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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hypersensitivity, Immediate; Atopic Hypersensitivity	Drug: Carbon Black; Drug: Diesel Exhaust Particles; Drug: Fine Concentrated Ambient Particles; Drug: Ultrafine Concentrated Ambient Particles; Drug: Saline	Phase 1

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Participant)
Official Title:	Cellular Inflammation Characterization of Nasal Challenges With Fine and Ultrafine Particles
Study Start Date :	April 2010
Actual Primary Completion Date :	January 2012
Actual Study Completion Date :	January 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University of California, Los Angeles

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	Maria G Lloret, MD	University of California, Los Angeles

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

National Institute of Allergy and Infectious Diseases (NIAID) 

Responsible Party:	Maria I. Garcia-Lloret, MD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT01257191 History of Changes
Other Study ID Numbers:	DAIT AADCRC-UCLA-02
First Posted:	December 9, 2010
Last Update Posted:	January 11, 2017
Last Verified:	January 2017

Keywords provided by Maria I. Garcia-Lloret, MD, University of California, Los Angeles:

Vehicle Emissions; Diesel Exhaust

Additional relevant MeSH terms:

Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases