Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272370
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-10
Brief Title:
Individualizing Treatment for Asthma in Primary Care
Sponsor:
DARTNet Institute
Organization:
DARTNet Institute
Study Overview
Official Title:
Individualizing Treatment for Asthma in Primary Care
Status:
RECRUITING
Status Verified Date:
2024-02
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:
iTREAT-PC
Brief Summary:
This is a patient level randomized trial for teenagers and adults with asthma who will be randomized to four arms - enhance usual care rescue inhaled corticosteroids azithromycin and both rescue inhaled corticosteroids and azithromycin Participants in all arms will be offered access to an online asthma symptom monitoring system
Detailed Description:
Design Current activities consist of a Feasibility study to test all activities prior to the full study The Feasibility study will involve only 5 centers and each participant will be involved for only 3 months The study will consist of a four arm patient level randomized trial N125 Comparators Rescue Inhaled Corticosteroids R-ICS versus azithromycin versus R-ICS plus azithromycin versus enhanced usual care patients All arms will include home monitoring of asthma symptoms using various approaches R-ICS therapy will consist of a corticosteriodformoterol inhaler or a stand-alone ICS inhaler used with usual rescue therapy or when available a combination corticosteroidalbuterol inhaler the initial azithromycin dose will be 500mg 10mgKg three times a week and may be titrated down to 250mg 10mgKg three times per week for side effects Exacerbations will be blindly adjudicated Individuals who experience three exacerbations in 12 months in the full study will have their treatments stepped-upunless in the dual treatment arm control participants going to R-ICS and single therapy participants to dual therapy In the full study after a step-up participants will be followed for an additional 12 months There will be no step-up during the Feasibility phase Individuals completing either of the azithromycin arms will be offered 6 additional months of follow-up after stopping the azithromycin only
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None