel Exhaust Particles; source: diesel engine
Experimental: Fine Concentrated Ambient Particles	Drug: Fine Concentrated Ambient Particles; source: concentrated ambient air
Experimental: Ultrafine Concentrated Ambient Particles	Drug: Ultrafine Concentrated Ambient Particles; source: concentrated ambient air

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
MIP-1α in nasal lavages	6 and 24 hours post challenge
GM-CSF in nasal lavages	6 and 24 hours post challenge
Nitrite in nasal lavages	6 and 24 hours post challenge
Induced ROS generation (presence of intracellular thiol, 8-Isoprostane, and hydrogen peroxide) in nasal lavage cells	6 and 24 hours post challenge
Phase II enzymes (HO-1, GSTP1, NQO1 and GSTM1) in nasal lavage	6 and 24 hours post challenge

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Maria G Lloret, MD, University of California, Los Angeles

Publications and helpful links

Helpful Links

• National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: December 7, 2010
• First Submitted That Met QC Criteria: December 7, 2010
• First Posted (Estimate): December 9, 2010

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Vehicle Emissions; Diesel Exhaust
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Hypersensitivity, Immediate
• Other Study ID Numbers: DAIT AADCRC-UCLA-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No