A Study to Compare the Effects of Different Sized Particles on Cells in the Nose
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ClinicalTrials.gov Identifier: NCT01257191 |
Recruitment Status
:
Completed
First Posted
: December 9, 2010
Last Update Posted
: January 11, 2017
|
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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 |
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 (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 |

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
|
- 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 ]
- Differential cell count in nasal lavages [ Time Frame: 6 and 24 hours post challenge ]
- IL-8 in nasal lavages [ Time Frame: 6 and 24 hours post challenge ]
- TNFα in nasal lavages [ Time Frame: 6 and 24 hours post challenge ]
- RANTES in nasal lavages [ Time Frame: 6 and 24 hours post challenge ]
- MCP-1 in nasal lavages [ Time Frame: 6 and 24 hours post challenge ]
- MIP-1α in nasal lavages [ Time Frame: 6 and 24 hours post challenge ]
- GM-CSF in nasal lavages [ Time Frame: 6 and 24 hours post challenge ]
- Nitrite in nasal lavages [ Time Frame: 6 and 24 hours post challenge ]
- Induced ROS generation (presence of intracellular thiol, 8-Isoprostane, and hydrogen peroxide) in nasal lavage cells [ Time Frame: 6 and 24 hours post challenge ]
- Phase II enzymes (HO-1, GSTP1, NQO1 and GSTM1) in nasal lavage [ Time Frame: 6 and 24 hours post challenge ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257191
United States, California | |
University of California, Los Angeles | |
Los Angeles, California, United States, 90095 |
Study Chair: | Maria G Lloret, MD | University of California, Los Angeles |
Additional Information:
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 Key Record Dates |
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 |