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

Hypersensitivity, Immediate Clinical Trial

Official title:

Cellular Inflammation Characterization of Nasal Challenges With Fine and Ultrafine Particles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257191
• Other study ID #: DAIT AADCRC-UCLA-02
• Status: Completed
• Phase: Phase 1
• First received: December 7, 2010
• Last updated: January 9, 2017
• Start date: April 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2017
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Atopic Hypersensitivity
• Hypersensitivity
• Hypersensitivity, Immediate

Intervention

Drug:
• Carbon Black
source: commercial
• Diesel Exhaust Particles
source: diesel engine
• Fine Concentrated Ambient Particles
source: concentrated ambient air
• Ultrafine Concentrated Ambient Particles
source: concentrated ambient air
• Saline
Saline solution

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of inflammatory cells in nasal lavage samples after exposure to 4 different types of particles		6 and 24 hours after nasal challenge	No
Secondary	Differential cell count in nasal lavages		6 and 24 hours post challenge	No
Secondary	IL-8 in nasal lavages		6 and 24 hours post challenge	No
Secondary	TNFa in nasal lavages		6 and 24 hours post challenge	No
Secondary	RANTES in nasal lavages		6 and 24 hours post challenge	No
Secondary	MCP-1 in nasal lavages		6 and 24 hours post challenge	No
Secondary	MIP-1a in nasal lavages		6 and 24 hours post challenge	No
Secondary	GM-CSF in nasal lavages		6 and 24 hours post challenge	No
Secondary	Nitrite in nasal lavages		6 and 24 hours post challenge	No
Secondary	Induced ROS generation (presence of intracellular thiol, 8-Isoprostane, and hydrogen peroxide) in nasal lavage cells		6 and 24 hours post challenge	No
Secondary	Phase II enzymes (HO-1, GSTP1, NQO1 and GSTM1) in nasal lavage		6 and 24 hours post challenge	No

External Links

•   National Institute of Allergy and Infectious Diseases (NIAID)