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Completed

NCT Number: NCT01257191

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbon Black

Drug

source: commercial

Diesel Exhaust Particles

Drug

source: diesel engine

Fine Concentrated Ambient Particles

Drug

source: concentrated ambient air

Ultrafine Concentrated Ambient Particles

Drug

source: concentrated ambient air

Saline

Drug

Saline solution

Primary outcomes

  1. 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

Secondary outcomes

  1. Differential cell count in nasal lavages

    Time frame: 6 and 24 hours post challenge

  2. IL-8 in nasal lavages

    Time frame: 6 and 24 hours post challenge

  3. TNFα in nasal lavages

    Time frame: 6 and 24 hours post challenge

  4. RANTES in nasal lavages

    Time frame: 6 and 24 hours post challenge

  5. MCP-1 in nasal lavages

    Time frame: 6 and 24 hours post challenge

  6. MIP-1α in nasal lavages

    Time frame: 6 and 24 hours post challenge

  7. GM-CSF in nasal lavages

    Time frame: 6 and 24 hours post challenge

  8. Nitrite in nasal lavages

    Time frame: 6 and 24 hours post challenge

  9. Induced ROS generation (presence of intracellular thiol, 8-Isoprostane, and hydrogen peroxide) in nasal lavage cells

    Time frame: 6 and 24 hours post challenge

  10. Phase II enzymes (HO-1, GSTP1, NQO1 and GSTM1) in nasal lavage

    Time frame: 6 and 24 hours post challenge

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Cellular Inflammation Characterization of Nasal Challenges With Fine and Ultrafine Particles

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 9, 2010
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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