Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| American Academy of Family Physicians | OTHER |
Not provided
Not provided
Not provided
Asthma imposes a significant burden in the US in terms of morbidity, costs to society, individual suffering, loss of productivity and mortality. African Americans (AA) and Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite national guidelines for asthma treatment, the gap between these groups and whites has been stable or widening. The need for pragmatic research to address the continuing burden is widely recognized. Patients use asthma reliever inhalers to provide immediate relief of symptoms. Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used regularly to prevent symptoms and attacks. Guidelines suggest that they be used daily, on a fixed basis, in all but the mildest asthma. However, adherence by patients and implementation of evidence-based guideline recommendations by clinicians has been poor. Gap analysis suggests that it is difficult to improve adherence to the current recommendations without complex and resource-intensive interventions. Studies have examined symptom-activated use of ICS triggered by use of a reliever medication. The Investigators call this approach PARTICS - Patient Activated Reliever-Triggered Inhaled CorticoSteroid. Explanatory, non-real world studies suggest that PARTICS can produce up to 50% reductions in asthma attacks compared with usual care, while reducing ICS use by half or more. These studies have been performed in pre-selected populations, which represent less than 5% of asthma patients. The previous studies have been done with repeated education and adherence checks in both the intervention and control arms.
The investigators have consulted with AA and H/L patients, health care providers, leaders of professional societies, advocacy groups, health policy leaders, pharmacists, and pharmaceutical manufacturers. All groups have indicated that asthma decision making would be changed if we demonstrated that implementing PARTICS improves important asthma outcomes such as reducing exacerbations. The Investigators have designed a study with the stakeholders to determine whether PARTICS can improve outcomes that are important to patients when superimposed on a background provider-educated standard of care through the Asthma IQ system. The Investigators propose a study entitled PREPARE: Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations. The Investigators aim to determine whether PARTICS can reduce asthma morbidity in AA and H/L.
Asthma imposes a significant burden on the US population in terms of morbidity, costs to society, individual suffering, loss of productivity and mortality. African Americans (AA) and Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite introduction of national guidelines for asthma treatment, the gap between these groups and whites has been stable or widening. The need for pragmatic research to address the continuing burden is widely recognized. Patients use asthma reliever inhalers to provide immediate relief of symptoms. Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used regularly to prevent symptoms and attacks. Guidelines suggest that they be used daily, on a fixed basis, in all but the mildest asthma. However, adherence by patients and implementation of evidence-based guideline recommendations by clinicians has been poor. Gap analysis suggests that it is difficult to improve adherence to the current recommendations without complex and resource-intensive interventions.
Studies have examined symptom-activated use of ICS triggered by use of a reliever medication. We call this approach PARTICS - Patient Activated Reliever-Triggered Inhaled CorticoSteroid. Explanatory, non-real world studies suggest that PARTICS can produce up to 50% reductions in asthma attacks compared with usual care, while reducing ICS use by half or more. However, these studies have been performed in pre- selected populations, which represent less than 5% of patients with asthma. They have been done with repeated education and adherence checks in both the intervention and control arms.
The investigators have consulted with AA and H/L patients, health care providers, leaders of professional societies, advocacy groups, health policy leaders, pharmacists, and pharmaceutical manufacturers. All groups have indicated that asthma decision making would be changed if it was demonstrated that implementing PARTICS improves important asthma outcomes such as reducing rates of exacerbations. Together with our partners and stakeholders, the investigators have designed a study to determine whether PARTICS can improve outcomes that are important to patients when superimposed on a background provider-educated standard care through the Asthma IQ system. The investigators therefore propose a study entitled PREPARE: Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations. The aim is to determine whether a PARTICS strategy can reduce asthma morbidity in AA and H/L. The primary outcome will be asthma exacerbations which have been shown to be important to patient and healthcare stakeholders. The secondary outcomes will include additional outcomes important to patients (i.e. days lost from work or school, asthma control, & asthma quality of life). The investigators have broad input and involvement from multiple stakeholder groups in study design, implementation, and commitments for dissemination. AA and H/L patients and their advocates have been involved and will continue to play a central role in all phases of the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PARTICS | Active Comparator | addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use |
|
| Usual Care | No Intervention | Provider-enhanced usual care arm; no change in asthma management |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PARTICS using QVAR | Drug | Patient takes inhaled corticosteroid at the time of rescue inhaler use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Asthma Exacerbations Per Year | Our primary outcome, the rate of asthma exacerbations per year, is defined as the number of exacerbations, emergency room visits, or hospitalizations requiring oral or parenteral corticosteroids, per patient per year | monthly through study completion an average of 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline | 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 |
Not provided
INCLUSION CRITERIA
EXCLUSION CRITERIA
Life expectancy less than one year
Known allergy to the ICS inhaler used in the study
Having COPD or other chronic lung disease other than asthma; with the exception of the following:
Regular systemic corticosteroid use daily or every other day for any reason-including asthma or other medical reasons
Use of systemic corticosteroid, or visit to the doctor's office, emergency department (ED) or urgent care, or overnight hospitalization for an asthma exacerbation in the past month (can wait and re-check eligibility after one month)
Use of biologics (injections or infusion medicines): with the exception of the following:
Bronchial thermoplasty less than 6 months ago (can re-check eligibility 6 months after procedure)
Another family member living in the same household already enrolled in study
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elliot Israel, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| University of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39578039 | Derived | Callen E, Israel E, Cardet JC, Fuhlbrigge AL, Manning B, Gaona G, Staton E, Pace WD. Electronic health record data analysis on the impact of rescue-triggered inhaled corticosteroids on controller therapy in Black and Latinx individuals from a pragmatic, open-label, patient-level randomised trial. BMJ Open. 2024 Nov 21;14(11):e088349. doi: 10.1136/bmjopen-2024-088349. | |
| 38000696 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
1220 participants were enrolled, however, 19 participants were not followed and were dropped from analysis due to the site closure. They were not included in the primary analyses but were included in safety reporting. Two sites were enrolling simultaneously and there was one additional participant enrolled accidentally.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PARTICS | addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use PARTICS using QVAR: Patient takes inhaled corticosteroid at the time of rescue inhaler use |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Monthly through study completion an average of 15 months |
| Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI), Least-squares Mean Change From Baseline | 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. | Monthly through study completion an average of 15 months |
| Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma | 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 | Monthly through study completion an average of 15 months |
| Los Angeles |
| California |
| 90033 |
| United States |
| Denver Health and Hospital Authority | Denver | Colorado | 80209 | United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Grace Medical Home | Orlando | Florida | 32827 | United States |
| University of Central Florida | Orlando | Florida | 32827 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| University of Illinois- Chicago | Chicago | Illinois | 60607 | United States |
| Baystate Health Center | Springfield | Massachusetts | 01199 | United States |
| Mt. Sinai | New York | New York | 10029 | United States |
| Montefiore | The Bronx | New York | 10461 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 25799 | United States |
| Atrium Health | Charlotte | North Carolina | 28207 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| MetroHealth | Cleveland | Ohio | 44109 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Temple University | Philadelphia | Pennsylvania | 19122 | United States |
| University of Puerto Rico | San Juan | 00926 | Puerto Rico |
| Ishmael L, Apter A, Busse PJ, Calderon-Candelario R, Carroll JK, Casale T, Celedon JC, Cohen R, Coyne-Beasley T, Cui J, Ericson B, Hernandez P, Kaelber DC, Maher N, Merriman C, Mosnaim G, Nazario S, Phipatanakul W, Pinto-Plata V, Riley I, Shenoy K, Wisnivesky J, Yawn B, Israel E, Cardet JC. Asthma morbidity measures across Black ethnic subgroups. J Allergy Clin Immunol. 2024 Feb;153(2):408-417. doi: 10.1016/j.jaci.2023.10.028. Epub 2023 Nov 23. |
| 37490981 | Derived | Ugalde IC, Ratigan A, Merriman C, Cui J, Ericson B, Busse P, Carroll JK, Casale T, Celedon JC, Coyne-Beasley T, Fagan M, Fuhlbrigge AL, Villarreal GG, Hernandez PA, Jariwala S, Kruse J, Maher NE, Manning B, Mosnaim G, Nazario S, Pace WD, Phipatanakul W, Pinto-Plata V, Riley I, Rodriguez-Louis J, Salciccioli J, Shenoy K, Shields JB, Tarabichi Y, Sosa BT, Wechsler ME, Wisnivesky J, Yawn B, Israel E, Cardet JC. Preference for and impact of telehealth vs in-person asthma visits among Black and Latinx adults. Ann Allergy Asthma Immunol. 2023 Nov;131(5):614-627.e2. doi: 10.1016/j.anai.2023.07.012. Epub 2023 Jul 23. |
| 37468217 | Derived | Forth VE, Cardet JC, Chang KL, Ericson B, Hurley LP, Maher NE, Staton EW, Sosa BT, Israel E; PREPARE investigators. What Patients Call Their Inhalers Is Associated with "Asthma Attacks". J Am Board Fam Med. 2023 Aug 9;36(4):650-661. doi: 10.3122/jabfm.2022.220270R2. Epub 2023 Jul 19. |
| 35779669 | Derived | Cardet JC, Shenoy K, Baydur A, Carroll JK, Celedon JC, Cui J, Dara P, Ericson B, Forth VE, Fagan M, Fuhlbrigge AL, Gupta R, Hart MK, Hernandez ML, Hernandez PA, Kruse J, Maher NE, Manning BK, Pinto-Plata VM, Robles J, Rodriguez-Louis J, Shields JB, Telon Sosa BS, Wechsler ME, Israel E. Caribbean Latinx with moderate-severe asthma bear greater asthma morbidity than other Latinx. J Allergy Clin Immunol. 2022 Nov;150(5):1106-1113.e10. doi: 10.1016/j.jaci.2022.05.026. Epub 2022 Jun 30. |
| 35213105 | Derived | Israel E, Cardet JC, Carroll JK, Fuhlbrigge AL, She L, Rockhold FW, Maher NE, Fagan M, Forth VE, Yawn BP, Arias Hernandez P, Kruse JM, Manning BK, Rodriguez-Louis J, Shields JB, Ericson B, Colon-Moya AD, Madison S, Coyne-Beasley T, Hammer GM, Kaplan BM, Rand CS, Robles J, Thompson O, Wechsler ME, Wisnivesky JP, McKee MD, Jariwala SP, Jerschow E, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter AJ, Chang KL, Pinto-Plata V, Stranges PM, Hurley LP, Trevor J, Casale TB, Chupp G, Riley IL, Shenoy K, Pasarica M, Calderon-Candelario RA, Tapp H, Baydur A, Pace WD. Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma. N Engl J Med. 2022 Apr 21;386(16):1505-1518. doi: 10.1056/NEJMoa2118813. Epub 2022 Feb 26. |
| 31923550 | Derived | Cardet JC, Busse PJ, Carroll JK, Casale TB, Coyne-Beasley T, Dixon-Williams S, Fagan M, Forth VE, Fuhlbrigge AL, Hernandez ML, Kaelber D, Kaplan B, Lorenzi M, Madison S, Maher NE, Majewski K, Manning B, McKee MD, Nazario S, Pace WD, Pencina MJ, Rand CS, Rodriguez-Louis J, She L, Shields J, Teng JE, Wechsler ME, Wisnivesky JP, Yawn BP, Israel E. Adherence to adding inhaled corticosteroids to rescue therapy in a pragmatic trial with adults with asthma: A pilot study. Ann Allergy Asthma Immunol. 2020 May;124(5):487-493.e1. doi: 10.1016/j.anai.2019.12.027. Epub 2020 Jan 8. |
| Usual Care |
Provider-enhanced usual care arm; no change in asthma management |
| COMPLETED |
|
| NOT COMPLETED |
|
|
19 participants were dropped from analysis due to the site closure. They were not followed and not included in any analyses.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PARTICS | addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use PARTICS using QVAR: Patient takes inhaled corticosteroid at the time of rescue inhaler use |
| BG001 | Usual Care | Provider-enhanced usual care arm; no change in asthma management |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Body mass index (BMI) (kg/m2) | Mean | Standard Deviation | kilograms per meters squared |
| |||||||||||||||
| Obesity | The body-mass index is the weight in kilograms divided by the square of the height in meters. Obesity was defined as a body-mass index of 30 or higher. | Count of Participants | Participants |
| |||||||||||||||
| Smoking status | Current smokers were defined as participants who were currently smoking or had smoked within the previous year. Former smokers were participants who had not smoked in the previous year but had smoked at least 10 pack-years. Nonsmokers were those who had not smoked within the previous year and had smoked less than 10 pack-years. | Count of Participants | Participants |
| |||||||||||||||
| Nonsmoker or former smoker in smoking environment | A smoking environment was defined as others regularly smoking in the participant's home, work, or car. | Count of Participants | Participants |
| |||||||||||||||
| Number of pack-years of smoking | 376 participants answered questions about smoking pack-years. Non-smokers are those who have not smoked within 1 year and have smoked less than 10 pack-years in their lifetime. 143 are current smokers, 100 are former smokers, and 133 are non-smokers with less than 10 pack-years. | Mean | Standard Deviation | pack-years |
| ||||||||||||||
| Maintenance asthma medications: Inhaled glucocorticoid without long-acting beta-agonist | Medication categories are not mutually exclusive and therefore are reported separately. | Count of Participants | Participants |
| |||||||||||||||
| Maintenance asthma medications: Combination inhaled glucocorticoid with long-acting beta-agonist | Medication categories are not mutually exclusive and therefore are reported separately. | Count of Participants | Participants |
| |||||||||||||||
| Maintenance asthma medications: Long-acting muscarinic antagonist | Medication categories are not mutually exclusive and therefore are reported separately. | Count of Participants | Participants |
| |||||||||||||||
| Maintenance asthma medications: Leukotriene-receptor antagonist | Medication categories are not mutually exclusive and therefore are reported separately. | Count of Participants | Participants |
| |||||||||||||||
| Maintenance asthma medications: Biologic agent | Medication categories are not mutually exclusive and therefore are reported separately. Biologic agents included injectable monoclonal antibody therapies targeting IgE, interleukin-5 or the interleukin-5 receptor, or the interleukin-4 receptor. | Count of Participants | Participants |
| |||||||||||||||
| Use of quick-reliever nebulizer | Count of Participants | Participants |
| ||||||||||||||||
| Number of quick-reliever nebulizations per week | Only participants who reported using a nebulizer are included in this measure. | Mean | Standard Deviation | Nebulizations per week |
| ||||||||||||||
| Number of coexisting conditions | Coexisting conditions included heart disease, cancer (except skin cancer), stroke, diabetes, chronic kidney disease, chronic obstructive pulmonary disease, human immunodeficiency virus infection or acquired immunodeficiency syndrome, hypertension, depression, and sleep disorder. | Count of Participants | Participants |
| |||||||||||||||
| Fractional exhaled nitric oxide (FeNO) | 1003 participants had FeNO data available for analysis. | Mean | Standard Deviation | ppb |
| ||||||||||||||
| Fractional exhaled nitric oxide (FeNO), ≥30 ppb | 1003 participants had FeNO data available for analysis. | Count of Participants | Participants |
| |||||||||||||||
| Absolute eosinophil count | 996 participants had eosinophil count data available for analysis. | Mean | Standard Deviation | cells/μL |
| ||||||||||||||
| Absolute eosinophil count | 996 participants had eosinophil count data available for analysis. | Median | Full Range | cells/μL |
| ||||||||||||||
| Absolute eosinophil count ≥300 cells/μL | 996 participants had eosinophil count data available for analysis. | Count of Participants | Participants |
| |||||||||||||||
| History of ≥1 asthma exacerbation in past year | Asthma exacerbation in the previous year was defined as a participant-reported emergency department or urgent care visit, hospitalization, or course of systemic glucocorticoids within the 12 months before randomization. | Count of Participants | Participants |
| |||||||||||||||
| Asthma Control Test score | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Asthma Symptom Utility Index score | 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. | One participant in the Usual Care group is missing baseline ASUI data. | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| Medication Adherence Report Scale-5 score | The Medication Adherence Report Scale-5 measures participant-reported medication adherence. Mean scores are calculated from five items and range from 1 to 5, with higher scores indicating better adherence. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Low or marginal health literacy | Health literacy was assessed with the Brief Health Literacy Scale, which measures participant-reported health literacy and consists of three items. Scoring low or marginal health literacy on any one item classifies a participant as having low or marginal health literacy. | One participant in the PARTICS group is missing baseline data measuring health literacy. | Count of Participants | Participants |
| ||||||||||||||
| Participant-perceived overall health | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Asthma Exacerbations Per Year | Our primary outcome, the rate of asthma exacerbations per year, is defined as the number of exacerbations, emergency room visits, or hospitalizations requiring oral or parenteral corticosteroids, per patient per year | Posted | Mean | 95% Confidence Interval | Adjusted annualized exacerbations | monthly through study completion an average of 15 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline | 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 | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Monthly through study completion an average of 15 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI), Least-squares Mean Change From Baseline | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Monthly through study completion an average of 15 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma | 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 | Posted | Mean | 95% Confidence Interval | days per year | Monthly through study completion an average of 15 months |
|
|
From enrollment to study completion, an average of 15 months per participant.
SAE was defined as any event that resulted in death, hospitalization, persistent/significant disability, or congenital anomaly/birth defect; or was otherwise life-threatening. Data on adverse events that resulted in hospitalization or death were obtained by participant report or site report. Adverse events were not monitored/assessed with regard to the specific Adverse Event Term.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PARTICS | addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use PARTICS using QVAR: Patient takes inhaled corticosteroid at the time of rescue inhaler use | 3 | 609 | 75 | 609 | 0 | 609 |
| EG001 | Usual Care | Provider-enhanced usual care arm; no change in asthma management | 4 | 611 | 74 | 611 | 0 | 611 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cardiac events | Cardiac disorders | Non-systematic Assessment |
| ||
| Gastrointestinal disorders | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hematology/oncology | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Immune system disorders | Immune system disorders | Non-systematic Assessment |
| ||
| Infections and infestations | Infections and infestations | Non-systematic Assessment |
| ||
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Nervous system disorders | Nervous system disorders | Non-systematic Assessment |
| ||
| Psychiatric disorders | Psychiatric disorders | Non-systematic Assessment |
| ||
| Renal/urinary disorders | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Reproductive system and breast disorders | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Respiratory, thoracic, mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Substance abuse | Psychiatric disorders | Non-systematic Assessment |
| ||
| Vascular disorders | Vascular disorders | Non-systematic Assessment |
| ||
| Unclassified elsewhere | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elliot Israel | Brigham and Women's Hospital | 617-732-8110 | eisrael@bwh.harvard.edu |
| Jan 10, 2022 |
| Prot_SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
|
|
|
| United States |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|