AsthmaPhase 4PREPARENCT02995733
Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief
A Phase 4 study testing PARTICS using QVAR in people with Asthma, run by Brigham and Women's Hospital at 20 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- PARTICS using QVAR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,220 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 27 Nov 2017to 30 Apr 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Black or Hispanic based on self-identification (Hispanic if identify as both)
- Male and female, ages 18-75 years
- Ability to provide informed consent
- Clinical history consistent with asthma for > 1 year.
- Prescribed ICS as daily maintenance therapy
- Participant must also have an ACT score of 19 or less, or a history of one or more exacerbations in the past year that required patient report of systemic corticosteroid use.
Who cannot join
- 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:
- Dx of COPD in a never smoker without any other lung disease or any other disease that might cause airway obstruction such as: Cystic Fibrosis, Connective Tissue Disease, premature birth, organ transplantation, bronchiectasis, sarcoid, and obliterative bronchiolitis
- Dx of COPD in former smoker with normal PFTs done after the person quit smoking
- Dx of COPD in current smoker with normal PFTs done in past 24 months
Show all 15Show fewer
- Dx of COPD IN CURRENT OR FORMER SMOKER with obstruction on PFTs: normal diffusing capacity in past 24 months and demonstrated reversibility of 12% or more at any time
- 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:
- the patient has been on a stable dose of a biologic for at least 6 months and,
- must have had an exacerbation at least 2 months after starting on a biologic to be considered eligible OR
- must have a current ACT score <=19 to be considered eligible.
- 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
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States19 sites
University of Alabama
Birmingham, Alabama, 35294
University of North Carolina
Chapel Hill, North Carolina, 25799
Atrium Health
Charlotte, North Carolina, 28207
University of Illinois- Chicago
Chicago, Illinois, 60607
MetroHealth
Cleveland, Ohio, 44109
Denver Health and Hospital Authority
Denver, Colorado, 80209
Duke University
Durham, North Carolina, 27705
University of Florida
Gainesville, Florida, 32610
University of Southern California
Los Angeles, California, 90033
University of Miami
Miami, Florida, 33136
Yale University
New Haven, Connecticut, 06510
Mt. Sinai
New York, New York, 10029
Grace Medical Home
Orlando, Florida, 32827
University of Central Florida
Orlando, Florida, 32827
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University
Philadelphia, Pennsylvania, 19122
Baystate Health Center
Springfield, Massachusetts, 01199
University of South Florida
Tampa, Florida, 33613
Montefiore
The Bronx, New York, 10461
About this study
Official title: Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations
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.
Read the detailed description
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.
- Conditions
- Asthma
- Being tested
- PARTICS using QVAR
- Keywords
- asthma, African Americans, Hispanics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARTICS using QVARDrug
Also called Patient Activated Reliever-Triggered Inhaled CorticoSteroid
Patient takes inhaled corticosteroid at the time of rescue inhaler use
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: PARTICS using QVAR |
| Usual Care | No intervention | Provider-enhanced usual care arm; no change in asthma management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: monthly through study completion an average of 15 months
Secondary outcomes (3)
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
Measured: 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.
Measured: 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
Measured: Monthly through study completion an average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start27 Nov 2017
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, American Academy of Family Physicians
- Responsible party
- Principal investigator, Elliot Israel, MD, Brigham and Women's Hospital
- Investigators
- Elliot Israel, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995733
- Sponsor's protocol ID
- 2016P001839
- Acronym
- PREPARE
- Status last verified
- Dec 2022
- First submitted
- 9 Nov 2016
- Last updated
- 19 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39578039Ishmael 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.
PubMed 38000696Ugalde 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.
PubMed 37490981Forth 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.
PubMed 37468217Cardet 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.
PubMed 35779669Israel 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.
PubMed 35213105Cardet 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.
PubMed 31923550
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations
- ClinicalTrials.gov ID
- NCT02995733
- Acronym / sponsor ID
- PREPARE / 2016P001839
- Conditions
- Asthma
- Keywords
- asthma, African Americans, Hispanics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,220 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, American Academy of Family Physicians
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Posted 19 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PARTICS | Active comparator | Drug: PARTICS using QVARaddition 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Black or Hispanic based on self-identification (Hispanic if identify as both)
- Male and female, ages 18-75 years
- Ability to provide informed consent
- Clinical history consistent with asthma for > 1 year.
- Prescribed ICS as daily maintenance therapy
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PARTICS using QVARAlso: Patient Activated Reliever-Triggered Inhaled CorticoSteroidPatient takes inhaled corticosteroid at the time of rescue inhaler use | Drug | PARTICS |
Primary outcome
Rate of Asthma Exacerbations Per Year
Time frame: monthly through study completion an average of 15 months
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
3 secondary outcomes
Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline
Time frame: 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
Time frame: 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
Time frame: Monthly through study completion an average of 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39578039Callen 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.
- Derived from this study: PubMed 38000696Ishmael 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.
- Derived from this study: PubMed 37490981Ugalde 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.
- Derived from this study: PubMed 37468217Forth 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.
- Derived from this study: PubMed 35779669Cardet 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.
- Derived from this study: PubMed 35213105Israel 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.
- Derived from this study: PubMed 31923550Cardet 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliot Israel, MD principal investigator
Brigham and Women's Hospital
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PARTICS using QVAR in people with Asthma, run by Brigham and Women's Hospital at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Asthma Exacerbations Per Year (time frame: monthly through study completion an average of 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02995733, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.