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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03491358
• Other study ID #: SOLO ALLERGEN 18
• Status: Completed
• Phase: N/A
• Start date: November 27, 2018
• Est. completion date: July 24, 2019

Study information

• Verified date: December 2019
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 24, 2019
• Est. primary completion date: July 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Wright jet nebulizer
Roxon Medi-Tech, Montreal, QC, Canada
• Aerogen Solo
Aerogen Ltd., Galway, Ireland

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	Laval University	Québec City	Quebec
Canada	Asthma Research Lab - University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allergen Solo EAR PD20 (provocative dose causing a 20% fall in forced expiratory volume, FEV1)	Record the dose of allergen required to induce a 20% fall in forced expiratory volume using the Solo device	Baseline
Secondary	Predicted allergen Solo EAR PD20	Will be predicted using the standard equation that employs the STE and MCT results	Baseline (based on baseline methacholine challenge and skin test endpoint results)