Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT04630405
Status:
UNKNOWN
Last Update Posted:
2020-11-16
First Post:
2020-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of SOLO Vibrating Mesh Nebulizer for Allergen-Induced Late Asthmatic Responses
Sponsor:
McMaster University
Organization:
Study Overview
Official Title:
Inhaled Allergen Challenge Methodology: Assessment of SOLO Vibrating Mesh Nebulizer for Allergen-Induced Late Asthmatic Responses
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOLO-LAR
Brief Summary:
This is a mechanistic study. Having established safety with the Solo® nebulizer and the ability to predict allergen PD20 using the methacholine PD20 and STE, the current study will assess the use of the Solo® vibrating mesh nebulizer on development of allergen-induced endpoints during the late phase response.
Detailed Description:
Ten asthmatic subjects (\>18 years, both sexes) who have stable asthma will be recruited to undergo inhaled allergen and diluent challenges for a randomized, 2-way crossover study. The primary objective is to compare the development of LAR between allergen (known to cause EAR and LAR) and diluent control challenges (does not cause EAR and LAR) using the Solo® vibrating mesh nebulizer using a standardized inhaled allergen challenge. Subject will undergo an allergen challenge with the Solo® compared to two different controls; diluent inhalation (a negative control with saline inhalation that does not cause LAR), and versus allergen challenge with control Wright nebulizer (positive control using a nebulizer that is known to cause LAR). Up to 2 academic centres will participate in this study. The results of this study will examine if the Solo® vibrating mesh nebulizer is an adequate substitution for the Wright nebulizer.
Screening
Skin Prick test and Skin Prick test endpoint
Randomization
The washout time after each allergen/diluent challenge triad will be 3-5 weeks.
Wright Nebulizer Allergen Inhalation triad will be conducted over 3 consecutive days.
On day 1: Wright® MCT to determine methacholine PC20 for 1) eligibility, and 2) to calculate the predicted Wright® allergen PC20. If the participant meets eligibility criterion, they will undergo blood draw, sputum induction and breath analysis to measure baseline airway inflammation. Day 2: Wright® allergen challenge will be performed. Participants that demonstrate early asthmatic response (≥20% drop in FEV1 during the period10 min-2h post-allergen) and the late asthmatic response (≥15% drop in FEV1 during the period 3-7h post-allergen challenge) will be eligible to continue in the study. If the participant meets eligibility criterion, they will undergo blood draw, sputum induction and breath analysis to measure airway inflammation at 7h post-challenge. Day 3:Wright® MCT to determine the degree of allergen-induced airway hyperresponsiveness, and they will undergo blood draw, sputum induction and breath analysis to measure airway inflammation at 24h post-challenge.
The order of the Solo® nebulizer allergen and diluent challenges will be conducted in a random order during the second and third triads. These challenge triads will be conducted over 3 consecutive days. Day 1: Solo® MCT to determine methacholine PD20 to calculate the predicted Solo® allergen PD20, followed by sputum induction to measure baseline airway inflammation. Day 2: Solo® allergen challenge or diluent challenge will be performed. Sputum induction will be conducted to measure airway inflammation at 7h post-challenge. Day 3: Solo® MCT to determine the degree of airway hyperresponsiveness at 24h post-allergen and post-diluent challenge, followed by sputum induction to measure airway inflammation at 24h post-challenge.
Screening
Skin Prick test and Skin Prick test endpoint
Randomization
The washout time after each allergen/diluent challenge triad will be 3-5 weeks.
Wright Nebulizer Allergen Inhalation triad will be conducted over 3 consecutive days.
On day 1: Wright® MCT to determine methacholine PC20 for 1) eligibility, and 2) to calculate the predicted Wright® allergen PC20. If the participant meets eligibility criterion, they will undergo blood draw, sputum induction and breath analysis to measure baseline airway inflammation. Day 2: Wright® allergen challenge will be performed. Participants that demonstrate early asthmatic response (≥20% drop in FEV1 during the period10 min-2h post-allergen) and the late asthmatic response (≥15% drop in FEV1 during the period 3-7h post-allergen challenge) will be eligible to continue in the study. If the participant meets eligibility criterion, they will undergo blood draw, sputum induction and breath analysis to measure airway inflammation at 7h post-challenge. Day 3:Wright® MCT to determine the degree of allergen-induced airway hyperresponsiveness, and they will undergo blood draw, sputum induction and breath analysis to measure airway inflammation at 24h post-challenge.
The order of the Solo® nebulizer allergen and diluent challenges will be conducted in a random order during the second and third triads. These challenge triads will be conducted over 3 consecutive days. Day 1: Solo® MCT to determine methacholine PD20 to calculate the predicted Solo® allergen PD20, followed by sputum induction to measure baseline airway inflammation. Day 2: Solo® allergen challenge or diluent challenge will be performed. Sputum induction will be conducted to measure airway inflammation at 7h post-challenge. Day 3: Solo® MCT to determine the degree of airway hyperresponsiveness at 24h post-allergen and post-diluent challenge, followed by sputum induction to measure airway inflammation at 24h post-challenge.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: