Trial record 6 of 9 for: AADCRC

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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:

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party):

Maria I. Garcia-Lloret, MD, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT01257191

First received: December 7, 2010

Last updated: January 9, 2017

Last verified: January 2017

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	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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Participant)
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 Maria I. Garcia-Lloret, MD, University of California, Los Angeles:

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 ]

Secondary Outcome Measures:

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 ]


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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:

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


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
Study First Received:	December 7, 2010
Last Updated:	January 9, 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

ClinicalTrials.gov processed this record on September 21, 2017

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