Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411886
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-03-11
Brief Title:
Measurements of Inflammation Induced by Allergen Inhalation Challenge in Mild Allergic Asthma
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Optimizing the Measurement of Therapeutic Targets for Treatment of Asthma Induced by Allergen Inhalation Challenge in Mild Allergic Asthma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
MATT
Brief Summary:
This study will measure lung function tests and examine biological samples collected before and after inhaled allergen challenges and diluent control challenges in participants with mild allergic asthma
Detailed Description:
This study will measure lung function tests examine biological samples collected before and after inhaled allergen challenges and diluent control challenges in participants with mild allergic asthma Each inhaled challenge will consist of 3 consecutive days triads where participants will inhale either allergen extract or saline diluent control and airway function will be measured and biological samples will be obtained Inhaled allergen challenges will be controlled with diluent inhalation challenge in a randomized crossover design Each participant will be required to attend the research lab on at least three consecutive days for an inhaled challenge triad On triad Day 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 informed consent if they wish to participate ie sign the consent form and safety labs will be collected for blood chemistry and hematology urinalysis Skin prick testing will be conducted to determine relevant allergen sensitivities and to determine which allergen extract will be used for the skin test titration and inhalation A pre-allergen challenge methacholine test is conducted followed by sputum induction blood draw and nasal brushing On Day 2 of the triad the participant will inhale a dose of allergen that is 3 doubling doses lower than that estimated using methacholine test and skin titration to give a 20 fall in forced expiratory volume in 1 second The participant will continue inhaling doubling doses of allergen extract until a 20 fall in forced expiratory volume in 1 second has been reached Spirometry will be performed for 7 hours At 7h post-inhalation a bronchodilator will be administered and a sputum sample will be collected Participants will be sent home with bronchodilator to use if needed On Day 3 of the triad participants will return at approximately 24h post-allergen challenge for a methacholine test sputum induction blood draw and nasal brushing
Participants will also undergo a Triad 2 Days 1-3 for an inhaled challenge with 09 saline The intervention allergen or diluent will be randomized to Triad 1 or Triad 2 A four-week washout is required between allergen inhalation and a subsequent diluent inhalation A one-week washout is required between diluent inhalation and a subsequent allergen inhalation
Participants will also undergo a Triad 2 Days 1-3 for an inhaled challenge with 09 saline The intervention allergen or diluent will be randomized to Triad 1 or Triad 2 A four-week washout is required between allergen inhalation and a subsequent diluent inhalation A one-week washout is required between diluent inhalation and a subsequent allergen inhalation
Study Oversight
Has Oversight DMC:
None
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?:
None