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 work/school 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 ICS/LABA 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 work/school 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 ICS/LABA 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.
Brief Title
Improving the Quality of Care for Asthma Patients at Risk of Exacerbations
Detailed Description
Asthma affects 25 million people in the USA with a disproportionate effect on African American/Black (AA/B) and Hispanic/Latinx (H/L) 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 AA/B and H/L 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 AA/B and H/L 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 AA/B and H/L 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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
781-879-0946
Central Contact Email
nmaher@mgb.org
Completion Date
Completion Date Type
Estimated
Conditions
ASTHMA
ASTHMA CHRONIC
ASTHMA SEVERE PERSISTENT WITH EXACERBATION
ASTHMA MODERATE PERSISTENT WITH EXACERBATION
Eligibility Criteria
Inclusion Criteria:
* Clinician diagnosis of asthma for ≥1 year;
* Age at enrollment--18-75 years old inclusive;
* One or more AEXs that occurred \< 12 months prior to enrollment. An AEX is defined as an asthma deterioration that either requires 72 hours or more of an oral or parenteral steroids OR a hospital stay for more than 24 hours for asthma. In the case of patients on biologics for asthma, the exacerbation must have also occurred after at least 6 months of biologic therapy;
* Currently prescribed an ICS/LABA containing preparation containing at least the lowest dose of ICS described in Table 2 as regular daily maintenance therapy for at least one month;
* Has a rescue SABA containing inhaler that they have used on average at least once a month.
* Able to provide consent in English for the feasibility study or in English or Spanish for the full study.
Exclusion Criteria:
* Life expectancy \<2 years;
* COPD diagnosis unless: a) they were a never smoker; OR b) former smoker with normal pulmonary function tests (PFT; FEV1/FVC ratio of \>70%); OR c) current smoker with normal PFTs within 24 months of enrollment; OR d) current or former smoker with obstruction on PFTs (FEV1/FVC ratio of \<70% but who demonstrates BOTH \>12% acute bronchodilator reversibility AND a normal diffusing capacity both within 24 months of enrollment (criteria successfully used in PREPARE);
* Use of single inhaler product that contains an ICS, LAMA and LABA or one containing both LABA and LAMA within 1 month of enrollment;
* Use of current biologic for less than 6 months;
* Known allergy to any of the components of the intervention;
* Coexisting lung disease (e.g. Cystic Fibrosis, connective tissue disease (unless asthma preceded diagnosis of connective tissue disease by at least 2 years), prematurity-born at 32 weeks or sooner, organ transplantation, bronchiectasis, sarcoid, and obliterative bronchiolitis, among others)
* Has been in an asthma drug treatment trial in past 60 days or within 5 half-lives, whichever is longer, prior to study visit.
* Living in household with someone already enrolled in the study.
* Using daily or every other day oral corticosteroids for asthma or any other condition
* An AEX in the prior 4 weeks
* History of bronchial thermoplasty in prior 6 months
* Poorly or uncontrolled atrial fibrillation
* Not on stable asthma medications for at least 1 month prior to enrollment
* Using doses of ICS/LABA lower than the minimum below:
* Budesonide 320 ug,
* Fluticasone Advair Diskus/ Wixela 200-250 ug Advair HFA 180-230ug Airduo 110-113 ug Breo 100 ug
* Mometasone 200 ug
* Clinician diagnosis of asthma for ≥1 year;
* Age at enrollment--18-75 years old inclusive;
* One or more AEXs that occurred \< 12 months prior to enrollment. An AEX is defined as an asthma deterioration that either requires 72 hours or more of an oral or parenteral steroids OR a hospital stay for more than 24 hours for asthma. In the case of patients on biologics for asthma, the exacerbation must have also occurred after at least 6 months of biologic therapy;
* Currently prescribed an ICS/LABA containing preparation containing at least the lowest dose of ICS described in Table 2 as regular daily maintenance therapy for at least one month;
* Has a rescue SABA containing inhaler that they have used on average at least once a month.
* Able to provide consent in English for the feasibility study or in English or Spanish for the full study.
Exclusion Criteria:
* Life expectancy \<2 years;
* COPD diagnosis unless: a) they were a never smoker; OR b) former smoker with normal pulmonary function tests (PFT; FEV1/FVC ratio of \>70%); OR c) current smoker with normal PFTs within 24 months of enrollment; OR d) current or former smoker with obstruction on PFTs (FEV1/FVC ratio of \<70% but who demonstrates BOTH \>12% acute bronchodilator reversibility AND a normal diffusing capacity both within 24 months of enrollment (criteria successfully used in PREPARE);
* Use of single inhaler product that contains an ICS, LAMA and LABA or one containing both LABA and LAMA within 1 month of enrollment;
* Use of current biologic for less than 6 months;
* Known allergy to any of the components of the intervention;
* Coexisting lung disease (e.g. Cystic Fibrosis, connective tissue disease (unless asthma preceded diagnosis of connective tissue disease by at least 2 years), prematurity-born at 32 weeks or sooner, organ transplantation, bronchiectasis, sarcoid, and obliterative bronchiolitis, among others)
* Has been in an asthma drug treatment trial in past 60 days or within 5 half-lives, whichever is longer, prior to study visit.
* Living in household with someone already enrolled in the study.
* Using daily or every other day oral corticosteroids for asthma or any other condition
* An AEX in the prior 4 weeks
* History of bronchial thermoplasty in prior 6 months
* Poorly or uncontrolled atrial fibrillation
* Not on stable asthma medications for at least 1 month prior to enrollment
* Using doses of ICS/LABA lower than the minimum below:
* Budesonide 320 ug,
* Fluticasone Advair Diskus/ Wixela 200-250 ug Advair HFA 180-230ug Airduo 110-113 ug Breo 100 ug
* Mometasone 200 ug
Inclusion Criteria
Inclusion Criteria:
* Clinician diagnosis of asthma for ≥1 year;
* Age at enrollment--18-75 years old inclusive;
* One or more AEXs that occurred \< 12 months prior to enrollment. An AEX is defined as an asthma deterioration that either requires 72 hours or more of an oral or parenteral steroids OR a hospital stay for more than 24 hours for asthma. In the case of patients on biologics for asthma, the exacerbation must have also occurred after at least 6 months of biologic therapy;
* Currently prescribed an ICS/LABA containing preparation containing at least the lowest dose of ICS described in Table 2 as regular daily maintenance therapy for at least one month;
* Has a rescue SABA containing inhaler that they have used on average at least once a month.
* Able to provide consent in English for the feasibility study or in English or Spanish for the full study.
* Clinician diagnosis of asthma for ≥1 year;
* Age at enrollment--18-75 years old inclusive;
* One or more AEXs that occurred \< 12 months prior to enrollment. An AEX is defined as an asthma deterioration that either requires 72 hours or more of an oral or parenteral steroids OR a hospital stay for more than 24 hours for asthma. In the case of patients on biologics for asthma, the exacerbation must have also occurred after at least 6 months of biologic therapy;
* Currently prescribed an ICS/LABA containing preparation containing at least the lowest dose of ICS described in Table 2 as regular daily maintenance therapy for at least one month;
* Has a rescue SABA containing inhaler that they have used on average at least once a month.
* Able to provide consent in English for the feasibility study or in English or Spanish for the full study.
Gender
All
Gender Based
false
Keywords
ICS reliever therapy
Decrease exacerbations
iCARE
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT06596512
Org Class
Other
Org Full Name
Brigham and Women's Hospital
Org Study Id
2024P001955
Overall Status
Not yet recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Improving the Quality of Care for Asthma Patients at Risk of Exacerbations
Primary Outcomes
Outcome Description
The primary outcome is annualized rate of asthma exacerbations, defined as 72 hours of parenteral or oral corticosteroids to treat asthma symptoms or an asthma related-hospitalization. Participants are asked on their monthly surveys if they have had an exacerbation requiring at least 3 days of oral steroids or a hospitalization. If the participant answers yes to these questions, the clinical coordinating center contacts the site study coordinator to confirm an exacerbation in the patients EHR. If there is no record of an exacerbation in the EHR, the CCC contacts the patient for details. The information is entered into an exacerbation database and is reviewed separately by two investigators. If they are in agreement, the outcome is recorded (exacerbation yes or exacerbation no). If they do not agree or are unable to definitively determine if the patient had an exacerbation or not, the information goes to the adjudication committee of 3 for determination.
Outcome Measure
Exacerbations
Outcome Time Frame
Exacerbation information will be collected via monthly survey for 16 months.
Secondary Outcomes
Outcome Description
Asthma control represents the degree to which impairment (impact of asthma on patient's daily life) is minimized and the goals of therapy are met. The Asthma Control Test is a participant-administered tool for assessing the level of asthma control. Total scores range from 5 to 25, with a score of 20 to 25 indicating well-controlled asthma, a score of 16 to 19 indicating asthma that was not well controlled, and a score of 5 to 15 indicating very poorly controlled asthma. The minimal clinically important difference is 3 points
Outcome Time Frame
Monthly for 16 months
Outcome Measure
Asthma Control over time
Outcome Description
The ideal outcome measure for any comparative effectiveness analysis captures the risks and benefits for each of the interventions from the patient's point of view. The use of a preference-based instrument, the Asthma Symptom Utility Index (ASUI), captures this important information. The Asthma Symptom Utility Index is a participant-administered tool for assessing preference-based quality of life. Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The minimal clinically important difference is 0.09.
Outcome Time Frame
Monthly for 16 months
Outcome Measure
Asthma Symptom Utility Index (ASUI), Preference based quality of life
Outcome Description
Defined as days not able to work or go to school because of asthma symptoms OR days not able to carry out usual activities due to asthma
Outcome Time Frame
Monthly for 16 months
Outcome Measure
Days Lost Per Year From School/Work or Usual Activities
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Andrew Telzak
Investigator Email
atelzak@montefiore.org
Investigator Sponsor Organization
External
Study Department
Family and Social Medicine
Study Division
Please Specify
Categories Mesh Debug
Asthma and Other Respiratory Diseases --- BRONCHIAL DISEASES
Lung --- BRONCHIAL DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Lung --- LUNG DISEASES, OBSTRUCTIVE
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY HYPERSENSITIVITY
Lung --- RESPIRATORY HYPERSENSITIVITY
Immune System --- IMMUNE SYSTEM DISEASES
MeSH Terms
ASTHMA
BRONCHIAL DISEASES
RESPIRATORY TRACT DISEASES
LUNG DISEASES, OBSTRUCTIVE
LUNG DISEASES
RESPIRATORY HYPERSENSITIVITY
HYPERSENSITIVITY, IMMEDIATE
HYPERSENSITIVITY
IMMUNE SYSTEM DISEASES