AllergiesNCT01792232
Effects of Co-Exposure to Air Pollution and Allergen
A study testing Allergen and Saline in people with Allergies, run by University of British Columbia at 1 site in Canada.
Trial summary
The investigators are investigating the effects of combined exposures to diesel exhaust and allergens on lung function and on the immune system. After exposing individuals to either filtered air or carefully controlled levels of diesel exhaust in our exposure chamber, The investigators will use a procedure called… Read more about this study
- Who is it for?
- Ages 19 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergies
- What is being tested?
- Allergen and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Nov 2013
- Phase
- Interventional
- 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 19 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 19 and 49 years.
- Non-smoking.
- Positive skin prick test for at least one of: birch, grass, or dust
Who cannot join
- Using inhaled corticosteroids
- Pregnant or planning to be pregnant in the next 12 months / Breastfeeding
- Usage of bronchodilators more than three times per week.
- Co-morbidities (as assessed by the primary investigator)
- Taking part in other studies
- Unwilling to withhold bronchodilator, aspirin, anti-coagulant, antihistamine or decongestant medications or caffeine prior to testing procedures.
Show all 9Show fewer
- FEV1(Forced expiratory volume in one second) < 70% predicted.
- Allergy to lidocaine, fentanyl, midazolam or salbutamol.
- Unstable asthma (i.e exacerbation in 2 weeks preceding testing)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Effect of Exposure to Allergens and Air Pollution on Lung Function and Immunity
The investigators are investigating the effects of combined exposures to diesel exhaust and allergens on lung function and on the immune system. After exposing individuals to either filtered air or carefully controlled levels of diesel exhaust in our exposure chamber, The investigators will use a procedure called bronchoscopy (whereby a thin, flexible tube is passed down the throat and into the lungs) to place a small amount of allergen directly in the lung. 48h later, the bronchoscopy will be repeated so that samples can be collected from the lungs. After 1mo, the entire procedure will be repeated with the alternate exposure.
Read the detailed description
- Purpose/Objective: To study the effects of diesel exhaust particles on lung function and on allergic responses.
- Hypotheses: Hypothesis 1: DE exposure augments systemic oxidative stress from allergen challenge in allergen-sensitized individuals. Hypothesis 2: DE exposure augments allergen-specific immune response in allergen-challenged airways in sensitized individuals. These responses will be greater in asthmatic individuals than in non-asthmatics.
- Justification: The use of diesel engines is increasing because they are more fuel-efficient than gasoline engines. However, diesel engines produce different emissions than gasoline engines. Diesel exhaust is emitted from the tailpipe of both "on-road" diesel engine vehicles (diesel cars, buses and trucks) and "non-road" diesel engines (locomotives, marine vessels and some construction equipment). Diesel exhaust consists of both gaseous and particulate air pollutants. Since people with asthma and allergic diseases appear to be sensitive to air pollution, we would like to know how diesel exhaust (DE) can affects your respiratory and immune systems. We are expecting that any responses that may occur will only be detectable through careful examination of cells and tissues (e.g., bronchoalveolar lavage (fluid from your lungs), blood, urine). Understanding these potentially subtle changes will help us prevent health problems associated with air pollution in the future.
- Research Method:
This is a blinded crossover experiment between two conditions (DE or filtered air, FA), randomized and counter-balanced to order. Data collection for each condition will be separated by a 4-week washout period.
Following each exposure, The investigators will use bronchoscopy (performed at the Vancouver General Hospital Endoscopy Suite) to deliver a diluent-controlled segmental allergen challenge (SAC). 24 h post-SAC, airway reactivity will be assessed with a methacholine challenge. 48 h post-SAC, bronchoalveolar lavage (BAL), airway brushes and tissue biopsies will be obtained in the same regions for analysis of immune activation. Nasal lavage samples will also be collected to examine responses in the upper airways and blood and urine will be studied to examine systemic responses. Spirometry and methacholine challenge will be used to assess effects on airway function
- Conditions
- Allergies
- Being tested
- Allergen, Saline
- Keywords
- Diesel exhaust, Air pollution, Airway responsiveness, Allergies
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllergenOther
Subject specific allergen is placed in the lungs on day 1 of each triad
SalineOther
Saline will be placed in the lung on day 1 of each triad
| Study group | Role | What they receive |
|---|---|---|
| Filtered air | Active comparator | Exposure for 2 hours to filtered air followed by subject specific allergen placed in lung Receives: Other: Allergen |
| Diesel exhaust | Experimental | Exposure for 2 hours to diesel exhaust followed by subject specific allergen placed in lung Receives: Other: Allergen |
| Filtered air control | Active comparator | Exposure for 2 hours to filtered air followed by subject saline placed in lung Receives: Other: Saline |
| Diesel exhaust control | Active comparator | Exposure for 2 hours to diesel exhaust followed by saline placed in lung Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergen-specific IgE
BAL IgE specific to the allergen used for allergen challenge will be assessed at 48 hrs, from the BAL, using immunocap assay
Measured: 48 hours
Secondary outcomes (3)
Human immune response
Determine if allergen-induced eosinophilic activation (measured by flow cytometry) and a Th2-type cytokine pattern is augmented by DE (300 µg/m3 inhaled for two hours) exposure.
Measured: 48 hours
Oxidative stress
Establish that bronchial segment allergen-induced oxidative stress (urine 8-isoprostane, measured by ELISA) is augmented by DE (300 µg/m3 inhaled for two hours) exposure.
Measured: 48 hours
Airway reactivity
Determine if airway reactivity (measured by PC20 methacholine challenge) is augmented by DE (300 µg/m3 inhaled for two hours) exposure.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startOct 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AllergiesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Carlsten, University of British Columbia
- Investigators
- Christopher Carlsten, MD, MPH, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792232
- Sponsor's protocol ID
- H11-01831
- Status last verified
- Sep 2017
- First submitted
- 14 Nov 2012
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Saxon A, Diaz-Sanchez D. Air pollution and allergy: you are what you breathe. Nat Immunol. 2005 Mar;6(3):223-6. doi: 10.1038/ni0305-223. No abstract available.
PubMed 15716966Rudell B, Ledin MC, Hammarstrom U, Stjernberg N, Lundback B, Sandstrom T. Effects on symptoms and lung function in humans experimentally exposed to diesel exhaust. Occup Environ Med. 1996 Oct;53(10):658-62. doi: 10.1136/oem.53.10.658.
PubMed 8943829Diaz-Sanchez D, Tsien A, Fleming J, Saxon A. Combined diesel exhaust particulate and ragweed allergen challenge markedly enhances human in vivo nasal ragweed-specific IgE and skews cytokine production to a T helper cell 2-type pattern. J Immunol. 1997 Mar 1;158(5):2406-13.
PubMed 9036991Fujieda S, Diaz-Sanchez D, Saxon A. Combined nasal challenge with diesel exhaust particles and allergen induces In vivo IgE isotype switching. Am J Respir Cell Mol Biol. 1998 Sep;19(3):507-12. doi: 10.1165/ajrcmb.19.3.3143.
PubMed 9730879Hashimoto K, Ishii Y, Uchida Y, Kimura T, Masuyama K, Morishima Y, Hirano K, Nomura A, Sakamoto T, Takano H, Sagai M, Sekizawa K. Exposure to diesel exhaust exacerbates allergen-induced airway responses in guinea pigs. Am J Respir Crit Care Med. 2001 Nov 15;164(10 Pt 1):1957-63. doi: 10.1164/ajrccm.164.10.2011070.
PubMed 11734452Carlsten, C., et al., Symptoms and perceptions in response to a controlled diesel exhaust exposure in healthy adults. Environmental Research, In Review
Riedl MA, Diaz-Sanchez D, Linn WS, Gong H Jr, Clark KW, Effros RM, Miller JW, Cocker DR, Berhane KT; HEI Health Review Committee. Allergic inflammation in the human lower respiratory tract affected by exposure to diesel exhaust. Res Rep Health Eff Inst. 2012 Feb;(165):5-43; discussion 45-64.
PubMed 22852485Carlsten C, Melen E. Air pollution, genetics, and allergy: an update. Curr Opin Allergy Clin Immunol. 2012 Oct;12(5):455-60. doi: 10.1097/ACI.0b013e328357cc55.
PubMed 22885891Kramer MM, Hirota JA, Sood A, Teschke K, Carlsten C. Airway and serum adipokines after allergen and diesel exposure in a controlled human crossover study of atopic adults. Transl Res. 2017 Apr;182:49-60. doi: 10.1016/j.trsl.2016.11.001. Epub 2016 Nov 9.
PubMed 27886976Hosseini A, Hirota JA, Hackett TL, McNagny KM, Wilson SJ, Carlsten C. Morphometric analysis of inflammation in bronchial biopsies following exposure to inhaled diesel exhaust and allergen challenge in atopic subjects. Part Fibre Toxicol. 2016 Jan 13;13:2. doi: 10.1186/s12989-016-0114-z.
PubMed 26758251Carlsten C, Blomberg A, Pui M, Sandstrom T, Wong SW, Alexis N, Hirota J. Diesel exhaust augments allergen-induced lower airway inflammation in allergic individuals: a controlled human exposure study. Thorax. 2016 Jan;71(1):35-44. doi: 10.1136/thoraxjnl-2015-207399. Epub 2015 Nov 16.
PubMed 26574583
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exposure to Allergens and Air Pollution on Lung Function and Immunity
- ClinicalTrials.gov ID
- NCT01792232
- Acronym / sponsor ID
- H11-01831
- Conditions
- Allergies
- Keywords
- Diesel exhaust, Air pollution, Airway responsiveness, Allergies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 15 Feb 2013 (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 investigators are investigating the effects of combined exposures to diesel exhaust and allergens on lung function and on the immune system. After exposing individuals to either filtered air or carefully controlled levels of diesel exhaust in our exposure chamber, The investigators will use a procedure called bronchoscopy (whereby a thin, flexible tube is passed down the throat and into the lungs) to place a small amount of allergen directly in the lung. 48h later, the bronchoscopy will be repeated so that samples can be collected from the lungs. After 1mo, the entire procedure will be repeated with the alternate exposure.
Detailed description
- Purpose/Objective: To study the effects of diesel exhaust particles on lung function and on allergic responses.
- Hypotheses: Hypothesis 1: DE exposure augments systemic oxidative stress from allergen challenge in allergen-sensitized individuals. Hypothesis 2: DE exposure augments allergen-specific immune response in allergen-challenged airways in sensitized individuals. These responses will be greater in asthmatic individuals than in non-asthmatics.
- Justification: The use of diesel engines is increasing because they are more fuel-efficient than gasoline engines. However, diesel engines produce different emissions than gasoline engines. Diesel exhaust is emitted from the tailpipe of both "on-road" diesel engine vehicles (diesel cars, buses and trucks) and "non-road" diesel engines (locomotives, marine vessels and some construction equipment). Diesel exhaust consists of both gaseous and particulate air pollutants. Since people with asthma and allergic diseases appear to be sensitive to air pollution, we would like to know how diesel exhaust (DE) can affects your respiratory and immune systems. We are expecting that any responses that may occur will only be detectable through careful examination of cells and tissues (e.g., bronchoalveolar lavage (fluid from your lungs), blood, urine). Understanding these potentially subtle changes will help us prevent health problems associated with air pollution in the future.
- Research Method:
This is a blinded crossover experiment between two conditions (DE or filtered air, FA), randomized and counter-balanced to order. Data collection for each condition will be separated by a 4-week washout period.
Following each exposure, The investigators will use bronchoscopy (performed at the Vancouver General Hospital Endoscopy Suite) to deliver a diluent-controlled segmental allergen challenge (SAC). 24 h post-SAC, airway reactivity will be assessed with a methacholine challenge. 48 h post-SAC, bronchoalveolar lavage (BAL), airway brushes and tissue biopsies will be obtained in the same regions for analysis of immune activation. Nasal lavage samples will also be collected to examine responses in the upper airways and blood and urine will be studied to examine systemic responses. Spirometry and methacholine challenge will be used to assess effects on airway function
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Filtered air | Active comparator | Other: AllergenExposure for 2 hours to filtered air followed by subject specific allergen placed in lung |
| Diesel exhaust | Experimental | Other: AllergenExposure for 2 hours to diesel exhaust followed by subject specific allergen placed in lung |
| Filtered air control | Active comparator | Other: SalineExposure for 2 hours to filtered air followed by subject saline placed in lung |
| Diesel exhaust control | Active comparator | Other: SalineExposure for 2 hours to diesel exhaust followed by saline placed in lung |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 19 and 49 years.
- Non-smoking.
- Positive skin prick test for at least one of: birch, grass, or dust
Key exclusion criteria (9 listed)
- Using inhaled corticosteroids
- Pregnant or planning to be pregnant in the next 12 months / Breastfeeding
- Usage of bronchodilators more than three times per week.
- Co-morbidities (as assessed by the primary investigator)
- Taking part in other studies
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 |
|---|---|---|
| AllergenSubject specific allergen is placed in the lungs on day 1 of each triad | Other | Diesel exhaust, Filtered air |
| SalineSaline will be placed in the lung on day 1 of each triad | Other | Diesel exhaust control, Filtered air control |
Primary outcome
Allergen-specific IgE
Time frame: 48 hours
BAL IgE specific to the allergen used for allergen challenge will be assessed at 48 hrs, from the BAL, using immunocap assay
3 secondary outcomes
Human immune response
Time frame: 48 hours
Oxidative stress
Time frame: 48 hours
Airway reactivity
Time frame: 48 hours
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 29 Sep 2017.
- Background: PubMed 15716966Saxon A, Diaz-Sanchez D. Air pollution and allergy: you are what you breathe. Nat Immunol. 2005 Mar;6(3):223-6. doi: 10.1038/ni0305-223. No abstract available.
- Background: PubMed 8943829Rudell B, Ledin MC, Hammarstrom U, Stjernberg N, Lundback B, Sandstrom T. Effects on symptoms and lung function in humans experimentally exposed to diesel exhaust. Occup Environ Med. 1996 Oct;53(10):658-62. doi: 10.1136/oem.53.10.658.
- Background: PubMed 9036991Diaz-Sanchez D, Tsien A, Fleming J, Saxon A. Combined diesel exhaust particulate and ragweed allergen challenge markedly enhances human in vivo nasal ragweed-specific IgE and skews cytokine production to a T helper cell 2-type pattern. J Immunol. 1997 Mar 1;158(5):2406-13.
- Background: PubMed 9730879Fujieda S, Diaz-Sanchez D, Saxon A. Combined nasal challenge with diesel exhaust particles and allergen induces In vivo IgE isotype switching. Am J Respir Cell Mol Biol. 1998 Sep;19(3):507-12. doi: 10.1165/ajrcmb.19.3.3143.
- Background: PubMed 11734452Hashimoto K, Ishii Y, Uchida Y, Kimura T, Masuyama K, Morishima Y, Hirano K, Nomura A, Sakamoto T, Takano H, Sagai M, Sekizawa K. Exposure to diesel exhaust exacerbates allergen-induced airway responses in guinea pigs. Am J Respir Crit Care Med. 2001 Nov 15;164(10 Pt 1):1957-63. doi: 10.1164/ajrccm.164.10.2011070.
- BackgroundCarlsten, C., et al., Symptoms and perceptions in response to a controlled diesel exhaust exposure in healthy adults. Environmental Research, In Review
- Background: PubMed 22852485Riedl MA, Diaz-Sanchez D, Linn WS, Gong H Jr, Clark KW, Effros RM, Miller JW, Cocker DR, Berhane KT; HEI Health Review Committee. Allergic inflammation in the human lower respiratory tract affected by exposure to diesel exhaust. Res Rep Health Eff Inst. 2012 Feb;(165):5-43; discussion 45-64.
- Background: PubMed 22885891Carlsten C, Melen E. Air pollution, genetics, and allergy: an update. Curr Opin Allergy Clin Immunol. 2012 Oct;12(5):455-60. doi: 10.1097/ACI.0b013e328357cc55.
- Derived from this study: PubMed 27886976Kramer MM, Hirota JA, Sood A, Teschke K, Carlsten C. Airway and serum adipokines after allergen and diesel exposure in a controlled human crossover study of atopic adults. Transl Res. 2017 Apr;182:49-60. doi: 10.1016/j.trsl.2016.11.001. Epub 2016 Nov 9.
- Derived from this study: PubMed 26758251Hosseini A, Hirota JA, Hackett TL, McNagny KM, Wilson SJ, Carlsten C. Morphometric analysis of inflammation in bronchial biopsies following exposure to inhaled diesel exhaust and allergen challenge in atopic subjects. Part Fibre Toxicol. 2016 Jan 13;13:2. doi: 10.1186/s12989-016-0114-z.
- Derived from this study: PubMed 26574583Carlsten C, Blomberg A, Pui M, Sandstrom T, Wong SW, Alexis N, Hirota J. Diesel exhaust augments allergen-induced lower airway inflammation in allergic individuals: a controlled human exposure study. Thorax. 2016 Jan;71(1):35-44. doi: 10.1136/thoraxjnl-2015-207399. Epub 2015 Nov 16.
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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.
Christopher Carlsten, MD, MPH principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allergen and Saline in people with Allergies, run by University of British Columbia at 1 site in Canada.
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 9 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 29 Sep 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Allergen-specific IgE (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01792232, which also lists 11 linked publications.
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 29 Sep 2017.