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Inhaled Allergen Challenge Methodology: Assessment of a Vibrating Mesh Nebulizer for Allergen Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491358
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Don Cockcroft, University of Saskatchewan

Brief Summary:
This study will assess the Aerogen Solo® (Solo®) vibrating mesh nebulizer as a potential new device for use in allergen challenge testing.

Condition or disease Intervention/treatment Phase
Asthma Device: Wright jet nebulizer Device: Aerogen Solo Not Applicable

Detailed Description:

This will be a multi-center, randomized, cross-over study utilizing the expertise of three Canadian academic centers (University of Saskatchewan, McMaster University, Laval University) that have been performing allergen inhalation challenges and other bronchoprovocation studies for more than forty years.

Each participant will be required to attend the research lab on five occasions (Visits 1-5). At Visit 1, study staff will provide an overview of the study purpose and procedure and answer any questions the participant may have. The individual will then provide consent if they wish to participate (i.e. sign the consent form). Skin prick testing to determine relevant allergen sensitivities and to determine which allergen extract will be used for the skin test endpoint (STE) and allergen inhalation challenge will then be performed. The participant will be randomized with respect to which nebulizer (Solo® or Wright) will be used first. The choice of nebulizer for the first participant will be via blinded draw. Subsequent nebulizer assignments will alternate. Participants will undergo the STE procedure and methacholine challenge testing (MCT) at visit 2; an allergen challenge will be done the next day at Visit 3 using the same nebulizer as was used for the MCT at Visit 2. Visits 4 and 5 will also be performed on consecutive days and will involve methacholine and allergen challenge testing, respectively, using the nebulizer that was not used at Visits 2 and 3. A minimum of two weeks must separate Visits 3 and 4.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Inhaled Allergen Challenge Methodology: Assessment of a Vibrating Mesh Nebulizer for Allergen Administration
Actual Study Start Date : November 27, 2018
Actual Primary Completion Date : July 24, 2019
Actual Study Completion Date : July 24, 2019

Arm Intervention/treatment
Active Comparator: Wright jet nebulizer
Will employ the Wright jet nebulizer for use in an allergen challenge triad
Device: Wright jet nebulizer
Roxon Medi-Tech, Montreal, QC, Canada

Experimental: Solo vibrating mesh nebulizer
Will employ the Aerogen Solo vibrating mesh device for use in an allergen challenge triad
Device: Aerogen Solo
Aerogen Ltd., Galway, Ireland




Primary Outcome Measures :
  1. Allergen Solo EAR PD20 (provocative dose causing a 20% fall in forced expiratory volume, FEV1) [ Time Frame: Baseline ]
    Record the dose of allergen required to induce a 20% fall in forced expiratory volume using the Solo device


Secondary Outcome Measures :
  1. Predicted allergen Solo EAR PD20 [ Time Frame: Baseline (based on baseline methacholine challenge and skin test endpoint results) ]
    Will be predicted using the standard equation that employs the STE and MCT results



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • baseline FEV1 greater than or equal to 70%
  • positive response to inhaled methacholine (i.e. PD20 less than 400mcg)
  • evidence of atopy (i.e. positive skin prick test to an allergen that can be used for the inhalation challenge
  • absence of respiratory infection for at least 4 weeks
  • absence of allergen exposure (or other trigger of upper or lower respiratory symptoms) for at least 4 weeks
  • current nonsmoker (ex-smoker allowed; case by case basis; investigator discretion)
  • require only infrequent short-acting beta2 agonist (i.e. salbutamol or terbutaline) to treat/control asthma (i.e. no inhaled corticosteroid or combination therapies, no intranasal corticosteroid; anti-histamines etc.)
  • general good health with no other medical condition, medication use or lifestyle activities that would influence the outcome of the allergen challenge

Exclusion Criteria:

  • pregnant or lactating

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): NCT03491358


Locations
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Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Laval University
Québec City, Quebec, Canada, G1V 4G5
Canada, Saskatchewan
Asthma Research Lab - University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Dr. Don Cockcroft, MD University of Saskatchewan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Don Cockcroft, Professor, College of Medicine, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03491358    
Other Study ID Numbers: SOLO ALLERGEN 18
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Don Cockcroft, University of Saskatchewan:
vibrating mesh nebulizer
allergen challenge