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

NCT ID: NCT01257191

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-01-31

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.

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.

Conditions

Hypersensitivity, Immediate; Atopic Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

Carbon Black

Group Type: EXPERIMENTAL

Carbon Black

Intervention Type: DRUG

source: commercial

Diesel Exhaust Particles

Group Type: EXPERIMENTAL

Diesel Exhaust Particles

Intervention Type: DRUG

source: diesel engine

Fine Concentrated Ambient Particles

Group Type: EXPERIMENTAL

Fine Concentrated Ambient Particles

Intervention Type: DRUG

source: concentrated ambient air

Ultrafine Concentrated Ambient Particles

Group Type: EXPERIMENTAL

Ultrafine Concentrated Ambient Particles

Intervention Type: DRUG

source: concentrated ambient air

Placebo

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Saline solution

Interventions

Carbon Black

source: commercial

Intervention Type: DRUG

Diesel Exhaust Particles

source: diesel engine

Intervention Type: DRUG

Fine Concentrated Ambient Particles

source: concentrated ambient air

Intervention Type: DRUG

Ultrafine Concentrated Ambient Particles

source: concentrated ambient air

Intervention Type: DRUG

Saline

Saline solution

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Maria I. Garcia-Lloret, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria G Lloret, MD

Role: STUDY_CHAIR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Countries

United States

Related Links

http://www.niaid.nih.gov

National Institute of Allergy and Infectious Diseases (NIAID)

Other Identifiers

DAIT AADCRC-UCLA-02

Identifier Type: -

Identifier Source: org_study_id