Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596512
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Improving the Quality of Care for Asthma Patients at Risk of Exacerbations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improving the Quality of Care for Asthma Patients at Risk of Exacerbations
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iCARE
Brief Summary:
The goal of this trial test two known effective asthma strategies Treatment guidelines recommend combination therapy of inhaled corticosteroids ICS with a long-acting beta-agonist LABA inhaled medications This strategy is known as MART maintenance and reliever therapy The second strategy is PARTICS patient activated reliever triggered ICS strategy instructs patients to use an ICS metered dose inhaler ICS each time they use their rescue inhaler In addition they are instructed to take 5 puffs of the ICS after each rescue nebulizer use PARTICS has been shown to reduce exacerbations increase asthma control and quality of life however the question remains if PARTICS is as effective as MART and therefore be an alternative to MART This trial will test PARTICS and MART head-to-head
The trial will include adults with moderate-to-severe asthma at risk for an asthma exacerbation currently using a combination ICS
The main questions aim to answer
Is PARTICS as effective as SMART
Might PARTICS be more effective than SMART Is the relative effectiveness of PARTICS versus SMART affected by frequent nebulizer use for asthma relief
Do PARTICS and SMART diverge in terms of their effectiveness on differing asthma outcomes important to patients
Do socioeconomic factors affect the relative effectiveness of PARTICS and SMART Researchers will compare non frequent nebulizer NFN users - less than once a week to frequent nebulizer users - once a week or more to assess whether the PARTICS strategy is ono-inferior or superior to the MART strategy in reducing exacerbations primary outcome increasing asthma control and quality of life and decrease days lost from workschool or usual activities
Most participants will be consented enrolled and randomized virtually others will be consented enrolled and randomized in person Once randomized they will be instructed on how to use the prescribed medication
Participants randomized to MART will be instructed to use the prescribed ICSLABA for maintenance and as needed for rescue
Participants randomized to PARTICS will be instructed to use the prescribed ICS each time they use their rescue inhaler and take 5 puffs of the newly prescribed ICS after each rescue nebulizer use
Participants will be followed for 16 months by monthly survey
The trial will include adults with moderate-to-severe asthma at risk for an asthma exacerbation currently using a combination ICS
The main questions aim to answer
Is PARTICS as effective as SMART
Might PARTICS be more effective than SMART Is the relative effectiveness of PARTICS versus SMART affected by frequent nebulizer use for asthma relief
Do PARTICS and SMART diverge in terms of their effectiveness on differing asthma outcomes important to patients
Do socioeconomic factors affect the relative effectiveness of PARTICS and SMART Researchers will compare non frequent nebulizer NFN users - less than once a week to frequent nebulizer users - once a week or more to assess whether the PARTICS strategy is ono-inferior or superior to the MART strategy in reducing exacerbations primary outcome increasing asthma control and quality of life and decrease days lost from workschool or usual activities
Most participants will be consented enrolled and randomized virtually others will be consented enrolled and randomized in person Once randomized they will be instructed on how to use the prescribed medication
Participants randomized to MART will be instructed to use the prescribed ICSLABA for maintenance and as needed for rescue
Participants randomized to PARTICS will be instructed to use the prescribed ICS each time they use their rescue inhaler and take 5 puffs of the newly prescribed ICS after each rescue nebulizer use
Participants will be followed for 16 months by monthly survey
Detailed Description:
Asthma affects 25 million people in the USA with a disproportionate effect on African AmericanBlack AAB and HispanicLatinx HL patients Inhaled corticosteroids are the backbone of asthma therapy A so-called SMART Single Maintenance And Reliever Therapy approach to ICS therapy has been recommended by US and international guidelines for patients with moderate to severe asthma because it has been shown in multiple studies to reduce asthma exacerbations However these studies have been explanatory with narrow entry criteria have only been performed ex- US with a formulation not available in the US and have not included significant numbers of AAB and HL patients
Further there are significant barriers to implementation which include those related to patient patterns of concomitant medication use and beliefs In a PCORI-funded pragmatic study in 1200 AAB and HL patients with asthma designed with patient partners we studied an alternative approach we call PARTICS Patient Activated Reliever Triggered ICS We reported in this study published in the New England Journal of Medicine in 2022 that we not only reduced asthma exacerbations we also improved other outcomes important to patients including asthma control quality of life and days lost from school work or usual activities Our patient advisors have published on their positive experience and other advisors have collaborated with us to publish 9 additional papers which include such topics as an exploration of how socioeconomic factors affect asthma outcomes and how to simply identify patients at risk for asthma exacerbations among additional topics Both SMART and PARTICS have advantages and drawbacks As seen in letters of support from the heads of the US and international guidelines for asthma treatment committees the lack of direct comparison between the two represents a major gap in knowledge required to formulate best-care practice recommendations
Specifically it is unclear as to what degree one approach can substitute for the other and whether they differentially affect distinct domains of asthma outcomes In collaboration with our advisors we therefore propose iCARE Improving the Quality of Care for Asthma patients at Risk of Exacerbations a large pragmatic study to directly compare SMART to PARTICS in diverse populations and across multiple domains The study results regardless of outcome will help guide the approach to patient-centered asthma care
Further there are significant barriers to implementation which include those related to patient patterns of concomitant medication use and beliefs In a PCORI-funded pragmatic study in 1200 AAB and HL patients with asthma designed with patient partners we studied an alternative approach we call PARTICS Patient Activated Reliever Triggered ICS We reported in this study published in the New England Journal of Medicine in 2022 that we not only reduced asthma exacerbations we also improved other outcomes important to patients including asthma control quality of life and days lost from school work or usual activities Our patient advisors have published on their positive experience and other advisors have collaborated with us to publish 9 additional papers which include such topics as an exploration of how socioeconomic factors affect asthma outcomes and how to simply identify patients at risk for asthma exacerbations among additional topics Both SMART and PARTICS have advantages and drawbacks As seen in letters of support from the heads of the US and international guidelines for asthma treatment committees the lack of direct comparison between the two represents a major gap in knowledge required to formulate best-care practice recommendations
Specifically it is unclear as to what degree one approach can substitute for the other and whether they differentially affect distinct domains of asthma outcomes In collaboration with our advisors we therefore propose iCARE Improving the Quality of Care for Asthma patients at Risk of Exacerbations a large pragmatic study to directly compare SMART to PARTICS in diverse populations and across multiple domains The study results regardless of outcome will help guide the approach to patient-centered asthma care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None