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

• Sponsor: University of Saskatchewan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03491358
• Collaborator: (none)
• Enrollment: 18
• Locations: 3
• Arms: 2
• Actual Duration (Months): 7.9
• Patients Per Site: 6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• 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: Nov 27, 2018
• Actual Primary Completion Date: Jul 24, 2019
• Actual Study Completion Date: Jul 24, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Allergen Solo EAR PD20 (provocative dose causing a 20% fall in forced expiratory volume, FEV1) [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McMaster University	Hamilton	Ontario	Canada	L8N 3Z5
2	Laval University	Québec City	Quebec	Canada	G1V 4G5
3	Asthma Research Lab - University of Saskatchewan	Saskatoon	Saskatchewan	Canada	S7N 0W8

Sponsors and Collaborators

• University of Saskatchewan

Investigators

• Principal Investigator: Dr. Don Cockcroft, MD, University of Saskatchewan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Don Cockcroft, Professor, College of Medicine, University of Saskatchewan
• ClinicalTrials.gov Identifier: NCT03491358
• Other Study ID Numbers: SOLO ALLERGEN 18
• First Posted: Apr 9, 2018
• Last Update Posted: Dec 10, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Don Cockcroft, Professor, College of Medicine, University of Saskatchewan: vibrating mesh nebulizer; allergen challenge

Study Results

No Results Posted as of Dec 10, 2019