Hypersensitivity, ImmediatePhase 1NCT01257191
A Study to Compare the Effects of Different Sized Particles on Cells in the Nose
A Phase 1 study testing Carbon Black, Diesel Exhaust Particles and Fine Concentrated Ambient Particles in people with Hypersensitivity, Immediate and Atopic Hypersensitivity, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersensitivity, Immediate, Atopic Hypersensitivity
- What is being tested?
- Carbon Black, Diesel Exhaust Particles and Fine Concentrated Ambient Particles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously determined high inflammatory responders to Diesel Exhaust Particles
- Previously determined atopy as demonstrated by allergy skin testing
- Asymptomatic on day of challenge.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Cellular Inflammation Characterization of Nasal Challenges With Fine and Ultrafine Particles
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.
Read the 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.
- Being tested
- Carbon Black, Diesel Exhaust Particles, Fine Concentrated Ambient Particles, Ultrafine Concentrated Ambient Particles, Saline
- Keywords
- Vehicle Emissions, Diesel Exhaust
- Medical subject headings
- Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon BlackDrug
source: commercial
Diesel Exhaust ParticlesDrug
source: diesel engine
Fine Concentrated Ambient ParticlesDrug
source: concentrated ambient air
Ultrafine Concentrated Ambient ParticlesDrug
source: concentrated ambient air
SalineDrug
Saline solution
| Study group | Role | What they receive |
|---|---|---|
| Carbon Black | Experimental | Not described Receives: Drug: Carbon Black |
| Diesel Exhaust Particles | Experimental | Not described Receives: Drug: Diesel Exhaust Particles |
| Fine Concentrated Ambient Particles | Experimental | Not described Receives: Drug: Fine Concentrated Ambient Particles |
| Ultrafine Concentrated Ambient Particles | Experimental | Not described Receives: Drug: Ultrafine Concentrated Ambient Particles |
| Placebo | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of inflammatory cells in nasal lavage samples after exposure to 4 different types of particles
Measured: 6 and 24 hours after nasal challenge
Secondary outcomes (10)
Differential cell count in nasal lavages
Measured: 6 and 24 hours post challenge
IL-8 in nasal lavages
Measured: 6 and 24 hours post challenge
TNFα in nasal lavages
Measured: 6 and 24 hours post challenge
RANTES in nasal lavages
Measured: 6 and 24 hours post challenge
MCP-1 in nasal lavages
Measured: 6 and 24 hours post challenge
MIP-1α in nasal lavages
Measured: 6 and 24 hours post challenge
GM-CSF in nasal lavages
Measured: 6 and 24 hours post challenge
Nitrite in nasal lavages
Measured: 6 and 24 hours post challenge
Induced ROS generation (presence of intracellular thiol, 8-Isoprostane, and hydrogen peroxide) in nasal lavage cells
Measured: 6 and 24 hours post challenge
Phase II enzymes (HO-1, GSTP1, NQO1 and GSTM1) in nasal lavage
Measured: 6 and 24 hours post challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersensitivity, ImmediateStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria I. Garcia-Lloret, MD, University of California, Los Angeles
- Investigators
- Maria G Lloret, MD, Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257191
- Sponsor's protocol ID
- DAIT AADCRC-UCLA-02
- Status last verified
- Jan 2017
- First submitted
- 7 Dec 2010
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Inflammation Characterization of Nasal Challenges With Fine and Ultrafine Particles
- ClinicalTrials.gov ID
- NCT01257191
- Acronym / sponsor ID
- DAIT AADCRC-UCLA-02
- Keywords
- Vehicle Emissions, Diesel Exhaust
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Apr 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Carbon Black | Experimental | Drug: Carbon Black |
| Diesel Exhaust Particles | Experimental | Drug: Diesel Exhaust Particles |
| Fine Concentrated Ambient Particles | Experimental | Drug: Fine Concentrated Ambient Particles |
| Ultrafine Concentrated Ambient Particles | Experimental | Drug: Ultrafine Concentrated Ambient Particles |
| Placebo | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previously determined high inflammatory responders to Diesel Exhaust Particles
- Previously determined atopy as demonstrated by allergy skin testing
- Asymptomatic on day of challenge.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon Blacksource: commercial | Drug | Carbon Black |
| Diesel Exhaust Particlessource: diesel engine | Drug | Diesel Exhaust Particles |
| Fine Concentrated Ambient Particlessource: concentrated ambient air | Drug | Fine Concentrated Ambient Particles |
| Ultrafine Concentrated Ambient Particlessource: concentrated ambient air | Drug | Ultrafine Concentrated Ambient Particles |
| SalineSaline solution | Drug | Placebo |
Primary outcome
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
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria G Lloret, MD study chair
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carbon Black, Diesel Exhaust Particles and Fine Concentrated Ambient Particles in people with Hypersensitivity, Immediate and Atopic Hypersensitivity, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.