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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01257191
First received: December 7, 2010
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Hypersensitivity, Immediate
Atopic Hypersensitivity
 Drug: Carbon Black
Drug: Diesel Exhaust Particles
Drug: Fine Concentrated Ambient Particles
Drug: Ultrafine Concentrated Ambient Particles
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Cellular Inflammation Characterization of Nasal Challenges With Fine and Ultrafine Particles

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • The number of inflammatory cells in nasal lavage samples after exposure to 4 different types of particles [ Time Frame: 6 and 24 hours after nasal challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differential cell counts in nasal lavages [ Time Frame: 6 and 24 hours post challenge ] [ Designated as safety issue: No ]
  • IL-8 in nasal lavages [ Time Frame: 6 and 24 hours post challenge ] [ Designated as safety issue: No ]
  • TNFα in nasal lavages [ Time Frame: 6 and 24 hours post challenge ] [ Designated as safety issue: No ]
  • RANTES in nasal lavages [ Time Frame: 6 and 24 hours post challenge ] [ Designated as safety issue: No ]
  • MCP-1 in nasal lavages [ Time Frame: 6 and 24 hours post challenge ] [ Designated as safety issue: No ]
  • MIP-1α in nasal lavages [ Time Frame: 6 and 24 hours post challenge ] [ Designated as safety issue: No ]
  • GM-CSF in nasal lavages [ Time Frame: 6 and 24 hours post challenge ] [ Designated as safety issue: No ]
  • Nitrite levels in nasal lavages [ Time Frame: 6 and 24 hours post challenge ] [ Designated as safety issue: No ]
  • Induced ROS generation (intracellular thiol status, 8-Isoprostane levels, and hydrogen peroxide levels) in nasal lavage cells [ Time Frame: 6 and 24 hours post challenge ] [ Designated as safety issue: No ]
  • Phase II enzyme levels (HO-1, GSTP1, NQO1 and GSTM1) in nasal lavage [ Time Frame: 6 and 24 hours post challenge ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: April 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Saline
Saline solution

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257191

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Maria G Lloret, MD University of California, Los Angeles
  More Information

Additional Information:
National Institute of Allergy and Infectious Diseases (NIAID)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01257191     History of Changes
Other Study ID Numbers: DAIT AADCRC-UCLA-02
Study First Received: December 7, 2010
Last Updated: October 9, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vehicle Emissions
Diesel Exhaust

Additional relevant MeSH terms:
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013