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The Phthalate-Allergen Immune Response Study (PAIR)

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ClinicalTrials.gov Identifier: NCT02688478
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher Carlsten, University of British Columbia

Brief Summary:
Phthalates are commonly used plasticizers that have been linked to asthma in epidemiological studies. The investigators are researching effects of phthalates on airway immunology and lung function, and on allergic responses by doing an inhaled allergen challenge. After exposing participants to either filtered air or carefully controlled levels of phthalate in our exposure chamber we will collect samples from the nose and the upper airways, by rinsing the nose with saltwater or performing small brushings. The investigators will also collect a bronchial samples by bronchoscopy after each exposure. After 2 weeks, the entire procedure will be repeated with the alternate exposure.

Condition or disease Intervention/treatment Phase
Allergies Other: Phthalate Other: Filtered Air Other: Allergen Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Phthalate Inhalation on Airway Immunology: A Controlled Human Exposure Study
Actual Study Start Date : February 2, 2017
Estimated Primary Completion Date : May 7, 2019
Estimated Study Completion Date : May 7, 2020

Arm Intervention/treatment
Active Comparator: Filtered air
Exposure for 3 hours to filtered air followed by subject specific inhaled allergen challenge
Other: Filtered Air
Delivered by inhalation on day 1 of the triad

Other: Allergen
Subject specific allergen is delivered by inhalation on day 1 of the triad

Experimental: Phthalate
Exposure for 3 hours to dibutyl phthalate followed by subject specific inhaled allergen challenge
Other: Phthalate
Delivered by inhalation on day 1 of the triad
Other Name: DBP

Other: Allergen
Subject specific allergen is delivered by inhalation on day 1 of the triad




Primary Outcome Measures :
  1. Recruitment of immune cells in airways [ Time Frame: 3-24 hours ]
    Recruitment will be identified by performing differential cell counts

  2. Activation of immune cells in airways [ Time Frame: 3-24 hours ]
    Cellular activation will be measured by cytokine expression in bronchoalveolar lavage.

  3. Airway responsiveness [ Time Frame: 3-24 hours ]
    Airway responsiveness will be measured by methacholine challenge.

  4. Airway Inflammation [ Time Frame: 3-24 hours ]
    Airway Inflammation will be measured by Fractional exhaled NO.


Secondary Outcome Measures :
  1. Allergen specific IgE [ Time Frame: 24 hours ]
    Allergen specific IgE will be measured in airway and blood samples.

  2. Inflammatory markers in plasma and cell function after in vitro stimulation with inflammatory ligands (LPS & R848) [ Time Frame: 3-24h ]
    whole blood In vitro stimulation using inflammatory ligands will be analyzed for inflammatory markers, same as in plasma.

  3. Response of immune cells in blood [ Time Frame: 3-24 hours ]
    Immune cell responses will be identified by analyzing changes in cellular activation

  4. Response of immune cells in airways [ Time Frame: 3-24 hours ]
    Cellular activation will be measured after in-vitro stimulation with inflammatory ligands like Lipopolysaccharide.

  5. Lung responsiveness [ Time Frame: 3-24 hours ]
    Airway responsiveness will be measured by spirometry.



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Ages Eligible for Study:   19 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age between 19 and 49 years.
  2. Non-smoking.
  3. Proficient in English
  4. Positive skin prick test for at least one of: birch, grass, or dust.
  5. Healthy, or diagnosed with mild asthma

Exclusion Criteria

  1. pregnancy/breastfeeding
  2. unstable asthma symptoms (eg: exacerbations in previous 2 weeks)
  3. use of inhaled corticosteroids or bronchodilator medication more than 3 times a week
  4. presence of co-existing medical conditions i.e. arrythmia (as assessed by the primary investigator)
  5. participation in another study that involves taking medications
  6. regular use of antihistamines, non-steroidal anti-inflammatories, anticoagulants, acetylsalicylic acid (ASA) or decongestants
  7. allergy to salbutamol or lidocaine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688478


Contacts
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Contact: Christopher Carlsten, MD, MPH 604-875-4122 carlsten@mail.ubc.ca

Locations
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Canada, British Columbia
University of British columbia Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Christopher Carlsten, MD, PHD    604-875-4122    carlsten@mail.ubc.ca   
Principal Investigator: Christopher Carlsten, MD, MPH         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Christopher Carlsten, MD, MPH University of British Columbia

Publications:
Peters,S., Shaver,J., & Zangrilli,J.G. Airway responses to antigen in asthmatic and nonasthmatic subjects in Inflammatory mechanisms in asthma (eds. Holgate,S.T. & Busse,W.W.) (Marcel Dekker, New York, 2014).

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Responsible Party: Christopher Carlsten, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02688478     History of Changes
Other Study ID Numbers: H14-01119
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christopher Carlsten, University of British Columbia:
Phthalate
Dibutylphthalate (DBP)
Airway responsiveness
Allergies